American Gastroenterological Association Institute Research Articles

AGA Institute Quality Measure Development for Intragastric Balloons in the Management of Obesity

This document presents the official recommendations of the American Gastroenterological Association (AGA) regarding quality measures related to intragastric balloons (IGBs) in the management of obesity. The current report outlines the process by which the AGA Quality Committee (QC) evaluates guidance statements published by the AGA’s Clinical Guidelines Committee to inform measure development. The following recommendations were developed by the QC in consultation with the Clinical Guidelines Committee.

AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori

AGA Institute Quality Measure Development for the Management of Gastric Intestinal Metaplasia With Helicobacter pylori

AGA Clinical Practice Update on Surveillance After Pathologically Curative Endoscopic Submucosal Dissection of Early Gastrointestinal Neoplasia in the United States: Commentary

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update was to review the available evidence and provide expert advice regarding surveillance using endoscopy and other relevant modalities after removal of dysplastic lesions and early gastrointestinal cancers with endoscopic submucosal dissection deemed to be pathologically curative. This Clinical Practice Update was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors, who are advanced endoscopists with high-level expertise in performing endoscopic submucosal dissection to treat dysplasia and early cancers in the luminal gastrointestinal tract.

American Gastroenterological Association Institute and College of American Pathologists Quality Measure Development for Detection of Mismatch Repair Deficiency and Lynch Syndrome Management

American Gastroenterological Association Institute and College of American Pathologists Quality Measure Development for Detection of Mismatch Repair Deficiency and Lynch Syndrome Management

Evaluating the accuracy of three international guidelines in identifying the risk of malignancy in pancreatic cysts: a retrospective analysis of a surgical treated population.

The international consensus Fukuoka guideline (Fukuoka ICG), The European evidence-based guideline on pancreatic cystic neoplasms (European EBG) and the American Gastroenterological Association institute guideline on the diagnosis and management of asymptomatic neoplastic pancreatic cysts (AGA IG) are 3 frequently cited guidelines for the risk stratification of neoplastic pancreatic cysts. The aim of this study was to assess the accuracy of detecting malignant cysts by strictly applying these guidelines retrospectively to a cohort of surgically resected pancreatic cysts. 72 resected cysts were included in the analysis. Invasive carcinoma, high grade dysplasia and neuro-endocrine tumour were considered as "malignant cysts" for the purpose of the study. 32% of the resected cysts were malignant. The analysis showed that the Fukuoka ICG, European EBG and AGA IG had a sensitivity of 66,8%, 95,5%, 80%; a specificity of 26,8%, 11,3%, 43,8%; a positive predictive value of 31,8%, 35%, 47,1% and a negative predicted value of 61,1%, 83,3%, 77,8% respectively. The missed malignancy rate was respectively 11,3%, 1,5%, 7,7% and surgical overtreatment was respectively 48,4%, 59,1%, 34,6%. In this retrospective analysis, the European EBG had the lowest rate of missed malignancy at the expense of a high number of "unnecessary" resections. The Fukuoka ICG had the highest number of missed malignancy. The AGA IG showed the lowest rate of unnecessary surgery at the cost of a high number of missed malignancy. There is need to develop better biomarkers to predict the risk of malignancy.

Annals for Educators - June 2021.

Annals for Educators - June 2021.

Guidelines on Pancreatic Cystic Neoplasms: Major Inconsistencies With Available Evidence and Clinical Practice— Results From an International Survey

Guidelines on Pancreatic Cystic Neoplasms: Major Inconsistencies With Available Evidence and Clinical Practice— Results From an International Survey

Pediatric Endoscopy During the COVID-19 Pandemic: Implications of Universal Preprocedural Testing for PPE Utilization.

Pediatric Endoscopy During the COVID-19 Pandemic: Implications of Universal Preprocedural Testing for PPE Utilization.

American Gastroenterological AssociationInstitute Guidelineon the MedicalManagement

This report presents the authority recommendations of the American Gastroenterological Association (AGA) Institute on the clinical administration of microscopiccolitis. The rule was created by the AGA Clinical Guidelines Committee and supported by the AGA Governing Board. It is joined by a specialized audit that is a compilation of clinical proof from which these recommendations were formulated. Microscopic colitis is described by constant watery diarrhea brought about by irritation in the colon and diagnosed by colonic biopsy. With a preference for those 60 years of age or more seasoned, it includes 2 subtypes, lymphocytic colitis and collagenous colitis; there is a female prevalence in the last mentioned. The announced common ness of tiny colitis ranges from 48 to 219 for each 100,000. Microscopic colitis is not related with expanded mortality, despite the fact that symptoms can lead to impeded personal satisfaction. Not at all like other inflamma conservative colitides, there is no proof that the constancy of histological aggravation predicts long haul unfavourable out comes like colorectal malignant growth or need for surgery. Accordingly, the objective of clinical treatment reflected in these recommendations is to soothe manifestations and improve quality of life while limiting medication related antagonistic effects. Because results didn't vary among lymphocytic colitis and collagenous colitis in the specialized survey, the recommendations in this rule don't distinguish between subtypes of minuscule colitis.

AGA Institute Quality Measure Development for the Diagnosis and Management of COVID-19

AGA Institute Quality Measure Development for the Diagnosis and Management of COVID-19

AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy

AGA Institute Rapid Review and Recommendations on the Role of Pre-Procedure SARS-CoV-2 Testing and Endoscopy

AGA Clinical Practice Update on Endoscopic Therapies for Non-Variceal Upper Gastrointestinal Bleeding: Expert Review

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update is to review the available evidence and best practice advice statements regarding the use of endoscopic therapies in treating patients with non-variceal upper gastrointestinal bleeding. This expert review was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology. This review is framed around the 10 best practice advice points agreed upon by the authors, which reflect landmark and recent published articles in this field. This expert review also reflects the experiences of the authors who are gastroenterologists with extensive experience in managing and teaching others to treat patients with non-variceal upper gastrointestinal bleeding (NVUGIB). BEST PRACTICE ADVICE 1: Endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB. BEST PRACTICE ADVICE 2: Initial management of the patient with NVUGIB should focus on resuscitation, triage, and preparation for upper endoscopy. After stabilization, patients with NVUGIB should undergo endoscopy with endoscopic treatment of sites with active bleeding or high-risk stigmata for rebleeding. BEST PRACTICE ADVICE 3: Endoscopists should be familiar with the indications, efficacy, and limitations of currently available tools and techniques for endoscopic hemostasis, and be comfortable applying conventional thermal therapy and placing hemoclips. BEST PRACTICE ADVICE 4: Monopolar hemostatic forceps with low-voltage coagulation can be an effective alternative to other mechanical and thermal treatments for NVUGIB, particularly for ulcers in difficult locations or those with a rigid and fibrotic base. BEST PRACTICE ADVICE 5: Hemostasis using an over-the-scope clip should be considered in select patients with NVUGIB, in whom conventional electrosurgical coagulation and hemostatic clips are unsuccessful or predicted to be ineffective. BEST PRACTICE ADVICE 6: Hemostatic powders are a noncontact endoscopic option that may be considered in cases of massive bleeding with poor visualization, for salvage therapy, and for diffuse bleeding from malignancy. BEST PRACTICE ADVICE 7: Hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement. BEST PRACTICE ADVICE 8: Endoscopists should understand the risk of bleeding from therapeutic endoscopic interventions (eg, endoluminal resection and endoscopic sphincterotomy) and be familiar with the endoscopic tools and techniques to treat intraprocedural bleeding and minimize the risk of delayed bleeding. BEST PRACTICE ADVICE 9: In patients with endoscopically refractory NVUGIB, the etiology of bleeding (peptic ulcer disease, unknown source, post surgical); patient factors (hemodynamic instability, coagulopathy, multi-organ failure, surgical history); risk of rebleeding; and potential adverse events should be taken into consideration when deciding on a case-by-case basis between transcatheter arterial embolization and surgery. BEST PRACTICE ADVICE 10: Prophylactic transcatheter arterial embolization of high-risk ulcers after successful endoscopic therapy is not encouraged.

Probiotics: Promise, Evidence, and Hope

Probiotics: Promise, Evidence, and Hope

AGA Clinical Practice Update on Pancreas Cancer Screening in High-Risk Individuals: Expert Review

The purpose of this American Gastroenterological Association Institute Clinical Practice Update is to describe the indications for screening for pancreas cancer in high-risk individuals. The evidence reviewed in this work is based on reports of pancreas cancer screening studies in high-risk individuals and expert opinion. BEST PRACTICE ADVICE 1: Pancreas cancer screening should be considered in patients determined to be at high risk, including first-degree relatives of patients with pancreas cancer with at least 2 affected genetically related relatives. BEST PRACTICE ADVICE 2: Pancreas cancer screening should be considered in patients with genetic syndromes associated with an increased risk of pancreas cancer, including all patients with Peutz-Jeghers syndrome, hereditary pancreatitis, patients with CDKN2A gene mutation, and patients with 1 or more first-degree relatives with pancreas cancer with Lynch syndrome, and mutations in BRCA1, BRCA2, PALB2, and ATM genes. BEST PRACTICE ADVICE 3: Genetic testing and counseling should be considered for familial pancreas cancer relatives who are eligible for surveillance. A positive germline mutation is associated with an increased risk of neoplastic progression and may also lead to screening for other relevant associated cancers. BEST PRACTICE ADVICE 4: Participation in a registry or referral to a pancreas Center of Excellence should be pursued when possible for high-risk patients undergoing pancreas cancer screening. BEST PRACTICE ADVICE 5: Clinicians should not screen average-risk individuals for pancreas cancer. BEST PRACTICE ADVICE 6: Pancreas cancer screening in high-risk individuals should begin at age 50 years, or 10 years younger than the initial age of familial onset. Screening should be initiated at age 40 years in CKDN2A and PRSS1 mutation carriers with hereditary pancreatitis and at age 35 years in the setting of Peutz-Jeghers syndrome. BEST PRACTICE ADVICE 7: Magnetic resonance imaging and endoscopic ultrasonography (EUS) should be used in combination as the preferred screening modalities in individuals undergoing pancreas cancer screening. BEST PRACTICE ADVICE 8: The target detectable pancreatic neoplasms are resectable stage I pancreatic ductal adenocarcinoma and high-risk precursor neoplasms, such as intraductal papillary mucinous neoplasms with high-grade dysplasia and some enlarged pancreatic intraepithelial neoplasias. BEST PRACTICE ADVICE 9: Screening intervals of 12 months should be considered when there are no concerning pancreas lesions, with shortened intervals and/or the performance of EUS in 6-12 months directed towards lesions determined to be low risk (by a multidisciplinary team). EUS evaluation should be performed within 3-6 months for indeterminate lesions and within 3 months for high-risk lesions, if surgical resection is not planned. New-onset diabetes in a high-risk individual should lead to additional diagnostic studies or change in surveillance interval. BEST PRACTICE ADVICE 10: Decisions regarding therapy directed towards abnormal findings detected during screening should be made by a dedicated multidisciplinary team together with the high-risk individual and their family. BEST PRACTICE ADVICE 11: Surgical resection should be performed at high-volume centers. BEST PRACTICE ADVICE 12: Clinicians should consider discontinuing pancreas cancer screening in high-risk individuals when they are more likely to die of non-pancreas cancer-related causes due to comorbidity and/or are not candidates for pancreas resection. BEST PRACTICE ADVICE 13: The limitations and potential risks of pancreas cancer screening should be discussed with patients before initiating a screening program.

AGA Clinical Practice Update on Management of Inflammatory Bowel Disease During the COVID-19 Pandemic: Expert Commentary

The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update was to rapidly review the emerging evidence and provide timely expert recommendations regarding the management of patients with inflammatory bowel disease during the coronavirus disease 2019 pandemic. This expert commentary was commissioned and approved by the AGA Institute Clinical Practice Updates Committee and the AGA Governing Board to provide timely perspective on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the Clinical Practice Updates Committee and external peer review through standard procedures of Gastroenterology.

AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic

Abbreviations used in this paper AGAAmerican Gastroenterological AssociationCDCCenters for Disease Control and PreventionCIconfidence intervalCOVID-19coronavirus disease 2019GIgastrointestinalGRADEGrading of Recommendations Assessment, Development and EvaluationMERS-CoVMiddle East respiratory syndrome–related coronavirusORodds ratioPAPRpowered air-purifying respiratorPPEpersonal protective equipmentRRrisk ratioSARS-CoV-2severe acute respiratory syndrome coronavirus 2WHOWorld Health Organization

Clinical Guideline Highlights for the Hospitalist: Initial Management of Acute Pancreatitis in the Hospitalized Adult.

2018 American Gastroenterological Association (AGA) Institute Guideline on Initial Management of Acute Pancreatitis RELEASE DATE: March 2018 PRIOR VERSION: Not applicable DEVELOPER: AGA Clinical Practice Guideline Committee FUNDING SOURCE: AGA Institute TARGET POPULATION: Patients within first 48-72 hours of admission with acute pancreatitis (AP).

Alcoholic Liver Disease: Implications for the Advanced Practice Provider

Alcoholic liver disease is a largely preventable condition that contributes to mortality in the United States and worldwide. This article discusses the pathogenesis, risk factors, diagnosis, screening tools, clinical presentation, and predictors of mortality. Medical management using the most recent clinical guidelines from the 2018 American College of Gastroenterology and the American Gastroenterological Association Institute are reviewed. Supportive care, abstinence promotion, cognitive behavioral therapy, nutritional needs, pharmacotherapy, alcohol withdrawal management, intensive care, and liver transplantation are discussed, as well as future research directions. Finally, practice implications to better address this population’s needs using a multidisciplinary approach are addressed.

P431 Validation of a therapeutic drug monitoring test to measure the adalimumab biosimilar SB5 in comparison with the reference adalimumab

Validation of therapeutic drug monitoring (TDM) tests is an essential requirement for using these tools to help assess reasons for non-response. The arrival of biosimilars has prompted a need to validate that existing TDM tests are suitable to determine drug levels for all versions of a given molecule. The adalimumab (ADL) biosimilar SB5 (IMRALDI®, Biogen) was authorised by the European Commission in August 2017, and has recently become available for prescription in several European countries. Promonitor®-ADL test is routinely used to monitor IBD patients treated with ADL. In this study, we validated the suitability and performance of Promonitor-ADL CE-marked TDM test for quantifying SB5 serum concentrations in comparison to reference adalimumab (HUMIRA®, Abbvie). The study evaluated imprecision and bias applied to the reference ADL and SB5 biosimilar. The validation study was in line with the design requirements established in the Clinical and Laboratory Standards Institute (CLSI) guideline EP10-A3 for the determination of imprecision and bias. Imprecision was evaluated using three replicates of five human serum sample matrices representative of clinically relevant ADL concentrations and spanning the measurement range of Promonitor-ADL.1 Validations were ran on one instrument with one kit lot by one operator over six non-consecutive operating days and one run per testing day, with an acceptance criterium of CV% ≤20%. The Lower Limit of Quantification (LLOQ) of Promonitor-ADL was determined according to CLSI guideline EP17-A2. The imprecision of Promonitor-ADL was calculated by estimating the components of variance due to within-run and between-day factors meet the accuracy goals proposed at all concentration levels of SB5 vs. HUMIRA (CV% between 5% and 12%). The assessment of accuracy showed that Promonitor-ADL equally measures the active moiety of HUMIRA or SB5. The test is able to quantify SB5 in the measurement range of 0.9 to 10.9 μg/ml with a bias estimate of −0.124 (1%) to 0.897 (10%) μg/ml and an overall imprecision of 5% to 11%. The measurement range includes the recommended clinical decision points. LLOQ of the test to determine ADL was determined to be 0.36 μg/ml. This study demonstrates that Promonitor-ADL test can measure either the reference ADL drug or the biosimilar SB5 (IMRALDI) with equivalent sensitivity, precision and accuracy. Reference 1. Feuerstein JD, Nguyen GC, Kupfer SS, et al. American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. Gastroenterology 2017;153:827–34.

Reactivation risk of Hepatitis B Virus in both HBsAg negative and HBcIgG positive patients with solid malignancy. Is antiviral prophylaxis really necessary?

Prophylactic antiviral treatment is controversial due to a lack of studies in both HBsAg negative/HBcIgG positive patients who treated conventional chemotherapy with solid malignancy, unlike HBsAg positive. In this cross-sectional and retrospective study, we analyzed that the reactivation risk of Hepatitis B Virus (HBVr) of totally 457 HBcIgG positive patients with solid cancer in archives records between 2011 and 2018 years of two different centers. Totally 217 HBcIgG positive patients with solid cancer were included in the study. Anti-HBs positive and negative patients were 119 (54.8%) and 98 (45.2%), respectively. Frequent diagnosis of the patients was lung (28.1%), colorectal (19.4%), breast (17.5%) and hepatobiliary tract cancers (8.3%), respectively. Most of the study population had stage 4 disease (48.8%) and received palliative chemotherapy. When the patients were stratified due to American Gastroenterological Association Institute (AGA) guideline, HBVr risk of chemo regimen was moderate in 21 patients (17.5%), low in 8 patients (3.7%). The majority of the patients were undefined risk group (78.8%). We did not determine any HBVr in the patients who have received different conventional chemotherapy regimens and have different primer tumor site despite all the patients did not receive the prophylactic antiviral drug.