DEVELOPMENT OF AN AUTOMATED ALGORITHM TO GENERATE GUIDELINE-BASED RECOMMENDATIONS FOR FOLLOW-UP COLONOSCOPY.

Abstract: Physician adherence to published colonoscopy surveillance guidelines varies. We aimed to develop and validate an automated clinical decision support algorithm that can extract procedure and pathology data from the […]

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CANADIAN ASSOCIATION OF GASTROENTEROLOGY CLINICAL PRACTICE GUIDELINE ON THE MANAGEMENT OF BILE ACID DIARRHEA.

Abstract: Chronic diarrhea affects about 5% of the population overall. Altered bile acid metabolism is a common but frequently undiagnosed cause.We performed a systematic search of publication databases for studies […]

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Effects of Family History on Relative and Absolute Risks for Colorectal Cancer: a Systematic Review and Meta-Analysis.

Abstract: Guidelines recommend individuals with familial colorectal cancer (FCC) to undergo colonoscopy surveillance instead of average-risk screening. However, these recommendations vary widely. To substantiate appropriate surveillance strategies, precise and valid […]

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Association Between Indefinite Dysplasia and Advanced Neoplasia in Patients With Inflammatory Bowel Diseases Undergoing Surveillance.

Abstract: Little is known about the clinical significance of indefinite dysplasia (IND) in patients with inflammatory bowel diseases (IBD) undergoing colonoscopic surveillance for colorectal neoplasia.We conducted a retrospective cohort analysis […]

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How to select patients for antireflux surgery? The ICARUS guidelines (international consensus regarding preoperative examinations and clinical characteristics assessment to select adult patients for antireflux surgery).

Abstract: Antireflux surgery can be proposed in patients with GORD, especially when proton pump inhibitor (PPI) use leads to incomplete symptom improvement. However, to date, international consensus guidelines on the […]

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British Society of Gastroenterology guidelines for oesophageal manometry and oesophageal reflux monitoring.

These guidelines on oesophageal manometry and gastro-oesophageal reflux monitoring supersede those produced in 2006. Since 2006 there have been significant technological advances, in particular, the development of high resolution manometry (HRM) and oesophageal impedance monitoring. The guidelines were developed by a guideline development group of patients and representatives of all the relevant professional groups using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. A systematic literature search was performed and the GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool was used to evaluate the quality of evidence and decide on the strength of the recommendations made. Key strong recommendations are made regarding the benefit of: (i) HRM over standard manometry in the investigation of dysphagia and, in particular, in characterising achalasia, (ii) adjunctive testing with larger volumes of water or solids during HRM, (iii) oesophageal manometry prior to antireflux surgery, (iv) pH/impedance monitoring in patients with reflux symptoms not responding to high dose proton pump inhibitors and (v) pH monitoring in all patients with reflux symptoms responsive to proton pump inhibitors in whom surgery is planned, but combined pH/impedance monitoring in those not responsive to proton pump inhibitors in whom surgery is planned. This work has been endorsed by the Clinical Services and Standards Committee of the British Society of Gastroenterology (BSG) under the auspices of the oesophageal section of the BSG.

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Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.

In 2016, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released revised EMA and new FDA draft guidelines related to the development of drugs intended for the treatment of ulcerative colitis. We sought to compare and contrast the EMA draft guideline with the FDA draft guidance to facilitate further discussion and perhaps harmonization between the 2 guidelines when they are finalized.A concordance document was created by arranging like or similar topics addressed by the guidelines side by side in a tabular format. This concordance table served as a source for writing the narrative. The first draft was subjected to repeated rounds of reviews and revisions by the authors and outside reviewers, all of them familiar with the subject matter from a regulatory science and/or academic perspective.The FDA guidance focuses on end points, whereas the EMA guideline additionally supplies much useful information for trial design. FDA guidance appears more aspirational, suggesting the development of entirely new patient-reported outcome instruments and the incorporation of a not-yet-validated histology instrument into the definition of mucosal healing.The guidelines by the FDA and the EMA complement each other and together are aimed to further practical drug development toward more clinically relevant end points in ulcerative colitis. Efforts are needed to harmonize the documents.

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Factors Associated With Adherence to Helicobacter pylori Testing During Hospitalization for Bleeding Peptic Ulcer Disease.

Guidelines recommend testing patients with peptic ulcer disease for Helicobacter pylori infection. We sought to identify factors associated with adherence to testing for H pylori in patients hospitalized for bleeding ulcers and to evaluate whether performing these tests affect risk for rebleeding.We performed a retrospective study of 830 inpatients who underwent endoscopy from 2011 through 2016 for gastrointestinal bleeding from gastric or duodenal ulcers. We searched electronic medical records for evidence of tests to detect H pylori by biopsy, serologic, or stool antigen analyses. We used multivariable models to identify clinical, demographic, and endoscopic factors associated with testing for H pylori. Kaplan-Meier analysis was performed to determine whether H pylori testing altered risk for the composite outcome of rebleeding or death within 1 year of admission.Among the patients hospitalized for bleeding peptic ulcer disease during the 6-year period, 19% were not tested for H pylori within 60 days of index endoscopy. Hospitalization in the intensive care unit (ICU) was the factor most frequently associated with nonadherence to H pylori testing guidelines (only 66% of patients in the ICU were tested vs 90% of patients not in the ICU; P<.01), even after we adjusted for ulcer severity, coagulation status, extent of blood loss, and additional factors (adjusted odds ratio, 0.42, 95% CI 0.27-0.66). Testing for H pylori was associated with a 51% decreased risk of rebleeding or death during the year after admission (adjusted hazard ratio 0.49; 95% CI 0.36-0.67).In an analysis of hospitalized patients who underwent endoscopy for gastrointestinal bleeding from gastric or duodenal ulcers, we found admission to the ICU to be associated with failure to test for H pylori infection. Failure to test for H pylori was independently associated with increased risk of rebleeding or death within 1 year of hospital admission. We need strategies to increase testing for H pylori among inpatients with bleeding ulcers.

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Pancreatic neuroendocrine tumors.

Pancreatic neuroendocrine tumors (pNETs) are a rare, heterogeneous group of pancreatic neoplasms with a wide range of malignant potential. They may manifest as noninfiltrative, slow-growing tumors, locally invasive masses, or even swiftly metastasizing cancers.In recent years, because of the increasing amount of scientific literature available for pNETs, the classification, prognostic stratification criteria, and available consensus guidelines for diagnosis and therapy have been revised and updated.The vast majority of new pNET diagnoses consist of incidentally discovered lesions on cross-sectional imaging. The biologic behavior of pNETs is defined by the grade and stage of the tumor. Surgery is the only curative treatment and it, therefore, represents the first therapeutic choice for any localized pNET; however, recent evidence suggests that patients with small (<2?cm), nonfunctioning G1 tumors can be safely observed.An aggressive surgical approach towards liver metastases is recommended in selected cases, as well as liver-directed therapies for disease control. In the presence of unresectable progressive disease, somatostatin analogs, targeted therapies such as everolimus, peptide receptor radionuclide therapy, and systemic chemotherapy are all useful tools for prolonging survival.

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Diagnosis and management of pancreatic cystic neoplasms.

This review outlines the current classification of pancreatic cystic lesions, with a particular emphasis on pancreatic cystic neoplasms (PCNs). It will describe the diagnostic approach to PCNs, with reference to clinicopathological features, cross-sectional radiology and endoscopic ultrasound. This review will conclude with an evidence-based discussion of the management of PCNs focused on recent clinical guidelines.

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Practical guide to the management of acute pancreatitis.

Acute pancreatitis (AP) is characterised by inflammation of the exocrine pancreas and is associated with acinar cell injury and both a local and systemic inflammatory response. AP may range in severity from self-limiting, characterised by mild pancreatic oedema, to severe systemic inflammation with pancreatic necrosis, organ failure and death. Several international guidelines have been developed including those from the joint International Association of Pancreatology and American Pancreatic Association, American College of Gastroenterology and British Society of Gastroenterology. Here we discuss current diagnostic and management challenges and address the common dilemmas in AP.

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Guideline review: British Society of Gastroenterology/UK-PBC Primary Biliary Cholangitis treatment and management guidelines.

New guidelines have been produced for the management of primary biliary cholangitis, an infrequent but nonetheless important autoimmune liver disease. We provide a succient commentary and overview of the key features of disease management that arise from these recent guideline recommendations, with a focus on therapy with licensed agents (ursodeoxycholic acid and obeticholic acid) as well as personalised management of disease complications and associated symptoms.

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British Society of Gastroenterology guidelines on the diagnosis and management of patients at risk of gastric adenocarcinoma.

Gastric adenocarcinoma carries a poor prognosis, in part due to the late stage of diagnosis. Risk factors include Helicobacter pylori infection, family history of gastric cancer-in particular, hereditary diffuse gastric cancer and pernicious anaemia. The stages in the progression to cancer include chronic gastritis, gastric atrophy (GA), gastric intestinal metaplasia (GIM) and dysplasia. The key to early detection of cancer and improved survival is to non-invasively identify those at risk before endoscopy. However, although biomarkers may help in the detection of patients with chronic atrophic gastritis, there is insufficient evidence to support their use for population screening. High-quality endoscopy with full mucosal visualisation is an important part of improving early detection. Image-enhanced endoscopy combined with biopsy sampling for histopathology is the best approach to detect and accurately risk-stratify GA and GIM. Biopsies following the Sydney protocol from the antrum, incisura, lesser and greater curvature allow both diagnostic confirmation and risk stratification for progression to cancer. Ideally biopsies should be directed to areas of GA or GIM visualised by high-quality endoscopy. There is insufficient evidence to support screening in a low-risk population (undergoing routine diagnostic oesophagogastroduodenoscopy) such as the UK, but endoscopic surveillance every 3?years should be offered to patients with extensive GA or GIM. Endoscopic mucosal resection or endoscopic submucosal dissection of visible gastric dysplasia and early cancer has been shown to be efficacious with a high success rate and low rate of recurrence, providing that specific quality criteria are met.

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Patients Eligible for Trials of Microbe-based Therapeutics do not Represent the Population With Recurrent Clostridioides difficile Infection.

Although there are many industry-funded trials of microbe-based therapeutics for Clostridioides (formerly Clostridium) difficile infection (CDI), not all patients are eligible for these trials, due to their strict enrollment criteria. Furthermore, given the widespread availability of fecal microbiota transplantation (FMT) and overwhelming evidence to support its efficacy, patients might refuse enrollment in trials with a placebo group. We analyzed willingness and eligibility of patients with recurrent CDI to participate in randomized controlled trials of microbe-based therapeutic agents.We performed a retrospective study of 199 patients referred to 4 tertiary referral centers for treatment of CDI from August 1, 2018 through January 31, 2019. We collected data on eligibility for FMT and enrollment in randomized controlled trials.Of 130 patients deemed appropriate for FMT, 98 patients (75%) were ineligible for participation in a randomized controlled trial and 16 patients (17%) were eligible but refused to enroll. Immune compromise and inflammatory bowel diseases were the most common reasons for exclusion from trials CONCLUSIONS: Most patients with CDI who meet the guideline criteria for FMT are ineligible or unwilling to participate in randomized controlled trials of microbe-based therapeutics. Trial populations therefore do not represent the population of patients with CDI.

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Early initiation of antiviral therapy contributes to a rapid and significant loss of serum HBsAg in infantile-onset hepatitis B.

There is a paucity of data regarding antiviral therapy in hepatitis B virus (HBV)-infected infants aged <1 year with elevated ALT. This study aims to assess the efficacy and safety of antiviral therapy initiated in infancy.A real-world cohort study was conducted from January 2010 to December 2017. HBV-infected infants with persistent elevation of ALT and high viral load under 1 year of age were recruited and divided into 2 groups. Group I included 18 infants whose parents chose to initiate antiviral therapy with lamivudine before 1 year of age. Group II included 11 infants whose parents chose to initiate antiviral therapy with interferon-? after 1 year of age and not to receive any antiviral therapies before 1 year of age.The main outcome measure was rate of serum HBsAg loss at month 12 of treatment.There were no statistical differences between Groups I and II regarding baseline characteristics. No infants in Group II developed spontaneous HBsAg loss before 1 year of age. In Group I, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were respectively 39%, 67%, 78% and 83%. In Group II, the cumulative rates of HBsAg loss at month 3, 6, 9 and 12 of treatment were respectively 18%, 27%, 27% and 36%. Statistical differences existed in the cumulative rates of HBsAg loss between the two groups (log-rank test, P=0.0023). No serious adverse events occurred in the study.Early initiation of antiviral therapy contributes to a rapid and significant loss of HBsAg for infantile-onset hepatitis B. Further trials with larger cohorts are needed to verify our results.Chronicity is a serious threat to infantile hepatitis B. However, no treatment measure has been recommended for infants with onset hepatitis B in current guidelines. In order to evaluate the benefit and safety of antiviral therapy in infantile-onset hepatitis B, a real-world cohort study was conducted. Long-term follow-up results showed that early initiation of antiviral therapy with lamivudine safely led to a rapid and significant loss of serum HBsAg in the present subset of infants with ALT >=2 times upper limit of normal. Further trials with larger cohorts are needed.

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Clinical and Pathological Characterization of Lynch-Like Syndrome.

Lynch syndrome is characterized by DNA mismatch repair (MMR) deficiency. Some patients with suspected Lynch syndrome have DNA MMR deficiencies but no detectable mutations in genes that encode MMR proteins-this is called Lynch-like syndrome (LLS). There is no consensus on management of patients with LLS. We collected data from a large series of patients with LLS to identify clinical and pathology features.We collected data from a nationwide-registry of patients with colorectal cancer (CRC) in Spain. We identified patients whose colorectal tumors had loss of MSH2, MSH6, PMS2, or MLH1 (based on immunohistochemistry), without the mutation encoding V600E in BRAF (detected by real-time PCR), and/or no methylation at MLH1 (determined by methylation-specific multiplex ligation-dependent probe amplification), and no pathogenic mutations in MMR genes, BRAF, or EPCAM (determined by DNA sequencing). These patients were considered to have LLS. We collected data on demographic, clinical, and pathology features and family history of neoplasms. The ?2 test was used to analyze the association between qualitative variables, followed by the Fisher exact test and the Student t test or the Mann-Whitney test for quantitative variables.We identified 160 patients with LLS; their mean age at diagnosis of CRC was 55 years and 66 patients were female (41%). The Amsterdam I and II criteria for Lynch syndrome were fulfilled by 11% of cases and the revised Bethesda guideline criteria by 65% of cases. Of the patients with LLS, 24% were identified in universal screening. There were no proportional differences in sex, indication for colonoscopy, immunohistochemistry, pathology findings, or personal history of CRC or other Lynch syndrome-related tumors between patients who met the Amsterdam and/or Bethesda criteria for Lynch syndrome and patients identified in universal screening for Lynch syndrome, without a family history of CRC.Patients with LLS have homogeneous clinical, demographic, and pathology characteristics, regardless of family history of CRC.

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Optimal Timing of Total Gastrectomy to Prevent Diffuse Gastric Cancer in Individuals with Pathogenic Variants in CDH1.

Carriers of pathogenic variants in CDH1 have a high risk of hereditary diffuse gastric cancer (HDGC). Guidelines recommend prophylactic total gastrectomy (PTG) at age 20-30 years, although there is controversy over the optimal age. We developed a simulation model to analyze the effects of PTG at different ages on quality-adjusted life-years (QALYs), cancer mortality, and life expectancy.We used a Markov model of HDGC progression associated with pathogenic variants in CDH1 to simulate outcomes of hypothetical cohorts with different ages at time of PTG (ages 20-79 years). Model inputs including health state transition probabilities, mortality and complication rates, quality of life utility values, and endoscopic surveillance sensitivity were derived from publications. The primary outcome, used to determine the optimal strategy, was age at which PTG yielded the highest QALYs. Secondary outcomes were cancer mortality and unadjusted life-years.Our model found that for men, the optimal age for PTG is 39 years, resulting in 32.01 incremental QALYs, 58.81 life-years (biologic age, 72.81 years), and lifetime cancer mortality of 8.5%. Incorporating endoscopic surveillance prior to PTG decreased cancer mortality to 6.7%, but had lower QALYs (31.59). PTG at age 30 reduced cancer mortality to 3.2%, with 31.45 incremental QALYs. For women, the optimal age for PTG was calculated to be 30 years, with 33.09 incremental QALYs, 66.17 life-years (biologic age, 80.17 years), and lifetime cancer mortality of 1.6%. Addition of endoscopic surveillance did not decrease the risk of HDGC mortality in women.Using a Markov model of HDGC progression associated with pathogenic variants in CDH1 to simulate outcomes, we found the optimal ages for PTG to be 39 years for men and 30 years for women, when QALYs are the primary endpoint. These ages for PTG are older than those of current recommendations.

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Pancreatic cystic lesions: risk stratification and management based on recent guidelines.

Pancreatic cystic lesions (PCLs) can present complex diagnostic and management challenges with uncertainty as to the most appropriate investigations, interventions and surveillance. Guidelines have been developed to aid decision making, including the European Study Group, American College of Gastroenterology and International Study Group guidelines. This paper presents issues relating to risk stratification and the appropriate management of patients with PCLs, reviewing these recently published guidelines. While there are similarities across these expert guidelines, there are notable differences in terms of features associated with increased risk of malignant transformation, the most appropriate imaging modality and timing of interval imaging. Where variations exist, this reflects differing interpretations of a limited evidence base, and decision making will likely evolve further as experience with these guidelines develops.

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Management of benign oesophageal strictures.

Benign oesophageal strictures are an important gastrointestinal condition that can cause substantial morbidity. There are many different aetiologies and each case needs careful evaluation and individualised treatment. Management usually involves targeting therapy to the underlying cause, but oesophageal dilatation is an important part of the algorithm. The recent British Society of Gastroenterology guidelines provide advice on the use of dilatation for benign strictures and cover patient preparation, the dilatation procedure and disease-specific considerations. This article provides a summary of the key messages from the guidelines and applies them to routine clinical practice. It also includes practical advice on the clinical assessment, investigation and management of benign oesophageal strictures and gives an approach to the management of refractory strictures. Areas where evidence is sparse and further research is needed are highlighted.

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Optimising the use of small bowel endoscopy: a practical guide.

The wireless nature of capsule endoscopy offers patients the least invasive option for small bowel investigation. It is now the first-line test for suspected small bowel bleeding. Furthermore meta-analyses suggest that capsule endoscopy outperforms small bowel imaging for small bowel tumours and is equivalent to CT enterography and magnetic resonance enterography for small bowel Crohn’s disease. A positive capsule endoscopy lends a higher diagnostic yield with device-assisted enteroscopy. Device-assisted enteroscopy allows for the application of therapeutics to bleeding points, obtain histology of lesions seen, tattoo lesions for surgical resection or undertake polypectomy. It is however mainly reserved for therapeutics due to its invasive nature. Device-assisted enteroscopy has largely replaced intraoperative enteroscopy. The use of both modalities is discussed in detail for each indication. Current available guidelines are compared to provide a concise review.

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Dedicated service improves the accuracy of Barrett’s oesophagus surveillance: a prospective comparative cohort study.

Standards for Barrett’s oesophagus (BO) surveillance in the UK are outlined in the British Society of Gastroenterology (BSG) guidelines. This study aimed to assess the quality of current surveillance delivery compared with a dedicated service.All patients undergoing BO surveillance between January 2016 and July 2017 at a single National Health Service district general hospital were included. Patients had their endoscopy routed to a dedicated BO endoscopy list or a generic service list. Prospective data were analysed against the BSG guidelines and also compared with each patient’s prior surveillance endoscopy.361 patients were scheduled for surveillance of which 217 attended the dedicated list, 78 attended the non-dedicated list and 66 did not have their endoscopy. The dedicated list adhered more closely to the BSG guidelines when compared with the non-dedicated and prior endoscopy, respectively; Prague classification (100% vs 87.3% vs 82.5%, p<0.0001), hiatus hernia delineation (100% vs 64.8% vs 63.3%, p<0.0001), location and number of biopsies recorded (99.5% vs 5.6% vs 6.9%, p<0.0001), Seattle protocol adherence (72% vs 42% vs 50%, p<0.0001) and surveillance interval adherence (dedicated 100% vs prior endoscopy 75%, p<0.0001). Histology results from the dedicated and non-dedicated list cohorts revealed similar rates of intestinal metaplasia (79.8% vs 73.1%, p=0.12) and dysplasia/oesophageal adenocarcinoma (4.3% vs 2.6%, p=0.41).The post-BSG guideline era of BO surveillance remains suboptimal in this UK hospital setting. A dedicated service appears to improve the accuracy and consistency of surveillance care, although the clinical significance of this remains to be determined.

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