Digestive Disease Week (DDW 2011)

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Inspection of the mucosa during colonoscope insertion does not increase adenoma detection rates at colonoscopy, according to data from a randomized trial presented at the annual Digestive Disease Week.

At least one adenoma was detected in 52% of patients who were randomly assigned to inspection during both insertion and withdrawal of the colonoscope, and in 58% of patients who were inspected only during withdrawal. The total inspection time was the same, at about 9 minutes. The two groups were labeled the "insertion group" and "withdrawal group."

The mean number of adenomas detected was 1.4 vs. 1.8 in the insertion and withdrawal groups, respectively. The groups were also similar with regard to such secondary end points as dose of propofol used for sedation (345 mg vs. 330 mg, respectively) and postprocedure pain assessed using a visual analog scale (1.2 vs. 1.1).

"Inspection during colonoscope insertion offered no additional benefit, compared with an equivalent period of inspection performed entirely during instrument withdrawal," Dr. David G. Hewett said.

Colonoscopy is typically performed with inspection only on withdrawal. This can be problematic because polyps that are visualized and not removed during instrument insertion sometimes cannot to be found during the withdrawal phase. This may be because views of the mucosa are different on insertion, because of conformational differences in colonic anatomy, such that the colon is shortened and pleated over the instrument during withdrawal, explained Dr. Hewett of Indiana University, Indianapolis, and the University of Queensland, Herston (Australia).

Dr. Hewett and his colleague Dr. Douglas K. Rex, distinguished professor of medicine at Indiana University and director of endoscopy at Indiana University Hospital, randomly assigned 340 patients undergoing routine screening or surveillance colonoscopy to 6 minutes of inspection during instrument withdrawal and an additional 3 minutes of inspection during either instrument insertion or withdrawal.

Inspection time (defined as time spent in active inspection of the mucosa) was measured with a stopwatch by a research assistant. The stopwatch was stopped for washing, suction, red-out, polypectomy, or biopsy. The colonoscopies were performed by two experienced endoscopists using high-definition colonoscopes (Olympus H180AL).

The 171 insertion patients and 169 withdrawal patients had similar baseline characteristics, including mean age (62.6 years vs. 63.6 years), indication (surveillance for 65% vs. 68%) and bowel preparation (excellent in 60% vs. 62%).

In all, 299 adenomas were detected in 187 patients, and the overall adenoma detection rate was 55%, Dr. Hewett said. Twelve patients had high-grade dysplasia or villous histology, and no cancers were detected.

Importantly, there were no significant differences in total procedure time or total inspection time, he said. Specifically, total procedure times were 24.2 minutes in the insertion group vs. 27.5 minutes in the withdrawal group, whereas total inspection times were 9.6 minutes vs. 9.4 minutes. As expected from the study design, mean withdrawal inspection times were 6.5 minutes in the insertion group and 9.4 minutes in the withdrawal group.

After adjustment for demographic, clinical, and procedural variables (age, sex, indication, endoscopist, and bowel preparation quality), there were no significant differences between groups in rates of adenoma detection or numbers of adenomas detected, Dr. Hewett said.

"We conclude that these results do not support a role for routine inspection during colonoscope insertion," he said.

During a discussion of the study, an attendee asked whether insertion times were equivalent, or whether the endoscopist simply "zipped" to the cecum when the 3 minutes had elapsed. This concern was echoed by session cochair Dr. Walter Coyle of the Scripps Clinic in La Jolla, Calif., who said he’s had fellows who can still be in the rectum at 3 minutes. Dr. Hewett replied that insertion times were similar between groups, and that the endoscopists were typically pretty close to the cecum in the proximal ascending colon at 3 minutes.

Another attendee asked whether the internal review board and patients were made aware of the theoretical risk of polyp perforation if polyps are removed during insertion. Dr. Hewett said they were not required to disclose this and that it is not something they’re typically worried about.

Dr. Coyle asked whether the researchers remove large (2- to 3- cm) polyps upon insertion, adding, "I tend to biopsy the site, so I can find it on the way back and take it on the way out because of that same concern, but I’m sort of old school."

Dr. Hewett replied that yes, they removed large polyps upon insertion, but could not provide specifics on how often this happened during the study.

During the same session at DDW about colonoscopy techniques, researchers reported survey results indicating that endoscopists who remove all polyps irrespective of size during insertion and those who remove only small polyps less than 5 mm in size during insertion had higher adenoma detection rates, compared with those who remove polyps only during withdrawal (28.7% vs. 25% vs. 16.7%; P = .045). Similarly, their proximal adenoma detection rates were also higher (17.5% vs. 16.5% vs. 9%; P = .02), said Dr. Madhusudhan Sanaka of the Cleveland Clinic. The 19-item survey was completed in 2010 by a multispecialty group of 42 endoscopists including 29 gastroenterologists, 7 colorectal surgeons, 5 general surgeons, and 1 primary care physician. Their mean age was 61 years; 49.5% were male. In all, 21% removed all polyps during insertion, 55% removed polyps measuring less than 5 mm on insertion, and 24% removed polyps only upon withdrawal, Dr. Sanaka said.

Dr. Hewett disclosed consulting for Olympus America. Dr. Rex receives research support from Olympus America and is on their speakers bureau; he had no other relevant disclosures. Dr. Sanaka disclosed no conflicts; three of his coauthors disclosed financial relationships with Boston Scientific, Olympus America, Myriad Genetics, Pfizer, Salix Pharmaceuticals and Takeda Pharmaceuticals. Dr. Coyle reported a financial relationship with Takeda Pharmaceuticals.

CHICAGO – Same-day bundling of endoscopic procedures offers several important advantages, yet bundling was not used for 37% of procedures in a national sample of Medicare patients who had both colonoscopy and upper endoscopy within 180 days.

Moreover, the two procedures were separated from each other by a median of only 26 days, and nearly 30% of procedures that were not performed on the same day were separated by just 4 days or less.

Photo Nick Piegari/Elsevier Global Medical News

"The lack of bundling was unlikely to be explained by clinical necessity," lead investigator Dr. Hashem B. El-Serag said at the annual Digestive Disease Week. "The financial implications to the health care system and the increased adverse events in patients are likely to be large," he stated.

Although bundling is convenient for patients, efficient for providers, and offers cost savings to the health care system, there is a financial disincentive for physicians to embrace this approach.

Reimbursement by Medicare for bundled procedures occurs at a rate that is less than the sum of the two procedures when they are charged separately. For example, reimbursement for a diagnostic upper endoscopy, or esophagogastroduodenoscopy (EGD) is just $75 when bundled and $150 when not bundled, while an upper GI endoscopic biopsy is $88 bundled vs. $177 when not bundled, explained Dr. El-Serag, professor of medicine and chief of gastroenterology and hepatology at Baylor College of Medicine in Houston.

The researchers examined 2007 outpatient Medicare claims from a 5% random sample of patients who lived in one of the Surveillance, Epidemiology and End Results (SEER) database regions. They then identified 12,905 Medicare beneficiaries who underwent both a colonoscopy and EGD within 180 days of each other. Patients who were not enrolled in Medicare parts A and B or were members of an HMO were excluded.

Based on ICD-9 codes, potential clinical indications for colonoscopy included evidence of GI bleeding such as anemia, heme-positive stool, hemorrhage of the rectum and anus, and iron deficiency; colon symptoms such as abdominal mass, distention, pain or mass, anorexia, bowel obstruction, change in bowel habits, constipation, diarrhea, fecal incontinence, weight loss, and nausea and vomiting; and colon surveillance in the presence of Crohn’s disease or a personal history of colorectal cancer, colon polyps, or ulcerative colitis.

Indications for EGD included signs of GI bleeding and upper GI symptoms. The median age of the patients was 75 years, 63% were female, and 79% were white.

In all, 8,100 procedures (63%) were bundled on the same day, 2,624 (20%) were performed within 30 days of each other, and 2,181 (17%) were performed within 31-180 days of each other, Dr. El-Serag said.

Nearly 30% of the 4,805 procedures that were not bundled were performed within 4 days of each other, with another 10% performed within 12 days of each other and 5% or less performed 44 or more days apart.

"Most procedures that were not bundled were performed reasonably close to each other," he said.

There were no significant differences between the three groups of patients – those who had bundled procedures, those who had them within 30 days, and those who had them within 31-180 days – with regard to gender or age. Patients who had bundled procedures, however, were less likely to be black (7.3% for bundled vs. 10.7% within 1-30 days vs. 7.5% within 31-180 days) or to live in a metropolitan area (82% vs. 87% vs. 87%, respectively).

An indication of GI bleeding was more likely in patients who had bundling, Dr. El-Serag said. Also, patients with bundled procedures were less likely to have screening as an indication, compared with patients whose procedures were not bundled.

Limitations of the study include possible inaccuracies in coding for some of the determinants, residual confounding by uncollectible factors such as patient preference or doctor’s advice, and generalizability. Strengths of the study are its population-based design that reflects a wide array of practices, its large sample size, and its complete capture of procedures in a non-HMO population, he said.

During a discussion of the study, an attendee asked how the researchers could be certain that an upper endoscopy performed 3 weeks after a colonoscopy was done for an indication known at the time of the first procedure. Dr. El-Serag replied that, while they couldn’t be absolutely certain when the additional indication popped into the chart, the 30-day window reduced the possibility of an emergent diagnosis requiring an additional procedure in the majority of cases.

"So you can be quite safe that for anything done within 30 days of each other, there was nothing new," he said.

Another attendee asked whether physician factors such as years in practice or type of facility may have influenced the use of bundling. Dr. El-Serag said that he and his associates have not done such an analysis and are limited by the nature of the database. It was noted during the discussion, however, that some ambulatory care centers have almost a standing policy against bundling, and that large institutions have been known to get around the thorny issue of reimbursement by having two providers at the same institution bill for procedures performed on the same day.

Session cochair Dr. James M. Scheiman, professor of internal medicine at the University of Michigan Health System in Ann Arbor, said, "I was surprised it [non-bundling] was only a third, I expected it to be much higher."

Dr. El-Serag said in an interview after the presentation that he too was surprised by the results, but he expected more physicians to bundle the two procedures because patients with suspected GI disorders often need both colonoscopy and upper endoscopy.

"It begs the question that the indication was the same one and that it was just a matter of convenience, patient request, or financial disincentive," he said. "Removing the financial disincentive for physicians to bundle procedures is likely to reduce the overall costs to the health care system by saving the facility fees, anesthesia, and work days lost."

Dr. El-Serag disclosed research support and other financial relationships with Astra-Zeneca and Onyx Pharmaceuticals and consulting for Vertex Pharmaceuticals. Coauthor Dr. Gregory S. Cooper reported consulting for and serving on advisory committees/review panels for Medtronic.

CHICAGO – Same-day bundling of endoscopic procedures offers several important advantages, yet bundling was not used for 37% of procedures in a national sample of Medicare patients who had both colonoscopy and upper endoscopy within 180 days.

Moreover, the two procedures were separated from each other by a median of only 26 days, and nearly 30% of procedures that were not performed on the same day were separated by just 4 days or less.

Photo Nick Piegari/Elsevier Global Medical News

"The lack of bundling was unlikely to be explained by clinical necessity," lead investigator Dr. Hashem B. El-Serag said at the annual Digestive Disease Week. "The financial implications to the health care system and the increased adverse events in patients are likely to be large," he stated.

Although bundling is convenient for patients, efficient for providers, and offers cost savings to the health care system, there is a financial disincentive for physicians to embrace this approach.

Reimbursement by Medicare for bundled procedures occurs at a rate that is less than the sum of the two procedures when they are charged separately. For example, reimbursement for a diagnostic upper endoscopy, or esophagogastroduodenoscopy (EGD) is just $75 when bundled and $150 when not bundled, while an upper GI endoscopic biopsy is $88 bundled vs. $177 when not bundled, explained Dr. El-Serag, professor of medicine and chief of gastroenterology and hepatology at Baylor College of Medicine in Houston.

The researchers examined 2007 outpatient Medicare claims from a 5% random sample of patients who lived in one of the Surveillance, Epidemiology and End Results (SEER) database regions. They then identified 12,905 Medicare beneficiaries who underwent both a colonoscopy and EGD within 180 days of each other. Patients who were not enrolled in Medicare parts A and B or were members of an HMO were excluded.

Based on ICD-9 codes, potential clinical indications for colonoscopy included evidence of GI bleeding such as anemia, heme-positive stool, hemorrhage of the rectum and anus, and iron deficiency; colon symptoms such as abdominal mass, distention, pain or mass, anorexia, bowel obstruction, change in bowel habits, constipation, diarrhea, fecal incontinence, weight loss, and nausea and vomiting; and colon surveillance in the presence of Crohn’s disease or a personal history of colorectal cancer, colon polyps, or ulcerative colitis.

Indications for EGD included signs of GI bleeding and upper GI symptoms. The median age of the patients was 75 years, 63% were female, and 79% were white.

In all, 8,100 procedures (63%) were bundled on the same day, 2,624 (20%) were performed within 30 days of each other, and 2,181 (17%) were performed within 31-180 days of each other, Dr. El-Serag said.

Nearly 30% of the 4,805 procedures that were not bundled were performed within 4 days of each other, with another 10% performed within 12 days of each other and 5% or less performed 44 or more days apart.

"Most procedures that were not bundled were performed reasonably close to each other," he said.

There were no significant differences between the three groups of patients – those who had bundled procedures, those who had them within 30 days, and those who had them within 31-180 days – with regard to gender or age. Patients who had bundled procedures, however, were less likely to be black (7.3% for bundled vs. 10.7% within 1-30 days vs. 7.5% within 31-180 days) or to live in a metropolitan area (82% vs. 87% vs. 87%, respectively).

An indication of GI bleeding was more likely in patients who had bundling, Dr. El-Serag said. Also, patients with bundled procedures were less likely to have screening as an indication, compared with patients whose procedures were not bundled.

Limitations of the study include possible inaccuracies in coding for some of the determinants, residual confounding by uncollectible factors such as patient preference or doctor’s advice, and generalizability. Strengths of the study are its population-based design that reflects a wide array of practices, its large sample size, and its complete capture of procedures in a non-HMO population, he said.

During a discussion of the study, an attendee asked how the researchers could be certain that an upper endoscopy performed 3 weeks after a colonoscopy was done for an indication known at the time of the first procedure. Dr. El-Serag replied that, while they couldn’t be absolutely certain when the additional indication popped into the chart, the 30-day window reduced the possibility of an emergent diagnosis requiring an additional procedure in the majority of cases.

"So you can be quite safe that for anything done within 30 days of each other, there was nothing new," he said.

Another attendee asked whether physician factors such as years in practice or type of facility may have influenced the use of bundling. Dr. El-Serag said that he and his associates have not done such an analysis and are limited by the nature of the database. It was noted during the discussion, however, that some ambulatory care centers have almost a standing policy against bundling, and that large institutions have been known to get around the thorny issue of reimbursement by having two providers at the same institution bill for procedures performed on the same day.

Session cochair Dr. James M. Scheiman, professor of internal medicine at the University of Michigan Health System in Ann Arbor, said, "I was surprised it [non-bundling] was only a third, I expected it to be much higher."

Dr. El-Serag said in an interview after the presentation that he too was surprised by the results, but he expected more physicians to bundle the two procedures because patients with suspected GI disorders often need both colonoscopy and upper endoscopy.

"It begs the question that the indication was the same one and that it was just a matter of convenience, patient request, or financial disincentive," he said. "Removing the financial disincentive for physicians to bundle procedures is likely to reduce the overall costs to the health care system by saving the facility fees, anesthesia, and work days lost."

Dr. El-Serag disclosed research support and other financial relationships with Astra-Zeneca and Onyx Pharmaceuticals and consulting for Vertex Pharmaceuticals. Coauthor Dr. Gregory S. Cooper reported consulting for and serving on advisory committees/review panels for Medtronic.

CHICAGO – Same-day bundling of endoscopic procedures offers several important advantages, yet bundling was not used for 37% of procedures in a national sample of Medicare patients who had both colonoscopy and upper endoscopy within 180 days.

Moreover, the two procedures were separated from each other by a median of only 26 days, and nearly 30% of procedures that were not performed on the same day were separated by just 4 days or less.

Photo Nick Piegari/Elsevier Global Medical News

"The lack of bundling was unlikely to be explained by clinical necessity," lead investigator Dr. Hashem B. El-Serag said at the annual Digestive Disease Week. "The financial implications to the health care system and the increased adverse events in patients are likely to be large," he stated.

Although bundling is convenient for patients, efficient for providers, and offers cost savings to the health care system, there is a financial disincentive for physicians to embrace this approach.

Reimbursement by Medicare for bundled procedures occurs at a rate that is less than the sum of the two procedures when they are charged separately. For example, reimbursement for a diagnostic upper endoscopy, or esophagogastroduodenoscopy (EGD) is just $75 when bundled and $150 when not bundled, while an upper GI endoscopic biopsy is $88 bundled vs. $177 when not bundled, explained Dr. El-Serag, professor of medicine and chief of gastroenterology and hepatology at Baylor College of Medicine in Houston.

The researchers examined 2007 outpatient Medicare claims from a 5% random sample of patients who lived in one of the Surveillance, Epidemiology and End Results (SEER) database regions. They then identified 12,905 Medicare beneficiaries who underwent both a colonoscopy and EGD within 180 days of each other. Patients who were not enrolled in Medicare parts A and B or were members of an HMO were excluded.

Based on ICD-9 codes, potential clinical indications for colonoscopy included evidence of GI bleeding such as anemia, heme-positive stool, hemorrhage of the rectum and anus, and iron deficiency; colon symptoms such as abdominal mass, distention, pain or mass, anorexia, bowel obstruction, change in bowel habits, constipation, diarrhea, fecal incontinence, weight loss, and nausea and vomiting; and colon surveillance in the presence of Crohn’s disease or a personal history of colorectal cancer, colon polyps, or ulcerative colitis.

Indications for EGD included signs of GI bleeding and upper GI symptoms. The median age of the patients was 75 years, 63% were female, and 79% were white.

In all, 8,100 procedures (63%) were bundled on the same day, 2,624 (20%) were performed within 30 days of each other, and 2,181 (17%) were performed within 31-180 days of each other, Dr. El-Serag said.

Nearly 30% of the 4,805 procedures that were not bundled were performed within 4 days of each other, with another 10% performed within 12 days of each other and 5% or less performed 44 or more days apart.

"Most procedures that were not bundled were performed reasonably close to each other," he said.

There were no significant differences between the three groups of patients – those who had bundled procedures, those who had them within 30 days, and those who had them within 31-180 days – with regard to gender or age. Patients who had bundled procedures, however, were less likely to be black (7.3% for bundled vs. 10.7% within 1-30 days vs. 7.5% within 31-180 days) or to live in a metropolitan area (82% vs. 87% vs. 87%, respectively).

An indication of GI bleeding was more likely in patients who had bundling, Dr. El-Serag said. Also, patients with bundled procedures were less likely to have screening as an indication, compared with patients whose procedures were not bundled.

Limitations of the study include possible inaccuracies in coding for some of the determinants, residual confounding by uncollectible factors such as patient preference or doctor’s advice, and generalizability. Strengths of the study are its population-based design that reflects a wide array of practices, its large sample size, and its complete capture of procedures in a non-HMO population, he said.

During a discussion of the study, an attendee asked how the researchers could be certain that an upper endoscopy performed 3 weeks after a colonoscopy was done for an indication known at the time of the first procedure. Dr. El-Serag replied that, while they couldn’t be absolutely certain when the additional indication popped into the chart, the 30-day window reduced the possibility of an emergent diagnosis requiring an additional procedure in the majority of cases.

"So you can be quite safe that for anything done within 30 days of each other, there was nothing new," he said.

Another attendee asked whether physician factors such as years in practice or type of facility may have influenced the use of bundling. Dr. El-Serag said that he and his associates have not done such an analysis and are limited by the nature of the database. It was noted during the discussion, however, that some ambulatory care centers have almost a standing policy against bundling, and that large institutions have been known to get around the thorny issue of reimbursement by having two providers at the same institution bill for procedures performed on the same day.

Session cochair Dr. James M. Scheiman, professor of internal medicine at the University of Michigan Health System in Ann Arbor, said, "I was surprised it [non-bundling] was only a third, I expected it to be much higher."

Dr. El-Serag said in an interview after the presentation that he too was surprised by the results, but he expected more physicians to bundle the two procedures because patients with suspected GI disorders often need both colonoscopy and upper endoscopy.

"It begs the question that the indication was the same one and that it was just a matter of convenience, patient request, or financial disincentive," he said. "Removing the financial disincentive for physicians to bundle procedures is likely to reduce the overall costs to the health care system by saving the facility fees, anesthesia, and work days lost."

Dr. El-Serag disclosed research support and other financial relationships with Astra-Zeneca and Onyx Pharmaceuticals and consulting for Vertex Pharmaceuticals. Coauthor Dr. Gregory S. Cooper reported consulting for and serving on advisory committees/review panels for Medtronic.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – The recommended 5-year interval between screening sigmoidoscopies probably cannot be safely extended, according to an analysis of data on more than 70,000 enrollees of Kaiser Permanente of Northern California.

"We found that rates of colorectal cancer are low for at least 10 years after a negative sigmoidoscopy," reported Dr. Vincent P. Doria-Rose of Kaiser Permanente in Oakland. "But there may be consequences to waiting 10 years between endoscopies," he said at the annual Digestive Disease Week.

Current screening guidelines recommend a 10-year interval for colonoscopy and a 5-year interval for sigmoidoscopy. Prior investigations have suggested that there is a long duration of low risk for colorectal cancer (CRC) after endoscopy – up to 20 years in some series – but these studies have been limited. For example, many rely on patient self-reports, and others are case-control studies, he said.

Dr. Doria-Rose and his colleagues analyzed data from the colorectal cancer prevention program at Kaiser Permanente, through which individuals with an average risk for CRC underwent screening sigmoidoscopy once every 10 years starting at age 50. The study evaluated CRC incidence after 10.5 years of follow-up in persons screened between 1994 and 1996.

The evaluable population included 72,483 individuals with negative results on screening and excluded persons with a personal history of colorectal polyps, CRC or inflammatory bowel disease, or a high-risk family history of CRC. Of the study population, 50% were female, 51% were at least 60 years old, and 65% were white.

Within 10.5 years of index sigmoidoscopy, 103 cases of distal CRC (rectum and sigmoid) were diagnosed, as were 333 cases of proximal CRCs. The incidence rates per 100,000 person-years of both proximal and distal CRC increased over time, but did so especially during the second half of the interval, the study found.

The mean incidence rate of distal CRC during years 6-10 was approximately twice as high as that in years 1-5. The mean incidence rates were 28/100,000 person-years for the second half of the screening interval, compared with a rate of 13 during the first 5 years, for a difference of 15 cases per 100,000 person-years, Dr. Doria-Rose reported.

The rate ratio (RR) was 2.1 for all tumors diagnosed after 6 years compared with years 1-5. By age, the RR was 1.1 for those younger than 60 and 2.5 for those aged 60 and older.

The standardized incidence ratio (SIR) in the distal colon increased gradually from 0.40/100,000 in the first year post screening to 0.49 in the 10th year. For proximal cancers, increasing SIRs were due mostly to the aging of the population, and there was no clear increase over time, with a mean SIR of 0.75 for the entire follow-up period.

By subgroup analyses, the results of the current study were consistent, except for the age group that was younger than age 60 years at baseline, who experienced no increase in risk over the second half of follow-up, he said.

"The incidence rates of distal CRC increased considerably in years 6 and up as compared to that in years 1 through 5," he noted, "but remained low for the entire follow-up period."

He explained that the incidence rate in the current study is lower than has been observed in the SEER (Surveillance, Epidemiology, and End Results) population of the San Francisco Bay area, a finding that could be due to patient selection. The current study involved an insured population that presented for screening and whose lifestyle and behaviors would reduce their inherent risk, he suggested.

"The rate is low for 10 years of follow-up, compared with the SEER rate, but there was still a doubling in the second half," Dr. Doria-Rose emphasized.

"These data do not suggest that there is one obvious, clear-cut interval for screening sigmoidoscopy," he concluded, "and they provide no information regarding the duration of [a low-risk period] following the endoscopic examination of the right colon."

He added that to evaluate the relative benefits of sigmoidoscopy every 5 years, versus colonoscopy every 10 years, similar analyses in large cohorts of individuals screened by colonoscopy will be required.

Dr. Doria-Rose reported no relevant financial disclosures.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Phase III data from a randomized, placebo-controlled trial indicate that the novel agent teduglutide reduces the need for parenteral support in patients with short-bowel syndrome.

At week 20 and week 24, 63% of patients who were randomized to teduglutide (Gattex) achieved at least a 20% reduction in the volume of parenteral fluid required, compared with baseline. Only 30% of patients receiving the placebo achieved this degree of reduction in their parenteral nutrition needs (P = .002), said lead author Dr. Palle B. Jeppesen during a late-breaking abstract session at the annual Digestive Disease Week.

Short-bowel syndrome (SBS) results from removal of the small intestine because of Crohn’s disease, cancer, or other conditions, and is characterized by malabsorption of nutrients, fluids, and electrolytes, as well as diarrhea. An estimated 10,000-15,000 SBS patients in North America are dependent on parenteral nutrition (PN) for their fluid and nutritional needs, at an annual cost that can exceed $100,000 per patient.

"This has a tremendous impact on their life situation, and of course, what we would like to do is provide them with some treatment, getting them off their parental support," said Dr. Jeppesen, with the Copenhagen University Hospital.

Teduglutide is a recombinant analogue of glucagonlike peptide 2, a peptide that enhances intestinal absorption by thickening the intestinal mucosa and increasing villus height and crypt depth.

Teduglutide has been designated an orphan drug for the treatment of SBS by the Food and Drug Administration and the European Medicines Agency. An application was submitted in March to market teduglutide with the brand name Revestive in Europe as a once-daily subcutaneous treatment for SBS, with a similar application under the brand name Gattex expected later this year in the United States, according to study sponsor NPS Pharmaceuticals. In the STEPS (Study of Teduglutide in PN-Dependent Short-Bowel Syndrome) trial, patients had at least 12 continuous months of PN support prior to enrollment; required PN at least three times weekly to meet caloric, fluid, or electrolyte needs; and had a body mass index of at least 15 kg/m².

After an initial 30-day stabilization period, 86 patients were randomized to subcutaneous teduglutide 0.05 mg/kg or placebo once daily for 24 weeks. One patient in the teduglutide group was randomized in error and not treated.

At baseline, the teduglutide and placebo groups were similar in age (51 years vs. 50 years), weight (63 kg vs. 62 kg), estimated mean small bowel length (84 cm vs. 69 cm), and mean baseline liters of intravenous PN fluid per week (12.5 L vs. 13.4 L).

At week 24, the mean absolute reduction in PN fluid required by the patient was 4.4 L in the teduglutide group vs.2.3 L in the placebo group (P less than .001), Dr. Jeppesen said.

Significantly more patients who were treated with teduglutide had one or more additional days off parenteral infusions (54% vs. 23%; P = .0047). "Having days off parenteral support is an important issue for their social life," he said.

During a discussion of the study, an attendee asked whether patients will be able to take teduglutide cyclically or will need the drug continually for the rest of their lives. Dr. Jeppesen replied that "it is going to be like treating diabetes. It only works when you give them insulin, and it’s the same case with this drug. It works as long as you give it, and when you take it off they go back to their baseline."

Audience members then asked whether there are any long-term effects of teduglutide, particularly in light of concerns that were raised early on about tumor promotion, which have been reportedly addressed by NPS Pharmaceuticals. Dr. Jeppesen said there is no reason to expect any problems and that the drug has a very good safety profile.

Another attendee asked whether teduglutide is likely to be helpful for unstable patients, and Dr. Jeppesen responded that yes, this is likely.

The most common treatment-emergent adverse events in the teduglutide and placebo groups were abdominal pain (31% vs. 23%), nausea (29% vs. 19%), and stoma complications (24% vs. 7%). Physicians should explain to teduglutide patients that abdominal discomfort resulting from growth of the bowel is to be expected, Dr. Jeppesen said.

Three patients discontinued teduglutide; the reasons were abdominal distention, abdominal pain, and investigator decision. Four patients discontinued placebo treatment. There were no deaths in the study.

Dr. Jeppesen disclosed consulting for the study sponsor, NPS Pharmaceuticals.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – Among older patients, the rate of new or missed left-sided colorectal cancers quadrupled with flexible sigmoidoscopy compared with colonoscopy in a retrospective analysis of 25,541 cases.

The overall interval colorectal cancer (CRC) rate, defined as colorectal cancer diagnosed 6-36 months after a lower endoscopy, was 11.7% after flexible sigmoidoscopy vs. 2.6% after colonoscopy, Dr. Yize Richard Wang reported in a late-breaking abstract session at the annual Digestive Disease Week.

The rate of interval CRCs was higher after sigmoidoscopy than colonoscopy in all locations: the descending colon (18.7% vs. 3.3%), rectum (12.5% vs. 2.7%), left colon combined (11.7% vs. 2.6%), sigmoid colon (11.3% vs. 2.4%) and rectosigmoid junction (8% vs. 2.2%).

"Despite the imperfections of colonoscopy, it remains the gold standard for colorectal cancer detection and prevention," concluded Dr. Wang, a fellow with the Mayo Clinic in Jacksonville, Fla.

Although some news reports hailed the study as a boon for colonoscopy, it is unlikely to resolve the long-standing debate over which screening method is optimal. Sigmoidoscopy requires no sedation and less time and bowel preparation for the patient, but cannot visualize the entire colon. Colonoscopy typically requires sedation and has a higher perforation rate, but allows for examination of the entire colon and removal of any detected polyps. Still, these benefits have not translated into an unequivocal reduction in the incidence and mortality from cancer beyond the reach of sigmoidoscopy.

A recent commentary on colonoscopy vs. sigmoidoscopy screening (JAMA 2010;304:461-2) states that if "further evidence supports a lack of efficacy of colonoscopy for reducing incidence and mortality for right-sided colorectal cancer, the medical community should be prepared to consider returning to sigmoidoscopy for endoscopic screening of average-risk individuals."

Just 2 years ago at the same meeting, researchers with the Norwegian Colorectal Cancer Prevention Centre reported that the use of flexible sigmoidoscopy among 55,736 patients aged 55-64 years reduced colorectal cancer mortality 27% after 6 years, compared with no screening. The trend was not statistically significant, but when the researchers limited the analysis to patients who were randomized and actually underwent flexible sigmoidoscopy, there was a significant 59% reduction in total colorectal cancer mortality and significant 76% reduction in rectosigmoid cancer (BMJ 2009 May 29;338:b1846 [doi:10.1136/bmj.b1846]).

The current study included 25,541 patients 67 years and older at the time of a lower endoscopy during 1988-2005, who were subsequently diagnosed within 36 months with CRC distal to the splenic flexure. All but 841 of the 25,541 cases were detected within the first 6 months.

The patients were identified in the Surveillance, Epidemiology, and End Results–Medicare linked database. Exclusion criteria included participation in an HMO, no Medicare Part B coverage for the 24 months preceding the exam, inflammatory bowel disease, and a history of polyps or family history of colorectal cancer.

Compared with the colonoscopy group, the flexible sigmoidoscopy group was slightly older (78 vs. 77 years), included more women (53% vs. 50%) and fewer nonwhites (14% vs. 16%), lived in ZIP codes with higher income/education (no data given), and were more likely to be seen by nongastroenterologists (66% vs. 33%), Dr. Wang said.

In multivariate logistic analysis, women were at 15% higher risk of interval CRC (odds ratio 1.15), while undergoing an inpatient procedure reduced the risk by 47% (OR 0.53).

The odds ratio for an interval CRC with flexible sigmoidoscopy was 4.0 (95% confidence interval 3.51-4.55).

During a discussion of the study, attendees asked whether detection rates were different among gastroenterologists and nongastroenterologists. Dr. Wang replied that there was no difference (OR 1.09 for nongastroenterologists), but that a difference was observed in the right-side colon in another study presented at the meeting.

Dr. Wang pointed out that the retrospective study had several limitations including the inability to determine the indication for, or findings of, the lower endoscopy. It also does not apply to patients undergoing screening colonoscopy for detection and removal of polyps, and does not reflect recent advances in endoscopy such as high-definition colonoscopy.

"Whether our findings reflect differences in bowel preparation quality, lack of sedation, or depth reached during sigmoidoscopy, warrants future research," he said.

Two independent randomized trials of screening colonoscopy are ongoing (NCT00906997 and NCT00883792), but results are not expected until 2021 and 2026.

Dr. Wang disclosed no relevant conflicts of interest.

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.

CHICAGO – A retrospective chart review of 1,218 cases at one institution suggests that nearly two-thirds of the colorectal cancers that occur in the interval between colonoscopies are lesions that were missed or incompletely removed during the previous colonoscopy.

"Operator-dependant variability with regards to first detection of colorectal cancer lesions, and effectiveness of treatment, may be a critical factors," according to lead author Chantal le Clercq, a medical student at Maastricht (the Netherlands) University Medical Center, who presented the data at the annual Digestive Disease Week.

All clinical and pathological records of all 1,218 patients diagnosed with colorectal cancer at Maastricht University Medical Center from Jan. 1, 2001 to Dec. 31, 2010 were reviewed. The patient population was 55% men and the mean age was 70 years. Patients with hereditary colorectal cancer, irritable bowel disease, or a previous history of colorectal cancer were excluded from the data analysis.

Cases also were excluded from analysis if records noted incomplete visualization of the colon, poor bowel preparation, or inadequate surveillance according to Dutch guidelines.

Interval colorectal cancers were defined as cancers occurring in the colon and rectum within 5 years of an index colonoscopy. All colorectal cancers were classified as either flat or protruded, and proximal or distal to the splenic flexure.

Interval colorectal cancers were defined as those developing from lesions missed because of a subtle microscopic appearance, such as flat tumors or those smaller than 1 cm, or from those incompletely removed in a previous polypectomy. When neither definition fit, the cause was ruled unclear.

Around 3% (39) of all colorectal cancers developed in patients who had a colonoscopy within the previous 5 years, said Ms. le Clercq. About one-third (11) were excluded from the analysis due to incomplete visualization or inadequate surveillance. About 2% (28) were interval colorectal cancers, which occurred mainly in men (71%) around 70 years old. On average, these cancers were diagnosed 26 months after the index colonoscopy.

The interval colorectal cancers were significantly smaller than noninterval cancers. Nearly 12% were smaller than 1 cm, 19% were 1-2 cm, and the remaining 69% were larger than 2 cm.

Interval colorectal cancers were more likely to be flat lesions than were non–interval colorectal cancers. The Tumor Node Metastasis (TNM) stage and histology were virtually identical. In both cases, more than 70% of procedures were performed by endoscopists.

Multiple logistic regression analysis, adjusted for age and sex, revealed that interval colorectal cancers were more often small (2.7 cm vs. 3.9 cm; odds ratio, 0.82; 95% confidence interval, 0.69-0.97; P = .020). They were more often flat than protruded (48% vs. 21%; OR, 3.75; 95% CI, 1.73-8.13; P = .001). They were more often located in the proximal than the distal colon (70% vs. 33%; OR, 5.07; 95% CI, 2.18-11.8; P less than .001).

"We found that 54% of cases (n = 15) could be explained by more subtle microscopic appearance. So, these tumors were less than 1 cm in size, or they had a flat appearance, and therefore, these could be explained as potentially missed lesions," said Ms. le Clercq.

Of the remaining 13 cases, 36% (n = 10) had no clear explanation, and nearly 11% (n = 3) could be attributed to incomplete polypectomy, because "they developed in the same [anatomical segment] as a previous polypectomy and therefore could be explained by potentially incomplete removed lesion," said Ms. le Clercq.

Ms. le Clercq said that 2.2% (1 of 45) of all colorectal cancers diagnosed at her hospital over the past 10 years were interval colorectal cancers. Around 64% of these lesions were related either to lesions that were overlooked, small, or flat, or were incompletely removed.

"These data highlight the need to train practicing endoscopists in the accurate detection and effective treatment of colorectal lesions, to prevent interval colorectal cancers in everyday practice," she said.

Ms. le Clercq disclosed no financial relationship with a commercial interest.