Pancreaticobiliary potpourri

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The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”

Dr. Todd H. Baron
Dr. Todd H. Baron
There were many useful take-home points from the three lectures. Dr. Chari pointed out that, while most incidentally identified pancreatic cysts are clinically innocuous, it is often difficult to provide cost-effective care for patients with this entity. There are myriad pathologies in the differential diagnosis of the incidental cyst. Algorithms are available to differentiate benign cysts from those that are malignant or premalignant. Imaging features on CT and/or MRI can be useful, as can endoscopic ultrasound (EUS). The latter can allow for aspiration of fluid for analysis and provide tissue in some cases.

 

Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.

I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.

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The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”

Dr. Todd H. Baron
Dr. Todd H. Baron
There were many useful take-home points from the three lectures. Dr. Chari pointed out that, while most incidentally identified pancreatic cysts are clinically innocuous, it is often difficult to provide cost-effective care for patients with this entity. There are myriad pathologies in the differential diagnosis of the incidental cyst. Algorithms are available to differentiate benign cysts from those that are malignant or premalignant. Imaging features on CT and/or MRI can be useful, as can endoscopic ultrasound (EUS). The latter can allow for aspiration of fluid for analysis and provide tissue in some cases.

 

Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.

I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.

The session at the annual Digestive Disease Week entitled Pancreaticobiliary Potpourri encompassed three lectures. Suresh Chari, MD, from Mayo Clinic, Rochester, Minn., presented a lecture titled, “The cystic pancreas.” Gregory Gores, MD, AGAF, also of Mayo Clinic presented a lecture on “Managing the possibly malignant biliary stricture.” Finally, I, Todd H. Baron, MD, from the University of North Carolina at Chapel Hill delivered a lecture titled, “Preventing and managing complications of acute pancreatitis.”

Dr. Todd H. Baron
Dr. Todd H. Baron
There were many useful take-home points from the three lectures. Dr. Chari pointed out that, while most incidentally identified pancreatic cysts are clinically innocuous, it is often difficult to provide cost-effective care for patients with this entity. There are myriad pathologies in the differential diagnosis of the incidental cyst. Algorithms are available to differentiate benign cysts from those that are malignant or premalignant. Imaging features on CT and/or MRI can be useful, as can endoscopic ultrasound (EUS). The latter can allow for aspiration of fluid for analysis and provide tissue in some cases.

 

Dr. Gores relayed that there are a variety of etiologies of biliary strictures. Discerning benign from malignant causes involves the use of cross-sectional imaging, PET-CT, serum tests, and endoscopy to include endoscopic retrograde cholangiopancreatography (ERCP) and EUS. IgG4, or autoimmune disease, is an important treatable cause of biliary obstruction. The diagnosis requires a high index of suspicion. Notably, an elevated serum IgG4 level can be seen in patients with cholangiocarcinoma. Fluorescence in situ hybridization (FISH) applied to biliary brush samples at the time of cytologic evaluation has been shown to markedly improve the sensitivity, compared with standard brush cytology. Cholangioscopy with targeted biopsies has been shown to have a sensitivity of 66% and specificity of 97%.

I emphasized the importance of preventing pancreatitis by careful selection of patients for ERCP, by limiting contrast injection during ERCP, and by the use of rectally administered nonsteroidal anti-inflammatory agents at the time of ERCP. Prevention of complications after onset of ERCP is the focus in patients with clinically severe acute pancreatitis, which is usually the result of pancreatic and/or peripancreatic necrosis. Early management consists of prompt and appropriate volume resuscitation, with recent evidence showing Lactated Ringer’s solution being superior to saline. Routine administration of antibiotics is not recommended, but early enteral feeding is recommended. Finally, interventions should be delayed as long as possible with minimally invasive techniques, including endoscopic drainage for walled-off pancreatic necrosis favored over traditional open procedures.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016. Dr. Baron is professor of medicine and director of advanced therapeutic endoscopy in the division of gastroenterology and hepatology in the school of medicine at the University of North Carolina at Chapel Hill. He has consulted and been a speaker for BSCI, Cook Endoscopy, and Olympus; and consulted for W.L. Gore.

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Colon cancer

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Colorectal cancer (CRC) screening has become a focal point of the practice of gastroenterology. Successful screening leads to a reduction in cancer mortality and is one of the most impactful means by which we improve population health.

Rick Boland, MD, of the Baylor Center of Gastrointestinal Cancer Research in Dallas reminded us at the annual Digestive Disease Week that carcinogenesis in colorectal cancer is a multistep process and described several pathways of which clinicians should be aware. Germline mutations (inherited) vs. somatic mutations (acquired) may be driver mutations that confer selection advantage and become targets for therapy in contrast to passenger mutations that are not mechanistic targets. Germline mutations should be considered when there is a family history of CRC, especially in a young patient, and are characteristic of familial adenomatous polyposis (APC), attenuated polyposis (MYH-MUTYH), and nonadenomatous polyposis syndromes such as Peutz-Jeghers (STK11).

Dr. John M. Inadomi
Dr. John M. Inadomi

Microsatellite instability is an alternative pathway to cancer. Hereditary nonpolyposis colorectal cancer (Lynch syndrome) is representative of this pathway with common abnormalities in mismatch repair genes such as MLH1, MSH2, MSH6, or PMS2. Lynch syndrome patients are BRAF and CIMP negative. This is in contrast to a more recent pathway to cancer that arises from sessile serrated polyps that also display microsatellite instability, but are BRAF and CIMP positive.

The clinical importance of understanding the pathway through which cancer develops in an individual patient is that depending on the mechanism of tumorigenesis, different treatment strategies can prevent or treat cancer. For example, exciting novel therapies are being developed for microsatellite unstable cancers using immune checkpoint inhibitors. Aspirin can reduce CRC mortality, especially tumors that overexpress COX2 or harbor PIK3CA mutations, and have demonstrated benefit even postoperatively in patients receiving surgical resection of CRC.

I gave a talk focused on current guidelines for reducing mortality among individuals at average risk for developing CRC. The U.S. Preventive Services Task Force updated their recommendations this year and chose to focus on highlighting the importance of CRC screening between the ages of 50 and 75 years, tailored screening for those between the ages of 76 and 85 years, and stopping screening after age 85 years. However, the statement does not recommend specific tests and instead lists competing strategies of annual fecal immunochemical test (FIT) or highly sensitive fecal occult blood test (FOBT) with or without flexible sigmoidoscopy every 10 years, flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, CT colonography every 5 years, and FIT-DNA every 1 or 3 years. The FIT-DNA adds a separate FIT to a stool exam for KRAS mutations, NDRG4 and BMP3 methylation, and beta-actin. There are no studies to determine whether CRC mortality is reduced, but one study demonstrated a higher sensitivity for CRC with the combined FIT-DNA, compared with FIT alone, but a lower specificity. The FDA also recently approved a blood-based CRC screening test that detects circulating methylated septin 9 gene DNA. Septin 9 is a gene that codes for GTP-binding protein and acts as a tumor suppressor that can be inactivated by methylation.

Irrespective of which strategy is pursued, colonoscopy is the final common pathway. Quality is important because there remains a disappointing rate of CRC after colonoscopy. Prior work has demonstrated significant differences in the adenoma detection rate (ADR) between endoscopists in the same practice. A recent Kaiser study found that for every 1% increase in the ADR there is a 3% decrease in the rate of cancer developing after colonoscopy.

Disruptive technology is emerging that may displace gastroenterologists from primary endoscopic screening. A self-propelled disposable colonoscope (Aer-O-Scope) has been developed that uses pneumatic pressure to advance a tethered camera through the colonic lumen guided by a joystick. Sedation is not required and the device does not need manual advancement, facilitating use by nongastroenterologists.

Uri Ladabaum, MD, of Stanford (Calif.) University presented the clinical impact of screening for hereditary and familial CRC. Lynch syndrome is characterized by a family history of cancer in at least three individuals spanning at least two generations including one with early cancer development. He reminded us that Lynch syndrome cancers are not limited to CRC but also include uterine, ovarian, gastric, small intestinal, urinary, biliary, pancreatic, and neurologic tumors. Microsatellite instability is likely present, mismatch repair gene abnormalities should be sought, and screening should include colonoscopy every 1-2 years. Aspirin chemoprophylaxis should be recommended, as should prophylactic hysterectomy and oophorectomy among affected women due to the uterine and ovarian cancer risk.

Polyposis syndromes constitute a separate group of hereditary cancers that includes familial adenomatous polyposis (FAP) arising from defects in the APC gene that may present as florid or attenuated FAP, and MYH-associated polyposis. If a patient presents with more than 10 adenomas, a polyposis syndrome should be considered. More rare syndromes include Cowden, juvenile polyposis, and Peutz-Jeghers.

 

 

Douglas Rex, MD, of Indiana University, Indianapolis, provided an array of highly clinically relevant tips to improve screening colonoscopy quality, which has been shown to reduce CRC mortality. Some of the basic concepts include using split-dose preparations and high-definition endoscopes, measuring and reporting adenoma detection rates, and using water immersion with carbon dioxide instead of air insufflation. Special attention was given to the diagnosis and removal of sessile lesions of the colon. Dr. Rex revealed many of his “tricks” to achieving high-quality colonoscopy, which include retroflexion to access polyps behind folds, using a stiff snare, and attaching a cap to the end of the colonoscope in order to facilitate visualization of polyps and assist in the mucosal resection of sessile lesions. Dr. Rex also presented data to support his recommendation to use “avulsion” with cold snare and forceps while limiting coagulative ablation for residual polyp tissue.

Finally, Rajeev Jain, MD, of Dallas presented the rapidly evolving area of reimbursement reform including the Medicare Access and CHIP Reauthorization Act (MACRA) that is driving payment away from fee-for-service and towards bundled payments, accountable care networks, and patient-centered medical homes. Key to this reform is the documentation and reporting of quality for procedural and cognitive patient encounters. There are limited performance measures specific to gastroenterology and hepatology, which currently include measures to both document appropriate CRC screening and reduce colonoscopy overuse, inflammatory bowel disease management, and hepatitis C management. However, there are many cost-cutting measures that can also be reported by gastroenterologists to fulfill these requirements. The Physician Quality Reporting System requires at least nine measures for at least 50% of Medicare patients in order to avoid penalties. It is not enough to track and document quality measures – results must also be reported through CMS-approved entities called qualified clinical data registries.

Dr. Jain described the movement toward payment bundles in which a single reimbursement is provided for services rendered by all providers and sites across a single episode of care. Screening colonoscopy was used as an example of how this could impact gastroenterology: a single payment would be provided for the preprocedure evaluation and education, the procedure itself (including endoscopy, anesthesia, pathology, facility), and postprocedure follow-up. Additional payments would not be provided for additional services such as repeating the colonoscopy because of a poor preparation or to treat postpolypectomy bleeding. Overall, health care reimbursement is moving to recognize value (quality/cost), reduce variation in care, and transfer more of the financial risk to health care providers and systems.

Dr. Inadomi, division of gastroenterology, department of medicine, University of Washington School of Medicine, department of health services, University of Washington School of Public Health, Seattle. He is on the clinical advisory committee for ChemImage and on the scientific advisory board for Epigenomics.

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Colorectal cancer (CRC) screening has become a focal point of the practice of gastroenterology. Successful screening leads to a reduction in cancer mortality and is one of the most impactful means by which we improve population health.

Rick Boland, MD, of the Baylor Center of Gastrointestinal Cancer Research in Dallas reminded us at the annual Digestive Disease Week that carcinogenesis in colorectal cancer is a multistep process and described several pathways of which clinicians should be aware. Germline mutations (inherited) vs. somatic mutations (acquired) may be driver mutations that confer selection advantage and become targets for therapy in contrast to passenger mutations that are not mechanistic targets. Germline mutations should be considered when there is a family history of CRC, especially in a young patient, and are characteristic of familial adenomatous polyposis (APC), attenuated polyposis (MYH-MUTYH), and nonadenomatous polyposis syndromes such as Peutz-Jeghers (STK11).

Dr. John M. Inadomi
Dr. John M. Inadomi

Microsatellite instability is an alternative pathway to cancer. Hereditary nonpolyposis colorectal cancer (Lynch syndrome) is representative of this pathway with common abnormalities in mismatch repair genes such as MLH1, MSH2, MSH6, or PMS2. Lynch syndrome patients are BRAF and CIMP negative. This is in contrast to a more recent pathway to cancer that arises from sessile serrated polyps that also display microsatellite instability, but are BRAF and CIMP positive.

The clinical importance of understanding the pathway through which cancer develops in an individual patient is that depending on the mechanism of tumorigenesis, different treatment strategies can prevent or treat cancer. For example, exciting novel therapies are being developed for microsatellite unstable cancers using immune checkpoint inhibitors. Aspirin can reduce CRC mortality, especially tumors that overexpress COX2 or harbor PIK3CA mutations, and have demonstrated benefit even postoperatively in patients receiving surgical resection of CRC.

I gave a talk focused on current guidelines for reducing mortality among individuals at average risk for developing CRC. The U.S. Preventive Services Task Force updated their recommendations this year and chose to focus on highlighting the importance of CRC screening between the ages of 50 and 75 years, tailored screening for those between the ages of 76 and 85 years, and stopping screening after age 85 years. However, the statement does not recommend specific tests and instead lists competing strategies of annual fecal immunochemical test (FIT) or highly sensitive fecal occult blood test (FOBT) with or without flexible sigmoidoscopy every 10 years, flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, CT colonography every 5 years, and FIT-DNA every 1 or 3 years. The FIT-DNA adds a separate FIT to a stool exam for KRAS mutations, NDRG4 and BMP3 methylation, and beta-actin. There are no studies to determine whether CRC mortality is reduced, but one study demonstrated a higher sensitivity for CRC with the combined FIT-DNA, compared with FIT alone, but a lower specificity. The FDA also recently approved a blood-based CRC screening test that detects circulating methylated septin 9 gene DNA. Septin 9 is a gene that codes for GTP-binding protein and acts as a tumor suppressor that can be inactivated by methylation.

Irrespective of which strategy is pursued, colonoscopy is the final common pathway. Quality is important because there remains a disappointing rate of CRC after colonoscopy. Prior work has demonstrated significant differences in the adenoma detection rate (ADR) between endoscopists in the same practice. A recent Kaiser study found that for every 1% increase in the ADR there is a 3% decrease in the rate of cancer developing after colonoscopy.

Disruptive technology is emerging that may displace gastroenterologists from primary endoscopic screening. A self-propelled disposable colonoscope (Aer-O-Scope) has been developed that uses pneumatic pressure to advance a tethered camera through the colonic lumen guided by a joystick. Sedation is not required and the device does not need manual advancement, facilitating use by nongastroenterologists.

Uri Ladabaum, MD, of Stanford (Calif.) University presented the clinical impact of screening for hereditary and familial CRC. Lynch syndrome is characterized by a family history of cancer in at least three individuals spanning at least two generations including one with early cancer development. He reminded us that Lynch syndrome cancers are not limited to CRC but also include uterine, ovarian, gastric, small intestinal, urinary, biliary, pancreatic, and neurologic tumors. Microsatellite instability is likely present, mismatch repair gene abnormalities should be sought, and screening should include colonoscopy every 1-2 years. Aspirin chemoprophylaxis should be recommended, as should prophylactic hysterectomy and oophorectomy among affected women due to the uterine and ovarian cancer risk.

Polyposis syndromes constitute a separate group of hereditary cancers that includes familial adenomatous polyposis (FAP) arising from defects in the APC gene that may present as florid or attenuated FAP, and MYH-associated polyposis. If a patient presents with more than 10 adenomas, a polyposis syndrome should be considered. More rare syndromes include Cowden, juvenile polyposis, and Peutz-Jeghers.

 

 

Douglas Rex, MD, of Indiana University, Indianapolis, provided an array of highly clinically relevant tips to improve screening colonoscopy quality, which has been shown to reduce CRC mortality. Some of the basic concepts include using split-dose preparations and high-definition endoscopes, measuring and reporting adenoma detection rates, and using water immersion with carbon dioxide instead of air insufflation. Special attention was given to the diagnosis and removal of sessile lesions of the colon. Dr. Rex revealed many of his “tricks” to achieving high-quality colonoscopy, which include retroflexion to access polyps behind folds, using a stiff snare, and attaching a cap to the end of the colonoscope in order to facilitate visualization of polyps and assist in the mucosal resection of sessile lesions. Dr. Rex also presented data to support his recommendation to use “avulsion” with cold snare and forceps while limiting coagulative ablation for residual polyp tissue.

Finally, Rajeev Jain, MD, of Dallas presented the rapidly evolving area of reimbursement reform including the Medicare Access and CHIP Reauthorization Act (MACRA) that is driving payment away from fee-for-service and towards bundled payments, accountable care networks, and patient-centered medical homes. Key to this reform is the documentation and reporting of quality for procedural and cognitive patient encounters. There are limited performance measures specific to gastroenterology and hepatology, which currently include measures to both document appropriate CRC screening and reduce colonoscopy overuse, inflammatory bowel disease management, and hepatitis C management. However, there are many cost-cutting measures that can also be reported by gastroenterologists to fulfill these requirements. The Physician Quality Reporting System requires at least nine measures for at least 50% of Medicare patients in order to avoid penalties. It is not enough to track and document quality measures – results must also be reported through CMS-approved entities called qualified clinical data registries.

Dr. Jain described the movement toward payment bundles in which a single reimbursement is provided for services rendered by all providers and sites across a single episode of care. Screening colonoscopy was used as an example of how this could impact gastroenterology: a single payment would be provided for the preprocedure evaluation and education, the procedure itself (including endoscopy, anesthesia, pathology, facility), and postprocedure follow-up. Additional payments would not be provided for additional services such as repeating the colonoscopy because of a poor preparation or to treat postpolypectomy bleeding. Overall, health care reimbursement is moving to recognize value (quality/cost), reduce variation in care, and transfer more of the financial risk to health care providers and systems.

Dr. Inadomi, division of gastroenterology, department of medicine, University of Washington School of Medicine, department of health services, University of Washington School of Public Health, Seattle. He is on the clinical advisory committee for ChemImage and on the scientific advisory board for Epigenomics.

Colorectal cancer (CRC) screening has become a focal point of the practice of gastroenterology. Successful screening leads to a reduction in cancer mortality and is one of the most impactful means by which we improve population health.

Rick Boland, MD, of the Baylor Center of Gastrointestinal Cancer Research in Dallas reminded us at the annual Digestive Disease Week that carcinogenesis in colorectal cancer is a multistep process and described several pathways of which clinicians should be aware. Germline mutations (inherited) vs. somatic mutations (acquired) may be driver mutations that confer selection advantage and become targets for therapy in contrast to passenger mutations that are not mechanistic targets. Germline mutations should be considered when there is a family history of CRC, especially in a young patient, and are characteristic of familial adenomatous polyposis (APC), attenuated polyposis (MYH-MUTYH), and nonadenomatous polyposis syndromes such as Peutz-Jeghers (STK11).

Dr. John M. Inadomi
Dr. John M. Inadomi

Microsatellite instability is an alternative pathway to cancer. Hereditary nonpolyposis colorectal cancer (Lynch syndrome) is representative of this pathway with common abnormalities in mismatch repair genes such as MLH1, MSH2, MSH6, or PMS2. Lynch syndrome patients are BRAF and CIMP negative. This is in contrast to a more recent pathway to cancer that arises from sessile serrated polyps that also display microsatellite instability, but are BRAF and CIMP positive.

The clinical importance of understanding the pathway through which cancer develops in an individual patient is that depending on the mechanism of tumorigenesis, different treatment strategies can prevent or treat cancer. For example, exciting novel therapies are being developed for microsatellite unstable cancers using immune checkpoint inhibitors. Aspirin can reduce CRC mortality, especially tumors that overexpress COX2 or harbor PIK3CA mutations, and have demonstrated benefit even postoperatively in patients receiving surgical resection of CRC.

I gave a talk focused on current guidelines for reducing mortality among individuals at average risk for developing CRC. The U.S. Preventive Services Task Force updated their recommendations this year and chose to focus on highlighting the importance of CRC screening between the ages of 50 and 75 years, tailored screening for those between the ages of 76 and 85 years, and stopping screening after age 85 years. However, the statement does not recommend specific tests and instead lists competing strategies of annual fecal immunochemical test (FIT) or highly sensitive fecal occult blood test (FOBT) with or without flexible sigmoidoscopy every 10 years, flexible sigmoidoscopy every 5 years, colonoscopy every 10 years, CT colonography every 5 years, and FIT-DNA every 1 or 3 years. The FIT-DNA adds a separate FIT to a stool exam for KRAS mutations, NDRG4 and BMP3 methylation, and beta-actin. There are no studies to determine whether CRC mortality is reduced, but one study demonstrated a higher sensitivity for CRC with the combined FIT-DNA, compared with FIT alone, but a lower specificity. The FDA also recently approved a blood-based CRC screening test that detects circulating methylated septin 9 gene DNA. Septin 9 is a gene that codes for GTP-binding protein and acts as a tumor suppressor that can be inactivated by methylation.

Irrespective of which strategy is pursued, colonoscopy is the final common pathway. Quality is important because there remains a disappointing rate of CRC after colonoscopy. Prior work has demonstrated significant differences in the adenoma detection rate (ADR) between endoscopists in the same practice. A recent Kaiser study found that for every 1% increase in the ADR there is a 3% decrease in the rate of cancer developing after colonoscopy.

Disruptive technology is emerging that may displace gastroenterologists from primary endoscopic screening. A self-propelled disposable colonoscope (Aer-O-Scope) has been developed that uses pneumatic pressure to advance a tethered camera through the colonic lumen guided by a joystick. Sedation is not required and the device does not need manual advancement, facilitating use by nongastroenterologists.

Uri Ladabaum, MD, of Stanford (Calif.) University presented the clinical impact of screening for hereditary and familial CRC. Lynch syndrome is characterized by a family history of cancer in at least three individuals spanning at least two generations including one with early cancer development. He reminded us that Lynch syndrome cancers are not limited to CRC but also include uterine, ovarian, gastric, small intestinal, urinary, biliary, pancreatic, and neurologic tumors. Microsatellite instability is likely present, mismatch repair gene abnormalities should be sought, and screening should include colonoscopy every 1-2 years. Aspirin chemoprophylaxis should be recommended, as should prophylactic hysterectomy and oophorectomy among affected women due to the uterine and ovarian cancer risk.

Polyposis syndromes constitute a separate group of hereditary cancers that includes familial adenomatous polyposis (FAP) arising from defects in the APC gene that may present as florid or attenuated FAP, and MYH-associated polyposis. If a patient presents with more than 10 adenomas, a polyposis syndrome should be considered. More rare syndromes include Cowden, juvenile polyposis, and Peutz-Jeghers.

 

 

Douglas Rex, MD, of Indiana University, Indianapolis, provided an array of highly clinically relevant tips to improve screening colonoscopy quality, which has been shown to reduce CRC mortality. Some of the basic concepts include using split-dose preparations and high-definition endoscopes, measuring and reporting adenoma detection rates, and using water immersion with carbon dioxide instead of air insufflation. Special attention was given to the diagnosis and removal of sessile lesions of the colon. Dr. Rex revealed many of his “tricks” to achieving high-quality colonoscopy, which include retroflexion to access polyps behind folds, using a stiff snare, and attaching a cap to the end of the colonoscope in order to facilitate visualization of polyps and assist in the mucosal resection of sessile lesions. Dr. Rex also presented data to support his recommendation to use “avulsion” with cold snare and forceps while limiting coagulative ablation for residual polyp tissue.

Finally, Rajeev Jain, MD, of Dallas presented the rapidly evolving area of reimbursement reform including the Medicare Access and CHIP Reauthorization Act (MACRA) that is driving payment away from fee-for-service and towards bundled payments, accountable care networks, and patient-centered medical homes. Key to this reform is the documentation and reporting of quality for procedural and cognitive patient encounters. There are limited performance measures specific to gastroenterology and hepatology, which currently include measures to both document appropriate CRC screening and reduce colonoscopy overuse, inflammatory bowel disease management, and hepatitis C management. However, there are many cost-cutting measures that can also be reported by gastroenterologists to fulfill these requirements. The Physician Quality Reporting System requires at least nine measures for at least 50% of Medicare patients in order to avoid penalties. It is not enough to track and document quality measures – results must also be reported through CMS-approved entities called qualified clinical data registries.

Dr. Jain described the movement toward payment bundles in which a single reimbursement is provided for services rendered by all providers and sites across a single episode of care. Screening colonoscopy was used as an example of how this could impact gastroenterology: a single payment would be provided for the preprocedure evaluation and education, the procedure itself (including endoscopy, anesthesia, pathology, facility), and postprocedure follow-up. Additional payments would not be provided for additional services such as repeating the colonoscopy because of a poor preparation or to treat postpolypectomy bleeding. Overall, health care reimbursement is moving to recognize value (quality/cost), reduce variation in care, and transfer more of the financial risk to health care providers and systems.

Dr. Inadomi, division of gastroenterology, department of medicine, University of Washington School of Medicine, department of health services, University of Washington School of Public Health, Seattle. He is on the clinical advisory committee for ChemImage and on the scientific advisory board for Epigenomics.

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Inflammatory bowel disease

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Inflammatory bowel disease

For the Spring Postgraduate Course session on inflammatory bowel disease (IBD), we were fortunate to secure four of the best educators on IBD in the American Gastroenterological Association.

William Sandborn, MD, of the University of California, San Diego, led the session with an overview of the immunomodulators and biologics that are employed for the treatment of Crohn’s disease and ulcerative colitis in 2016, including the thiopurines, methotrexate, calcineurin inhibitors, anti–tumor necrosis factor (TNF) agents, anti-integrins, and upcoming therapies such as ustekinumab (anti-interleukins 12 and 23) and tofacitinib (Janus kinase antagonist).

Dr. Edward V. Loftus Jr.
Dr. Edward V. Loftus Jr.

The evidence base for thiopurine monotherapy in IBD is weaker than we had once assumed, and the combination of infliximab and azathioprine remains the gold standard in efficacy with respect to steroid-free remission. Methotrexate remains a reasonable option as an immunomodulator, especially for patients who can’t tolerate thiopurines or who are risk averse. Cyclosporine has a niche indication for the treatment of acute severe colitis, and is at least equivalent to infliximab for that indication.

We have a total of four anti-TNF agents approved for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, including infliximab, adalimumab, certolizumab pegol (Crohn’s only), and golimumab (ulcerative colitis only). The infliximab biosimilar CT-P13 is approved for IBD in several countries. The anti-integrin, vedolizumab, is approved for both moderate to severe ulcerative colitis and Crohn’s disease. Ustekinumab was shown to be more effective than placebo in inducing clinical response and remission in moderate to severe Crohn’s disease patients who were either refractory/intolerant to or naive to anti-TNF therapy. Tofacitinib was recently shown in two trials to be more effective than placebo in inducing clinical remission and mucosal healing in patients with moderate to severe ulcerative colitis.

Maria Abreu, MD, from the University of Miami highlighted the fact that although our current therapies are far more effective than previous ones, they can be problematic, and dose adjustment is often needed. We should tailor our treatment plan based on our assessment of the patient’s risk for intestinal complications or surgery – patients with multiple risk factors such as young age at diagnosis, extensive involvement, deep ulcers, previous surgeries, or penetrating/stricturing behavior at baseline should be treated more aggressively, perhaps with a top-down approach. In general, biologics will be more effective when used in combination with immunomodulators. Monotherapy can be considered in patients with low inflammatory burden, few risk factors for more severe disease, or in those at high risk for complications from combination therapy.

At least one way in which concomitant immunomodulator therapy exerts its beneficial effect is by increasing trough levels of the biologic. One recent study of the relationship between adalimumab levels and endoscopic inflammation suggested that the median adalimumab trough level associated with mucosal healing was 13.5 mcg/mL. Patients with low drug levels and no or low levels of anti-drug antibodies should undergo dose escalation. Those with absent drug levels and high levels of antibodies should switch to a different agent. If the drug level is considered adequate and yet inflammation is still present, consideration should be given to switching to a biologic with a different mechanism of action. In some patients with low levels of antibodies who are on monotherapy, there may be a role for adding an immunomodulator in an attempt to suppress antibody formation. The importance of vedolizumab and ustekinumab as biologics with different mechanisms of action was also highlighted. An exciting class of biologics currently under development is the anti–IL-23 class, including drugs such as risankizumab and MEDI-2070.

David T. Rubin, MD, from the University of Chicago reviewed the various complications associated with IBD and its therapies. Disease-related complications include clinical flares, bowel obstruction, fistula/abscess formation, intestinal cancer, the need for surgery (sometimes more than one), and extraintestinal manifestations. More accurate diagnosis and earlier effective therapies may help to reduce the risk of these complications. Certain infections such as herpes zoster, pneumonia, and Clostridium difficile infection appear to occur more commonly in IBD patients. The TREAT registry showed that the use of corticosteroids is associated with an increased risk of serious infections and mortality, and the use of infliximab is associated with an increased risk of serious infection. C. difficile infection in particular can be problematic, and should be treated aggressively. Thiopurines appear to increase the risk of lymphoma and nonmelanoma skin cancer. Lymphoma risk quickly reverts to baseline after thiopurines are discontinued. Overall, no increased risk of cancer can be demonstrated among patients on anti-TNF therapy, and patients with a history of cancer do not have an increased risk of recurrent or new cancers on anti-TNF therapy. There may be an association between anti-TNF use and melanoma, although this bears further study.

 

 

Miguel Regueiro, MD, from the University of Pittsburgh wrapped up the session with a talk on managing postoperative IBD patients. Although the ileal pouch–anal anastomosis (IPAA) broadened access to proctocolectomy, it is associated with several disorders, including pelvic sepsis, pouchitis, Crohn’s disease of the ileoanal pouch, cuffitis, and irritable pouch syndrome. At least 50% of IPAA patients will develop at least one episode of pouchitis. Most patients will respond to ciprofloxacin or metronidazole, but a small percentage will develop chronic pouchitis. Ileocecal resection for the complications of Crohn’s disease generally results in immediate improvements in quality of life, but unfortunately, most patients will develop endoscopic and eventually clinical recurrence. At 6-12 months after surgery, a Rutgeerts score of i2 or higher (at least five aphthous lesions in the neoterminal ileum) is associated with a high risk of clinical recurrence, and this finding can be used as a trigger for escalation of therapy.

Infliximab was associated with a markedly decreased risk of endoscopic recurrence in a small investigator-initiated trial, and subsequent studies have strongly suggested that infliximab and adalimumab reduce the risk of recurrence. Although the primary endpoint of clinical recurrence was not met in the large multicenter PREVENT trial, infliximab was shown to significantly decrease endoscopic recurrence. The POCER study showed that a slightly less proactive approach of watchful waiting in lower-risk patients and making decisions about therapy at the 6-month colonoscopy was a reasonable one. The risk factors one must consider in stratifying postop patients include early age at surgery, short time between diagnosis and surgery, cigarette smoking, penetrating disease behavior, and a history of previous resections.

Dr. Loftus is professor of medicine in the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn. He has consulted for and has received research support from Janssen, UCB, Takeda, and AbbVie.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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For the Spring Postgraduate Course session on inflammatory bowel disease (IBD), we were fortunate to secure four of the best educators on IBD in the American Gastroenterological Association.

William Sandborn, MD, of the University of California, San Diego, led the session with an overview of the immunomodulators and biologics that are employed for the treatment of Crohn’s disease and ulcerative colitis in 2016, including the thiopurines, methotrexate, calcineurin inhibitors, anti–tumor necrosis factor (TNF) agents, anti-integrins, and upcoming therapies such as ustekinumab (anti-interleukins 12 and 23) and tofacitinib (Janus kinase antagonist).

Dr. Edward V. Loftus Jr.
Dr. Edward V. Loftus Jr.

The evidence base for thiopurine monotherapy in IBD is weaker than we had once assumed, and the combination of infliximab and azathioprine remains the gold standard in efficacy with respect to steroid-free remission. Methotrexate remains a reasonable option as an immunomodulator, especially for patients who can’t tolerate thiopurines or who are risk averse. Cyclosporine has a niche indication for the treatment of acute severe colitis, and is at least equivalent to infliximab for that indication.

We have a total of four anti-TNF agents approved for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, including infliximab, adalimumab, certolizumab pegol (Crohn’s only), and golimumab (ulcerative colitis only). The infliximab biosimilar CT-P13 is approved for IBD in several countries. The anti-integrin, vedolizumab, is approved for both moderate to severe ulcerative colitis and Crohn’s disease. Ustekinumab was shown to be more effective than placebo in inducing clinical response and remission in moderate to severe Crohn’s disease patients who were either refractory/intolerant to or naive to anti-TNF therapy. Tofacitinib was recently shown in two trials to be more effective than placebo in inducing clinical remission and mucosal healing in patients with moderate to severe ulcerative colitis.

Maria Abreu, MD, from the University of Miami highlighted the fact that although our current therapies are far more effective than previous ones, they can be problematic, and dose adjustment is often needed. We should tailor our treatment plan based on our assessment of the patient’s risk for intestinal complications or surgery – patients with multiple risk factors such as young age at diagnosis, extensive involvement, deep ulcers, previous surgeries, or penetrating/stricturing behavior at baseline should be treated more aggressively, perhaps with a top-down approach. In general, biologics will be more effective when used in combination with immunomodulators. Monotherapy can be considered in patients with low inflammatory burden, few risk factors for more severe disease, or in those at high risk for complications from combination therapy.

At least one way in which concomitant immunomodulator therapy exerts its beneficial effect is by increasing trough levels of the biologic. One recent study of the relationship between adalimumab levels and endoscopic inflammation suggested that the median adalimumab trough level associated with mucosal healing was 13.5 mcg/mL. Patients with low drug levels and no or low levels of anti-drug antibodies should undergo dose escalation. Those with absent drug levels and high levels of antibodies should switch to a different agent. If the drug level is considered adequate and yet inflammation is still present, consideration should be given to switching to a biologic with a different mechanism of action. In some patients with low levels of antibodies who are on monotherapy, there may be a role for adding an immunomodulator in an attempt to suppress antibody formation. The importance of vedolizumab and ustekinumab as biologics with different mechanisms of action was also highlighted. An exciting class of biologics currently under development is the anti–IL-23 class, including drugs such as risankizumab and MEDI-2070.

David T. Rubin, MD, from the University of Chicago reviewed the various complications associated with IBD and its therapies. Disease-related complications include clinical flares, bowel obstruction, fistula/abscess formation, intestinal cancer, the need for surgery (sometimes more than one), and extraintestinal manifestations. More accurate diagnosis and earlier effective therapies may help to reduce the risk of these complications. Certain infections such as herpes zoster, pneumonia, and Clostridium difficile infection appear to occur more commonly in IBD patients. The TREAT registry showed that the use of corticosteroids is associated with an increased risk of serious infections and mortality, and the use of infliximab is associated with an increased risk of serious infection. C. difficile infection in particular can be problematic, and should be treated aggressively. Thiopurines appear to increase the risk of lymphoma and nonmelanoma skin cancer. Lymphoma risk quickly reverts to baseline after thiopurines are discontinued. Overall, no increased risk of cancer can be demonstrated among patients on anti-TNF therapy, and patients with a history of cancer do not have an increased risk of recurrent or new cancers on anti-TNF therapy. There may be an association between anti-TNF use and melanoma, although this bears further study.

 

 

Miguel Regueiro, MD, from the University of Pittsburgh wrapped up the session with a talk on managing postoperative IBD patients. Although the ileal pouch–anal anastomosis (IPAA) broadened access to proctocolectomy, it is associated with several disorders, including pelvic sepsis, pouchitis, Crohn’s disease of the ileoanal pouch, cuffitis, and irritable pouch syndrome. At least 50% of IPAA patients will develop at least one episode of pouchitis. Most patients will respond to ciprofloxacin or metronidazole, but a small percentage will develop chronic pouchitis. Ileocecal resection for the complications of Crohn’s disease generally results in immediate improvements in quality of life, but unfortunately, most patients will develop endoscopic and eventually clinical recurrence. At 6-12 months after surgery, a Rutgeerts score of i2 or higher (at least five aphthous lesions in the neoterminal ileum) is associated with a high risk of clinical recurrence, and this finding can be used as a trigger for escalation of therapy.

Infliximab was associated with a markedly decreased risk of endoscopic recurrence in a small investigator-initiated trial, and subsequent studies have strongly suggested that infliximab and adalimumab reduce the risk of recurrence. Although the primary endpoint of clinical recurrence was not met in the large multicenter PREVENT trial, infliximab was shown to significantly decrease endoscopic recurrence. The POCER study showed that a slightly less proactive approach of watchful waiting in lower-risk patients and making decisions about therapy at the 6-month colonoscopy was a reasonable one. The risk factors one must consider in stratifying postop patients include early age at surgery, short time between diagnosis and surgery, cigarette smoking, penetrating disease behavior, and a history of previous resections.

Dr. Loftus is professor of medicine in the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn. He has consulted for and has received research support from Janssen, UCB, Takeda, and AbbVie.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

For the Spring Postgraduate Course session on inflammatory bowel disease (IBD), we were fortunate to secure four of the best educators on IBD in the American Gastroenterological Association.

William Sandborn, MD, of the University of California, San Diego, led the session with an overview of the immunomodulators and biologics that are employed for the treatment of Crohn’s disease and ulcerative colitis in 2016, including the thiopurines, methotrexate, calcineurin inhibitors, anti–tumor necrosis factor (TNF) agents, anti-integrins, and upcoming therapies such as ustekinumab (anti-interleukins 12 and 23) and tofacitinib (Janus kinase antagonist).

Dr. Edward V. Loftus Jr.
Dr. Edward V. Loftus Jr.

The evidence base for thiopurine monotherapy in IBD is weaker than we had once assumed, and the combination of infliximab and azathioprine remains the gold standard in efficacy with respect to steroid-free remission. Methotrexate remains a reasonable option as an immunomodulator, especially for patients who can’t tolerate thiopurines or who are risk averse. Cyclosporine has a niche indication for the treatment of acute severe colitis, and is at least equivalent to infliximab for that indication.

We have a total of four anti-TNF agents approved for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, including infliximab, adalimumab, certolizumab pegol (Crohn’s only), and golimumab (ulcerative colitis only). The infliximab biosimilar CT-P13 is approved for IBD in several countries. The anti-integrin, vedolizumab, is approved for both moderate to severe ulcerative colitis and Crohn’s disease. Ustekinumab was shown to be more effective than placebo in inducing clinical response and remission in moderate to severe Crohn’s disease patients who were either refractory/intolerant to or naive to anti-TNF therapy. Tofacitinib was recently shown in two trials to be more effective than placebo in inducing clinical remission and mucosal healing in patients with moderate to severe ulcerative colitis.

Maria Abreu, MD, from the University of Miami highlighted the fact that although our current therapies are far more effective than previous ones, they can be problematic, and dose adjustment is often needed. We should tailor our treatment plan based on our assessment of the patient’s risk for intestinal complications or surgery – patients with multiple risk factors such as young age at diagnosis, extensive involvement, deep ulcers, previous surgeries, or penetrating/stricturing behavior at baseline should be treated more aggressively, perhaps with a top-down approach. In general, biologics will be more effective when used in combination with immunomodulators. Monotherapy can be considered in patients with low inflammatory burden, few risk factors for more severe disease, or in those at high risk for complications from combination therapy.

At least one way in which concomitant immunomodulator therapy exerts its beneficial effect is by increasing trough levels of the biologic. One recent study of the relationship between adalimumab levels and endoscopic inflammation suggested that the median adalimumab trough level associated with mucosal healing was 13.5 mcg/mL. Patients with low drug levels and no or low levels of anti-drug antibodies should undergo dose escalation. Those with absent drug levels and high levels of antibodies should switch to a different agent. If the drug level is considered adequate and yet inflammation is still present, consideration should be given to switching to a biologic with a different mechanism of action. In some patients with low levels of antibodies who are on monotherapy, there may be a role for adding an immunomodulator in an attempt to suppress antibody formation. The importance of vedolizumab and ustekinumab as biologics with different mechanisms of action was also highlighted. An exciting class of biologics currently under development is the anti–IL-23 class, including drugs such as risankizumab and MEDI-2070.

David T. Rubin, MD, from the University of Chicago reviewed the various complications associated with IBD and its therapies. Disease-related complications include clinical flares, bowel obstruction, fistula/abscess formation, intestinal cancer, the need for surgery (sometimes more than one), and extraintestinal manifestations. More accurate diagnosis and earlier effective therapies may help to reduce the risk of these complications. Certain infections such as herpes zoster, pneumonia, and Clostridium difficile infection appear to occur more commonly in IBD patients. The TREAT registry showed that the use of corticosteroids is associated with an increased risk of serious infections and mortality, and the use of infliximab is associated with an increased risk of serious infection. C. difficile infection in particular can be problematic, and should be treated aggressively. Thiopurines appear to increase the risk of lymphoma and nonmelanoma skin cancer. Lymphoma risk quickly reverts to baseline after thiopurines are discontinued. Overall, no increased risk of cancer can be demonstrated among patients on anti-TNF therapy, and patients with a history of cancer do not have an increased risk of recurrent or new cancers on anti-TNF therapy. There may be an association between anti-TNF use and melanoma, although this bears further study.

 

 

Miguel Regueiro, MD, from the University of Pittsburgh wrapped up the session with a talk on managing postoperative IBD patients. Although the ileal pouch–anal anastomosis (IPAA) broadened access to proctocolectomy, it is associated with several disorders, including pelvic sepsis, pouchitis, Crohn’s disease of the ileoanal pouch, cuffitis, and irritable pouch syndrome. At least 50% of IPAA patients will develop at least one episode of pouchitis. Most patients will respond to ciprofloxacin or metronidazole, but a small percentage will develop chronic pouchitis. Ileocecal resection for the complications of Crohn’s disease generally results in immediate improvements in quality of life, but unfortunately, most patients will develop endoscopic and eventually clinical recurrence. At 6-12 months after surgery, a Rutgeerts score of i2 or higher (at least five aphthous lesions in the neoterminal ileum) is associated with a high risk of clinical recurrence, and this finding can be used as a trigger for escalation of therapy.

Infliximab was associated with a markedly decreased risk of endoscopic recurrence in a small investigator-initiated trial, and subsequent studies have strongly suggested that infliximab and adalimumab reduce the risk of recurrence. Although the primary endpoint of clinical recurrence was not met in the large multicenter PREVENT trial, infliximab was shown to significantly decrease endoscopic recurrence. The POCER study showed that a slightly less proactive approach of watchful waiting in lower-risk patients and making decisions about therapy at the 6-month colonoscopy was a reasonable one. The risk factors one must consider in stratifying postop patients include early age at surgery, short time between diagnosis and surgery, cigarette smoking, penetrating disease behavior, and a history of previous resections.

Dr. Loftus is professor of medicine in the division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn. He has consulted for and has received research support from Janssen, UCB, Takeda, and AbbVie.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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Strange bedfellows: FMT and esophageal disease

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Tue, 12/13/2016 - 10:27
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Strange bedfellows: FMT and esophageal disease

Fecal microbiota transplant (FMT) and esophageal disease were strange bedfellows in a series of informative lectures by world experts in their respective fields.

FMT breaks the cycle of resistant Clostridium difficile infection, where resistant bacteria overwhelm innate gut flora following antibiotic use. FMT introduces competition for nutrients and microbiota-derived bacteriocins targeting resistant bacteria, restores secondary bile salt metabolism, and stimulates mucosal immunity against resistant bacteria. The potential for FMT to benefit diseases other than recurrent C. difficile infection continues to be explored.

Dr. C. Prakash Gyawali
Dr. C. Prakash Gyawali

Eosinophilic esophagitis (EoE) is characterized clinically by dysphagia and food impaction, and pathologically by eosinophil-dominant inflammation (at least 15 eosinophils/high-power field on biopsy). Esophageal subepithelial fibrosis contributes to a narrow caliber, poorly distensible esophagus. Alternative causes of esophageal eosinophilia, particularly that induced by reflux, need to be excluded. Proton pump inhibitor (PPI) response does not distinguish EoE from reflux disease, but management starts with these drugs. Swallowed topical steroids, and the six-food elimination diet are alternative effective therapies. Biologic agents are being evaluated as future therapeutic options.

High-resolution manometry (HRM) has improved acquisition and display of esophageal pressure data, simplifying interpretation using three software tools, integrated relaxation pressure, distal contractile integral, and distal latency. Stationary impedance with HRM (high-resolution impedance manometry, HRIM) provides further gains in esophageal bolus transit assessment. Automated impedance manometry analysis, esophageal impedance integral ratio, bolus flow time, and functional lumen imaging probe–derived metrics add to esophageal physiologic assessments and esophageal function testing.

Rare disorders such as esophageal lichen planus can manifest with dysphagia and esophageal inflammation and strictures; these disorders are managed with immunosuppressive agents and cautious endoscopic dilation. Rumination (regurgitation of recently ingested food) and belching (with aerophagy) mimic reflux disease. These are distinguished using HRIM and pH-impedance monitoring, and treated with diaphragmatic breathing. Early postfundoplication dysphagia is common and responds to dilation; peptic strictures or slipped fundoplication needing wrap revision can cause late dysphagia. Scleroderma esophagus can be difficult to differentiate from advanced achalasia. Pneumatic dilation can benefit postmyotomy dysphagia.

Low-grade dysplasia within Barrett’s esophagus has a variable natural history, primarily from overdiagnosis and interobserver variation; many patients are down-staged upon review. Progression to high-grade dysplasia or intramucosal cancer (0.5%-1.7% per annum) is higher with confirmed low-grade dysplasia. Consequently, guidelines recommend review by expert pathologists and surveillance after 6-12 months. Evidence for radiofrequency ablation in carefully selected patients continues to grow. Radiofrequency ablation eliminates dysplasia and reduces the risk of progression to high-grade dysplasia. Better markers for diagnosis and prognosis continue to be studied.

Dr. Gyawali is professor of medicine, division of gastroenterology, Washington University in St. Louis. He has consulted for and received speaking fees or research funding from Medtronic, Torax, Ironwood, and Allergan.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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Fecal microbiota transplant (FMT) and esophageal disease were strange bedfellows in a series of informative lectures by world experts in their respective fields.

FMT breaks the cycle of resistant Clostridium difficile infection, where resistant bacteria overwhelm innate gut flora following antibiotic use. FMT introduces competition for nutrients and microbiota-derived bacteriocins targeting resistant bacteria, restores secondary bile salt metabolism, and stimulates mucosal immunity against resistant bacteria. The potential for FMT to benefit diseases other than recurrent C. difficile infection continues to be explored.

Dr. C. Prakash Gyawali
Dr. C. Prakash Gyawali

Eosinophilic esophagitis (EoE) is characterized clinically by dysphagia and food impaction, and pathologically by eosinophil-dominant inflammation (at least 15 eosinophils/high-power field on biopsy). Esophageal subepithelial fibrosis contributes to a narrow caliber, poorly distensible esophagus. Alternative causes of esophageal eosinophilia, particularly that induced by reflux, need to be excluded. Proton pump inhibitor (PPI) response does not distinguish EoE from reflux disease, but management starts with these drugs. Swallowed topical steroids, and the six-food elimination diet are alternative effective therapies. Biologic agents are being evaluated as future therapeutic options.

High-resolution manometry (HRM) has improved acquisition and display of esophageal pressure data, simplifying interpretation using three software tools, integrated relaxation pressure, distal contractile integral, and distal latency. Stationary impedance with HRM (high-resolution impedance manometry, HRIM) provides further gains in esophageal bolus transit assessment. Automated impedance manometry analysis, esophageal impedance integral ratio, bolus flow time, and functional lumen imaging probe–derived metrics add to esophageal physiologic assessments and esophageal function testing.

Rare disorders such as esophageal lichen planus can manifest with dysphagia and esophageal inflammation and strictures; these disorders are managed with immunosuppressive agents and cautious endoscopic dilation. Rumination (regurgitation of recently ingested food) and belching (with aerophagy) mimic reflux disease. These are distinguished using HRIM and pH-impedance monitoring, and treated with diaphragmatic breathing. Early postfundoplication dysphagia is common and responds to dilation; peptic strictures or slipped fundoplication needing wrap revision can cause late dysphagia. Scleroderma esophagus can be difficult to differentiate from advanced achalasia. Pneumatic dilation can benefit postmyotomy dysphagia.

Low-grade dysplasia within Barrett’s esophagus has a variable natural history, primarily from overdiagnosis and interobserver variation; many patients are down-staged upon review. Progression to high-grade dysplasia or intramucosal cancer (0.5%-1.7% per annum) is higher with confirmed low-grade dysplasia. Consequently, guidelines recommend review by expert pathologists and surveillance after 6-12 months. Evidence for radiofrequency ablation in carefully selected patients continues to grow. Radiofrequency ablation eliminates dysplasia and reduces the risk of progression to high-grade dysplasia. Better markers for diagnosis and prognosis continue to be studied.

Dr. Gyawali is professor of medicine, division of gastroenterology, Washington University in St. Louis. He has consulted for and received speaking fees or research funding from Medtronic, Torax, Ironwood, and Allergan.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

Fecal microbiota transplant (FMT) and esophageal disease were strange bedfellows in a series of informative lectures by world experts in their respective fields.

FMT breaks the cycle of resistant Clostridium difficile infection, where resistant bacteria overwhelm innate gut flora following antibiotic use. FMT introduces competition for nutrients and microbiota-derived bacteriocins targeting resistant bacteria, restores secondary bile salt metabolism, and stimulates mucosal immunity against resistant bacteria. The potential for FMT to benefit diseases other than recurrent C. difficile infection continues to be explored.

Dr. C. Prakash Gyawali
Dr. C. Prakash Gyawali

Eosinophilic esophagitis (EoE) is characterized clinically by dysphagia and food impaction, and pathologically by eosinophil-dominant inflammation (at least 15 eosinophils/high-power field on biopsy). Esophageal subepithelial fibrosis contributes to a narrow caliber, poorly distensible esophagus. Alternative causes of esophageal eosinophilia, particularly that induced by reflux, need to be excluded. Proton pump inhibitor (PPI) response does not distinguish EoE from reflux disease, but management starts with these drugs. Swallowed topical steroids, and the six-food elimination diet are alternative effective therapies. Biologic agents are being evaluated as future therapeutic options.

High-resolution manometry (HRM) has improved acquisition and display of esophageal pressure data, simplifying interpretation using three software tools, integrated relaxation pressure, distal contractile integral, and distal latency. Stationary impedance with HRM (high-resolution impedance manometry, HRIM) provides further gains in esophageal bolus transit assessment. Automated impedance manometry analysis, esophageal impedance integral ratio, bolus flow time, and functional lumen imaging probe–derived metrics add to esophageal physiologic assessments and esophageal function testing.

Rare disorders such as esophageal lichen planus can manifest with dysphagia and esophageal inflammation and strictures; these disorders are managed with immunosuppressive agents and cautious endoscopic dilation. Rumination (regurgitation of recently ingested food) and belching (with aerophagy) mimic reflux disease. These are distinguished using HRIM and pH-impedance monitoring, and treated with diaphragmatic breathing. Early postfundoplication dysphagia is common and responds to dilation; peptic strictures or slipped fundoplication needing wrap revision can cause late dysphagia. Scleroderma esophagus can be difficult to differentiate from advanced achalasia. Pneumatic dilation can benefit postmyotomy dysphagia.

Low-grade dysplasia within Barrett’s esophagus has a variable natural history, primarily from overdiagnosis and interobserver variation; many patients are down-staged upon review. Progression to high-grade dysplasia or intramucosal cancer (0.5%-1.7% per annum) is higher with confirmed low-grade dysplasia. Consequently, guidelines recommend review by expert pathologists and surveillance after 6-12 months. Evidence for radiofrequency ablation in carefully selected patients continues to grow. Radiofrequency ablation eliminates dysplasia and reduces the risk of progression to high-grade dysplasia. Better markers for diagnosis and prognosis continue to be studied.

Dr. Gyawali is professor of medicine, division of gastroenterology, Washington University in St. Louis. He has consulted for and received speaking fees or research funding from Medtronic, Torax, Ironwood, and Allergan.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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Eliminating the anxiety of managing functional GI disorders

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Kicking off the 2016 AGA Spring Postgraduate Course, this symposium encouraged attendees to embrace multidisciplinary approaches to managing patients with common gastrointestinal symptoms of nonstructural origin. My talk on “Managing the Big Four – Dyspepsia, Constipation, Diarrhea, and Abdominal Pain” reviewed the pathophysiology and management of these conditions. Thereafter, Sheila Crowe, MD, AGAF, Laurie Keefer, PhD, and Michael Camilleri, MD, AGAF, respectively, reviewed dietary approaches, psychological, and behavioral therapies, and overlooked, overused, and emerging pharmacotherapy for managing these conditions.

Dr. Adil E. Bharucha
Dr. Adil E. Bharucha

The clinical evaluation enables a precise symptom-based diagnosis of these conditions (e.g., dyspepsia, diarrhea-predominant irritable bowel syndrome [IBS], chronic constipation, defecatory disorders, and chronic abdominal pain). Dr. Keefer emphasized the importance of setting a pro-solution agenda early in the interview as well as listening, understanding, and believing symptoms. Empathy is essential. At the same time, patients need to assume personal responsibility and contribute to their own wellness. Expectations and a treatment plan should be negotiated. Bowel symptom questionnaires and, if necessary, bowel diaries ensure that symptoms are addressed comprehensively and save time. A meticulous digital rectal exam is essential since defecatory disorders are associated with not only lower but also upper GI symptoms. Only selected diagnostic tests, guided by the clinical features, should be performed.

Our understanding of the pathophysiology is evolving. Functional dyspepsia is implicated to impaired gastric accommodation, delayed gastric emptying, and increased gastric as well as duodenal sensitivity. Peripheral irritation (e.g., due to persistent low-grade inflammation after resolution of acute gastroenteritis or bile acids) and central dysfunctions (e.g., resulting from anxiety or depression) can alter GI transit and sensitivity resulting in IBS. Slow colon transit and impaired defecation (i.e., defecatory disorders) can cause chronic constipation.

Initially, therapy should utilize inexpensive, over-the-counter agents (loperamide for diarrhea). Dr. Camilleri also highlighted the utility of bile acid binding agents (e.g., cholestyramine and colesevelam) and when necessary, alosteron for diarrhea and cautioned attendees to use rifaximin as recommended by the Food and Drug Administration (i.e., up to three courses of 2 weeks) and not for long-term therapy. Several newer agents for these disorders are being developed. Dr. Crowe reminded the audience that foods often induce symptoms. In a recent study, a “common-sense” IBS diet was as effective as was a low-FODMAP diet for IBS. Eliminating gluten or wheat starch may benefit some patients with IBS without celiac disease but more evidence is required. Dr. Keefer highlighted the utility of diaphragmatic breathing for rumination, pelvic floor biofeedback therapy for defecatory disorders, and psychological therapies, especially cognitive behavioral therapy, for patients with a variety of GI symptoms.

Dr. Bharucha is with the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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Kicking off the 2016 AGA Spring Postgraduate Course, this symposium encouraged attendees to embrace multidisciplinary approaches to managing patients with common gastrointestinal symptoms of nonstructural origin. My talk on “Managing the Big Four – Dyspepsia, Constipation, Diarrhea, and Abdominal Pain” reviewed the pathophysiology and management of these conditions. Thereafter, Sheila Crowe, MD, AGAF, Laurie Keefer, PhD, and Michael Camilleri, MD, AGAF, respectively, reviewed dietary approaches, psychological, and behavioral therapies, and overlooked, overused, and emerging pharmacotherapy for managing these conditions.

Dr. Adil E. Bharucha
Dr. Adil E. Bharucha

The clinical evaluation enables a precise symptom-based diagnosis of these conditions (e.g., dyspepsia, diarrhea-predominant irritable bowel syndrome [IBS], chronic constipation, defecatory disorders, and chronic abdominal pain). Dr. Keefer emphasized the importance of setting a pro-solution agenda early in the interview as well as listening, understanding, and believing symptoms. Empathy is essential. At the same time, patients need to assume personal responsibility and contribute to their own wellness. Expectations and a treatment plan should be negotiated. Bowel symptom questionnaires and, if necessary, bowel diaries ensure that symptoms are addressed comprehensively and save time. A meticulous digital rectal exam is essential since defecatory disorders are associated with not only lower but also upper GI symptoms. Only selected diagnostic tests, guided by the clinical features, should be performed.

Our understanding of the pathophysiology is evolving. Functional dyspepsia is implicated to impaired gastric accommodation, delayed gastric emptying, and increased gastric as well as duodenal sensitivity. Peripheral irritation (e.g., due to persistent low-grade inflammation after resolution of acute gastroenteritis or bile acids) and central dysfunctions (e.g., resulting from anxiety or depression) can alter GI transit and sensitivity resulting in IBS. Slow colon transit and impaired defecation (i.e., defecatory disorders) can cause chronic constipation.

Initially, therapy should utilize inexpensive, over-the-counter agents (loperamide for diarrhea). Dr. Camilleri also highlighted the utility of bile acid binding agents (e.g., cholestyramine and colesevelam) and when necessary, alosteron for diarrhea and cautioned attendees to use rifaximin as recommended by the Food and Drug Administration (i.e., up to three courses of 2 weeks) and not for long-term therapy. Several newer agents for these disorders are being developed. Dr. Crowe reminded the audience that foods often induce symptoms. In a recent study, a “common-sense” IBS diet was as effective as was a low-FODMAP diet for IBS. Eliminating gluten or wheat starch may benefit some patients with IBS without celiac disease but more evidence is required. Dr. Keefer highlighted the utility of diaphragmatic breathing for rumination, pelvic floor biofeedback therapy for defecatory disorders, and psychological therapies, especially cognitive behavioral therapy, for patients with a variety of GI symptoms.

Dr. Bharucha is with the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

Kicking off the 2016 AGA Spring Postgraduate Course, this symposium encouraged attendees to embrace multidisciplinary approaches to managing patients with common gastrointestinal symptoms of nonstructural origin. My talk on “Managing the Big Four – Dyspepsia, Constipation, Diarrhea, and Abdominal Pain” reviewed the pathophysiology and management of these conditions. Thereafter, Sheila Crowe, MD, AGAF, Laurie Keefer, PhD, and Michael Camilleri, MD, AGAF, respectively, reviewed dietary approaches, psychological, and behavioral therapies, and overlooked, overused, and emerging pharmacotherapy for managing these conditions.

Dr. Adil E. Bharucha
Dr. Adil E. Bharucha

The clinical evaluation enables a precise symptom-based diagnosis of these conditions (e.g., dyspepsia, diarrhea-predominant irritable bowel syndrome [IBS], chronic constipation, defecatory disorders, and chronic abdominal pain). Dr. Keefer emphasized the importance of setting a pro-solution agenda early in the interview as well as listening, understanding, and believing symptoms. Empathy is essential. At the same time, patients need to assume personal responsibility and contribute to their own wellness. Expectations and a treatment plan should be negotiated. Bowel symptom questionnaires and, if necessary, bowel diaries ensure that symptoms are addressed comprehensively and save time. A meticulous digital rectal exam is essential since defecatory disorders are associated with not only lower but also upper GI symptoms. Only selected diagnostic tests, guided by the clinical features, should be performed.

Our understanding of the pathophysiology is evolving. Functional dyspepsia is implicated to impaired gastric accommodation, delayed gastric emptying, and increased gastric as well as duodenal sensitivity. Peripheral irritation (e.g., due to persistent low-grade inflammation after resolution of acute gastroenteritis or bile acids) and central dysfunctions (e.g., resulting from anxiety or depression) can alter GI transit and sensitivity resulting in IBS. Slow colon transit and impaired defecation (i.e., defecatory disorders) can cause chronic constipation.

Initially, therapy should utilize inexpensive, over-the-counter agents (loperamide for diarrhea). Dr. Camilleri also highlighted the utility of bile acid binding agents (e.g., cholestyramine and colesevelam) and when necessary, alosteron for diarrhea and cautioned attendees to use rifaximin as recommended by the Food and Drug Administration (i.e., up to three courses of 2 weeks) and not for long-term therapy. Several newer agents for these disorders are being developed. Dr. Crowe reminded the audience that foods often induce symptoms. In a recent study, a “common-sense” IBS diet was as effective as was a low-FODMAP diet for IBS. Eliminating gluten or wheat starch may benefit some patients with IBS without celiac disease but more evidence is required. Dr. Keefer highlighted the utility of diaphragmatic breathing for rumination, pelvic floor biofeedback therapy for defecatory disorders, and psychological therapies, especially cognitive behavioral therapy, for patients with a variety of GI symptoms.

Dr. Bharucha is with the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.

This is a summary provided by the moderator of one of the spring postgraduate course sessions held at DDW 2016.

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AGA Presidential Address

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As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations — decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice — to be paid via the Merit-based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High value, cost conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Dr. Martin Brotman for innumerable contributions over almost 3 decades as a leader of the AGA, and Dr. Richard Boland as the Julius Friedenwald Medal awardee.

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As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations — decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice — to be paid via the Merit-based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High value, cost conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Dr. Martin Brotman for innumerable contributions over almost 3 decades as a leader of the AGA, and Dr. Richard Boland as the Julius Friedenwald Medal awardee.

As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations — decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice — to be paid via the Merit-based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High value, cost conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Dr. Martin Brotman for innumerable contributions over almost 3 decades as a leader of the AGA, and Dr. Richard Boland as the Julius Friedenwald Medal awardee.

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As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

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As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

Dr. Michael Camilleri
AGA Institute
Dr. Michael Camilleri

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

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Endobariatrics: Coming to a clinic near you

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SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

 

Dr. Steven Edmundowicz
Dr. Steven Edmundowicz

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

 

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

 

 

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

aotto@frontlinemedcom.com

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SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

 

Dr. Steven Edmundowicz
Dr. Steven Edmundowicz

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

 

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

 

 

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

aotto@frontlinemedcom.com

SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.

The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.

 

Dr. Steven Edmundowicz
Dr. Steven Edmundowicz

Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.

“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.

Dr. Edmundowicz reviewed the latest developments presented at DDW.

 

Self-assembling magnets for dual-path enteral anastomoses

The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.

In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.

“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.

Duodenal mucosal resurfacing

The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.

Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.

There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.

Gastric balloons

Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.

The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.

“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.

Endoscopic sleeve gastroplasty

Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.

 

 

Aspiration therapy

With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.

One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.

“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.

The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.

aotto@frontlinemedcom.com

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As Preventive, H2RA Poses Risks for Patients on Clopidogrel After Bleeding Ulcer

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As Preventive, H2RA Poses Risks for Patients on Clopidogrel After Bleeding Ulcer

SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

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SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

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As preventive, H2RA poses risks for patients on clopidogrel after bleeding ulcer

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As preventive, H2RA poses risks for patients on clopidogrel after bleeding ulcer

SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

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SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

SAN DIEGO – New research suggests histamine-2 receptor antagonists aren’t a viable alternative to proton pump inhibitors to prevent recurrence of bleeding peptic ulcers in clopidogrel users.

U.S. and European agencies have warned of interactions between proton pump inhibitors (PPIs) and clopidogrel. But a study presented at the annual Digestive Disease Week finds significant upper GI events were much more common in patients who took famotidine (Protonix), a histamine-2 receptor antagonist (H2RA), compared with those who took pantoprazole (Pepcid), a PPI, as a preventive treatment.

Dr. Ping-I Hsu

“The findings will change the practice of some physicians who prescribe H2RA to prevent UGI [upper GI] events in clopidogrel users,” said study lead author Dr. Ping-I Hsu, chief of gastroenterology at Kaohsiung Veterans General Hospital and professor of medicine at National Yang-Ming University, both in Taiwan.

Currently, Dr. Hsu said, “physicians often use PPIs to prevent ulcer complications in clopidogrel users because it is the only drug proven useful in the prevention of peptic ulcers and ulcer complications in clopidogrel users.”

But “both the U.S. Food & Drug Administration and the European Medicines Agency have posted safety warnings and discourage the use of PPIs with clopidogrel unless absolutely necessary,” he said.

Enter the prospect of H2RA medications as an alternative. The new study, Dr. Hsu said, is the first to explore the GI protection effect and safety of H2RAs in patients on clopidogrel monotherapy.

The randomized prospective study followed 120 patients with a history of peptic ulcer bleeding (but not at initial endoscopy) and atherosclerosis. All long-term users of ADP receptor antagonists, they were assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Patients were examined via endoscopy when they experienced events like severe epigastric discomfort.

The famotidine group had more significant upper GI events (13.3%) than the pantoprazole group (1.7%). Diarrhea was equal in both groups (1.7%). Pneumonia was comparable (0% and 1.7% for pantoprazole and famotidine, respectively), as was fracture (1.7% and 0%).

Wider differences were found in acute myocardial infarction (1.5% and 4.5%), and cerebral vascular accident (0% and 3.4%) for pantoprazole and famotidine, respectively.

According to Dr. Hsu, three earlier studies linked concurrent use of PPIs and clopidogrel to significant increases in cardiovascular events. But this study linked a higher cardiac risk to the H2RA medication.

The researchers found no differences between the drugs in sequential changes of serum magnesium levels and bone mineral densities.

Dr. Hsu made this recommendation to physicians: “Please don’t use H2RAs to prevent peptic ulcer or ulcer complications in clopidogrel users. It is ineffective to prevent UGI [upper GI] events in clopidogrel users who have a history of ulcer bleeding. PPIs can effectively prevent UGI events in clopidogrel users with a history of ulcer bleeding.”

In addition, he said, the risk of thrombotic events is lower on a PPI.

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As preventive, H2RA poses risks for patients on clopidogrel after bleeding ulcer
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Key clinical point: Compared with PPIs, H2RAs pose more risks – on both GI and cardiovascular fronts – as a preventive in patients with atherosclerosis and a history of peptic ulcer bleeding.

Major finding: After 48 weeks, 1.7% of patients in the pantoprazole (PPI) group (n = 60) suffered significant upper GI events; 13.3% of patients in the famotidine (H2RA) group (n = 60) did (P = 0.017). Cardiovascular events were also more common in the H2RA group.

Data source: Randomized prospective study of 120 patients with history of peptic ulcer bleeding (but not at initial endoscopy) assigned to pantoprazole (40 mg daily) or famotidine (40 mg daily) for 48 weeks.

Disclosures: The study is hospital funded. The authors report no disclosures.