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The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens.Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L + 2 L) (High-SD) or low volume (1 L + 1 L) + bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates.Over 29 months, 2314 subjects were randomized to High-SD (N = 1157) or Low-SD (N = 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P = .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P.01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P.01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P = .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P.01), a finding not seen in the Low-SD group.Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).

Background and Aim Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the standard of care in advanced pancreatic cancer. Its role in resectable disease, however, is controversial. This meta-analysis aims to ascertain the clinical outcomes of patients with resectable pancreatic cancer undergoing preoperative EUS-FNA compared to those going directly to surgery. Methods A literature search was performed from 1996 to April 2019 using MEDLINE, EMBASE, and ISI Web of Knowledge for studies comparing preoperative EUS-FNA to EUS without FNA in resectable pancreatic cancer for clinical outcomes. The primary outcome is overall survival (OS). Secondary outcomes include cancer-free survival, tumor recurrence and peritoneal carcinomatosis, and post-FNA-pancreatitis rate. Results Six retrospective studies were included. Preoperative EUS-FNA had better OS than the non-FNA group (WMD, 4.40 months [0.02 to 8.78]). Cancer-free survival did not differ significantly between the two groups (WMD, 2.08 months [−2.22 to 6.38]). EUS with FNA was not associated with increased rates of tumor recurrence or peritoneal carcinomatosis. Conclusion Preoperative EUS-FNA in resectable pancreatic cancer may be associated with significantly greater OS when compared to the non-FNA group, with no significant difference in the rates of tumor recurrence or peritoneal seeding. Important limitations of our meta-analysis include the lack of prospective controlled data, which are unlikely to emerge given feasible constraints.

Background Clinical implementation of the resect-and-discard strategy has been difficult because optical diagnosis is highly operator dependent. This prospective study aimed to evaluate a resect-and-discard strategy that is not operator dependent. Methods The study evaluated a resect-and-discard strategy that uses the anatomical polyp location to classify colonic polyps into non-neoplastic or low risk neoplastic. All rectosigmoid diminutive polyps were considered hyperplastic and all polyps located proximally to the sigmoid colon were considered neoplastic. Surveillance interval assignments based on these a priori assumptions were compared with those based on actual pathology results and on optical diagnosis. The primary outcome was ≥ 90 % agreement with pathology in surveillance interval assignment. Results 1117 patients undergoing complete colonoscopy were included and 482 (43.1 %) had at least one diminutive polyp. Surveillance interval agreement between the location-based strategy and pathological findings using the 2020 US Multi-Society Task Force guideline was 97.0 % (95 % confidence interval [CI] 0.96–0.98), surpassing the ≥ 90 % benchmark. Optical diagnoses using the NICE and Sano classifications reached 89.1 % and 90.01 % agreement, respectively (P Conclusion The location-based resect-and-discard strategy achieved very high surveillance interval agreement with pathology-based surveillance interval assignment, surpassing the ≥ 90 % benchmark and outperforming optical diagnosis in surveillance interval agreement and the number of pathology examinations avoided.

Background and study aims Biliary stenting is indicated to relieve obstruction from borderline resectable pancreatic cancer while patients receive preoperative neoadjuvant therapy. We compared the cost-effectiveness of plastic versus metal biliary stenting in this setting. Methods A decision tree analysis compares two competing types of biliary stents (initially metal vs. initially plastic) to treat malignant distal biliary obstruction while receiving neoadjuvant therapy with different scenarios including possible complications as bridge till the patient undergoes curative surgical attempt. Using published information, effectiveness was chosen as the probability of successfully reaching a state of being ready for surgery once chemotherapy was completed. Costs (2018 US$) were based on national data. A third-party payer perspective was adopted, and sensitivity analyses were performed over a time-horizon of one year. Results Initially inserting a metal versus a plastic biliary stent was more efficacious with a higher probability of reaching the readiness for surgery endpoint (96 % vs. 85 %), on average 18 days earlier while also being less expensive (US$ 9,304 vs. US$ 11,538). Sensitivity analyses confirmed robustness of these results across varying probability assumptions of plausible ranges and remained a dominant strategy even when lowering the willingness-to-pay threshold to US$ 1,000. Conclusions Initial metal stenting to relieve malignant biliary obstruction from borderline resectable pancreatic cancer in patients undergoing neoadjuvant therapy prior to surgery is a dominant intervention in economic terms, when compared to initially inserting a plastic biliary stent as it results in a greater proportion of patients being fit for surgery earlier and at a lower cost.

ObjectiveTo determine whether proton pump inhibitors (PPIs) are associated with an increased risk of colorectal cancer, compared with histamine-2 receptor antagonists (H2RAs).DesignThe United Kingdom Clinical Practice Research Datalink was used to identify initiators of PPIs and H2RA from 1990 to 2018, with follow-up until 2019. Cox proportional hazards models were fit to estimate marginal HRs and 95% CIs of colorectal cancer. The models were weighted using standardised mortality ratio weights using calendar time-specific propensity scores. Prespecified secondary analyses assessed associations with cumulative duration, cumulative dose and time since treatment initiation. The number needed to harm was calculated at five and 10 years of follow-up.ResultsThe cohort included 1 293 749 and 292 387 initiators of PPIs and H2RAs, respectively, followed for a median duration of 4.9 years. While the use of PPIs was not associated with an overall increased risk of colorectal cancer (HR: 1.02, 95% CI 0.92 to 1.14), HRs increased with cumulative duration of PPI use (ConclusionWhile any use of PPIs was not associated with an increased risk of colorectal cancer compared with H2RAs, prolonged use may be associated with a modest increased risk of this malignancy.

High-quality evidence guiding optimal transfusion and other supportive therapies to reduce bleeding is needed to improve outcomes for patients with either severe bleeding or hemostatic disorders that are associated with poor outcomes. Alongside challenges in performing high-quality clinical trials in patient populations who are at risk of bleeding or who are actively bleeding, the interpretation of research evaluating hemostatic agents has been limited by inconsistency in the choice of primary trial outcomes. This lack of standardization of primary endpoints or outcomes decreases the ability of clinicians to assess the validity of endpoints and compare research results across studies, impairs meta-analytic efforts, and, ultimately, delays the translation of research results into clinical practice. To address this challenge, an international panel of experts was convened by the National Heart Lung and Blood Institute and the US Department of Defense on September 23 and 24, 2019, to develop expert opinion, consensus-based recommendations for primary clinical trial outcomes for pivotal trials in pediatric and adult patients with six categories in various clinical settings. This publication documents the conference proceedings from the workshop funded by the National Heart Lung and Blood Institute and the US Department of Defense that consolidated expert opinion regarding clinically meaningful outcomes across a wide range of disciplines to provide guidance for outcomes of future trials of hemostatic products and agents for patients with active bleeding.

Background Atypical cellular features are commonly encountered in patients with indeterminate biliary strictures, which are nondiagnostic of malignancy yet cannot rule it out. This study aims to identify clinical features that could discriminate patients with indeterminate biliary strictures and atypical biliary cytology who may harbor underlying malignancy. Methods All patients with an indeterminate biliary stricture and an atypical brush cytology obtained during endoscopic brushings were identified in a large tertiary-care center. Demographical information, clinical data and the final pathological diagnosis were collected. The study cohort was divided based on the final diagnosis into benign and malignant groups. Descriptive and multivariable analyses were performed. Results A total of 151 patients were included in the analysis. Of these, 62.9% were males with mean age of 61.7 ± 16.4 years. Overall, there was an almost equal distribution of patients in the benign and malignant groups. Older age (≥65 years), jaundice, weight loss, intrahepatic biliary and pancreatic duct dilation, double-duct sign and presence of a mass were associated with malignancy in the univariate analysis. However, only older age (odds ratio [OR] 1.02, 95% confidence interval [CI] 1.00 to 1.03), jaundice (OR 3.33, 95% CI 1.11 to 9.98) and presence of a mass (OR 12.10, 95% CI 4.94 to 29.67) were significantly associated with malignancy in the multivariate analysis. High CA19-9 was associated with malignancy only in patients with primary sclerosing cholangitis. Conclusion In patients with indeterminate biliary stricture and atypical brush cytology, older age, jaundice and presence of a mass are significant predictors of malignancy. Patients with such characteristics need prompt evaluation to rule out underlying malignancy.

Background Standard colonoscopy practice requires removal and histological characterization of almost all detected small ( Methods A post hoc analysis was performed on patients enrolled in a prospective study. The primary outcome was surveillance interval agreement of the PBRD strategy with pathology-based management according to 2020 US Multi-Society Task Force guidelines. Chart analysis also evaluated clinician adherence to pathology-based recommendations. One-sided testing was performed with a null-hypothesis of 90 % agreement with pathology-based surveillance intervals and a two-sided 96.7 % confidence interval (CI) using correction for multiple testing. Results 452 patients were included in the study. Surveillance intervals assigned using the PBRD strategy were correct in 97.8 % (96.7 %CI 96.3–99.3 %) of patients compared with pathology-based management. The PBRD strategy reduced pathology examinations by 58.7 % while providing 87.8 % of patients with immediate surveillance interval recommendations on the day of colonoscopy, compared with 47.1 % when using pathology-based management. Chart analysis of surveillance interval assignments showed 63.3 % adherence to pathology-based guidelines. Conclusion The PBRD strategy surpassed the 90 % agreement with the pathology-based standard for determining surveillance interval, reduced the need for pathology examinations, and increased the proportion of patients receiving immediate surveillance interval recommendations. The PBRD strategy does not require expertise in optical diagnosis and may replace histological characterization of small and diminutive colorectal polyps.

Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA + ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions. Methods A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. Results 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA + ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA + ROSE at 92.2 % (95 %CI 86.6 %–96.9 %) and 93.3 % (95 %CI 88.8 %–97.9 %), respectively (P = 0.72). Diagnostic sensitivity for malignancy was 92.5 % (95 %CI 85.7 %–96.7 %) for EUS-FNB alone vs. 96.5 % (93.0 %–98.6 %) for EUS-FNA + ROSE (P = 0.46), while specificity was 100 % in both. Adequate histological yield was obtained in 87.5 % of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [P Conclusion EUS-FNB alone is non-inferior to EUS-FNA + ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.

Background Despite the existing evidence, the omission of antibiotics in the management of acute uncomplicated diverticulitis has not gained widespread acceptance. Objective This study aims to incorporate the input of both patients and physicians on the omission of antibiotics in uncomplicated diverticulitis to generate noninferiority margins for 3 outcomes. Design This was a mixed-methods study, including in-person interviews with patients and a Delphi process with physicians. Settings North American patients and physicians participated. Patients Consecutive patients undergoing colonoscopy, 40% of whom had a previous history of diverticulitis, were selected. Interventions Informational video (for patients) and evidence summaries (for physicians) regarding antibiotics in diverticulitis were reviewed. Main outcomes measures Noninferiority margins were generated for time to reach full recovery, persistent diverticulitis, and progression to complicated diverticulitis in the context of a nonantibiotic strategy. Consensus was defined as an interquartile range Results Fifty patients participated in this study. To avoid antibiotics, patients were willing to accept up to 5.0 (3.0-7.0) days longer to reach full recovery, up to an absolute increase of 4.0% (4.0-6.0) in the risk of developing persistent diverticulitis, and up to an absolute increase of 2.0% (0-3.8) in the risk of progressing to complicated diverticulitis. A total of 55 physicians participated in the Delphi (round 1 response rate = 94.8%; round 2 response rate = 100%). Consensus noninferiority margins were generated for persistent diverticulitis (4.0%, 4.0-5.0) and progression to complicated diverticulitis (3.0%, 2.0-3.0), but could not be generated for time to reach full recovery (5.0 days, 3.5-7.0). Limitations Patients were recruited from a single institution, and Delphi participants were invited and not randomly selected. Conclusion Noninferiority margins were generated for 3 important outcomes after the treatment of acute uncomplicated diverticulitis in the context of a nonantibiotic strategy.

Performance of endoscopic procedures is associated with a risk of infection from COVID-19. This risk can be reduced by the use of personal protective equipment (PPE). However, shortage of PPE has emerged as an important issue in managing the pandemic in both traditionally high and low-resource areas. A group of clinicians and researchers from thirteen countries representing low, middle, and high-income areas has developed recommendations for optimal utilization of PPE before, during, and after gastrointestinal endoscopy with particular reference to low-resource situations. We determined that there is limited flexibility with regard to the utilization of PPE between ideal and low-resource settings. Some compromises are possible, especially with regard to PPE use, during endoscopic procedures. We have, therefore, also stressed the need to prevent transmission of COVID-19 by measures other than PPE and to conserve PPE by reduction of patient volume, limiting procedures to urgent or emergent, and reducing the number of staff and trainees involved in procedures. This guidance aims to optimize utilization of PPE and protection of health care providers.

Gastroesophageal reflux disease (GERD) is a very common worldwide condition, affecting about 15-20% of the whole population, and representing a major burden for health-care systems. Because of its frequency, health physicians - family doctors as well as specialists - should be aware of the different pharmacotherapeutic approaches in managing GERD, according to disease severity.Authors summarize the pharmacological management of GERD in adults, present the different pharmaceutical classes, and review the evidence on efficacy for each treatment according to the most common clinical scenarios: non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE), and proton-pump inhibitor (PPI) refractory GERD. They also provide an overview of treatments under development.To date, PPIs remain the most effective treatment option for both NERD and EE. However, Potassium-Competitive Acid blockers (PCAB) may be considered, with at least similar efficacy in Asian populations. Preliminary data suggest that PCABs could be superior to classic PPIs in patients with severe EE, and may also be of particular interest in the management of PPI-refractory GERD patients. Their definitive role in GERD management, however, still remains to be determined based on properly designed and conducted randomized clinical trials.

Colorectal cancer (CRC) is one of the most common and lethal malignancies in Western countries. Its development is a multistep process that spans more than 15 years, thereby providing an opportunity for prevention and early detection. The high incidence and mortality rates emphasise the need for prevention and screening. Many countries have therefore introduced CRC screening programmes. It is expected, and preliminary evidence in some countries suggests, that this screening effort will decrease CRC-related mortality rates. CRC prevention involves a healthy lifestyle and chemoprevention—more specifically, oral chemoprevention that can interfere with progression from a normal colonic mucosa to adenocarcinoma. This preventive effect is important for individuals with a genetic predisposition, but also in the general population. The ideal chemopreventive agent, or combination of agents, remains unknown, especially when considering safety during long-term use. This review evaluates the evidence across 80 meta-analyses of interventional and observational studies of CRC prevention using medications, vitamins, supplements and dietary factors. This review suggests that the following factors are associated with a decreased incidence of CRC: aspirin, non-steroidal anti-inflammatory drugs, magnesium, folate, a high consumption of fruits and vegetables, fibre and dairy products. An increased incidence of CRC was observed with frequent alcohol or meat consumption. No evidence of a protective effect for tea, coffee, garlic, fish and soy products was found. The level of evidence is moderate for aspirin, β-carotene and selenium, but is low or very low for all other exposures or interventions.

INTRODUCTION Bowel cleanliness has been shown to be superior with split-dose vs nonsplit preparations; we aimed to directly assess the poorly characterized comparative efficacies of split-dose vs same-day polyethylene glycol (PEG) regimens. METHODS In this study, one of a series of randomized trials performed across 10 Canadian endoscopy units, patients undergoing colonoscopies between 10:30 and 16:30 were allocated to PEG low-volume same-day (15 mg bisacodyl the day before, 2 L the morning of the procedure), low-volume split-dose (15 mg bisacodyl the day before, 1 L + 1 L), or high-volume split-dose (2 L + 2 L). Coprimary endpoints were adequate bowel cleansing based on the Boston Bowel Preparation Scale using in turn different threshold cutoffs. RESULTS Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment. Willingness to repeat the preparation was not significantly different between low-volume same-day (91.0%) and low-volume split-dose (92.5%; P = 0.40) but was greater than the high-volume split-dose (68.9%; P < 0.01). No significant differences were noted for withdrawal time, cecal intubation, or polyp detection rates. DISCUSSION In this large randomized trial of PEG regimens, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose.

Background and study aims Optical real-time diagnosis (= resect-and-discard strategy) is an alternative to histopathology for diminutive colorectal polyps. However, clinical adoption of this approach seems sparse. We were interested in evaluating potential clinical uptake and barriers for implementation of this approach. Methods We conducted an international survey using the “Google forms” platform. Nine endoscopy societies distributed the survey. Survey questions measured current clinical uptake and barriers for implementing the resect-and-discard strategy, perceived cancer risk associated with diminutive polyps and potential concerns with using CT-colonography as follow-up, as well as non-resection of diminutive polyps. Results Eight hundred and eight endoscopists participated in the survey. 84.2 % (95 % CI 81.6 %–86.7 %) of endoscopists are currently not using the resect-and-discard strategy and 59.9 % (95 % CI 56.5 %–63.2 %) do not believe that the resect-and-discard strategy is feasible for implementation in its current form. European (38.5 %) and Asian (45 %) endoscopists had the highest rates of resect-and-discard practice, while Canadian (13.8 %) and American (5.1 %) endoscopists had some of the lowest implementation rates. 80.3 % (95 % CI 77.5 %–83.0 %) of endoscopists believe that using the resect-and-discard strategy for diminutive polyps will not increase cancer risk. 48.4 % (95 % CI 45.0 %–51.9 %) of endoscopists believe that leaving diminutive polyps in place is associated with increased cancer risk. This proportion was slightly higher (54.7 %; 95 % CI 53.6 %–60.4 %) when asked if current CT-colonography screening practice might increase cancer risks. Conclusion Clinical uptake of resect-and-discard is very low. Most endoscopists believe that resect-and-discard is not feasible for clinical implementation in its current form. The most important barriers for implementation are fear of making an incorrect diagnosis, assigning incorrect surveillance intervals and medico-legal consequences.

Background Replacing histopathology evaluation of diminutive polyps with optical polyp diagnosis is considered a cost-effective approach. However, the widespread use of optical diagnosis is limited due to concerns about making incorrect optical diagnoses and the requirements of training, credentialing and auditing of performance. Aims This prospective study aimed to evaluate a simplified resect and discard strategy that is not operator dependent. Methods The study evaluated a resect and discard strategy that uses anatomical polyp location to classify colon polyps into non-neoplastic or low-risk neoplastic. All rectosigmoid diminutive polyps were considered hyperplastic and all polyps located proximally to the sigmoid colon were considered neoplastic. Surveillance interval assignments based on these a priori assumptions were compared with those based on actual pathology results and optical diagnosis, respectively. The primary outcome was ≥90% agreement with pathology in surveillance interval assignment. Results Overall, 1117 patients undergoing complete colonoscopy were included and 482 (43.1%) had at least one diminutive polyp. Surveillance interval agreement between the location-based resect and discard strategy and pathological findings using the 2020 US Multi-Society Task Force guideline was 97.0% (95% CI = 0.96 - 0.98), surpassing the ≥90% benchmark. Optical diagnoses using NICE and Sano classifications reached 89.1% and 90.01% agreement, respectively (p Conclusions The location-based resect and discard strategy achieved very high surveillance interval agreement with pathology-based surveillance interval assignment, surpassing the ≥90% quality benchmark and outperforming optical diagnosis in surveillance interval agreement and the number of pathology examinations avoided. Funding Agencies None

Introduction There are conflicting reports on the effects of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) on acute pancreatitis incidence. Objective The aim was to determine whether use of ACE inhibitors and ARBs is associated with the incidence of acute pancreatitis, compared with use of dihydropyridine calcium channel blockers (dCCBs). Methods We assembled two population-based, new-user, active comparator cohorts using the United Kingdom Clinical Practice Research Datalink linked to the Hospital Episode Statistics repository and Office for National Statistics from 1998 to 2018, with follow-up until 2019. The first cohort included 304,083 ACE inhibitor initiators and 194,431 dCCB initiators. The second cohort included 29,160 ARB initiators and 203,610 dCCB initiators. Cox proportional hazards models were fit to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of acute pancreatitis, comparing ACE inhibitors and ARBs, separately, with dCCBs. Models were weighted using standardized mortality ratio weights generated from calendar time-specific propensity scores. Results ACE inhibitors were associated with an increased risk of acute pancreatitis, compared with dCCBs (64.3 vs 45.2 per 100,000 person-years, respectively; HR 1.45, 95% CI 1.15-1.83). The number needed to harm after 2 and 5 years of use was 2438 and 1019, respectively. In contrast, ARBs were not associated with an increased risk of acute pancreatitis, compared with dCCBs (40.1 vs 47.6 per 100,000 person-years, respectively; HR 0.88, 95% CI 0.60-1.31). Conclusions ACE inhibitors were associated with a modest increased risk of acute pancreatitis compared with dCCBs. This association should be balanced with the known clinical benefits of ACE inhibitors in hypertension management. In contrast, no association was observed with ARBs.

Background and aimsPatients infected with the SARS-CoV-2 usually report fever and respiratory symptoms. However, multiple gastrointestinal (GI) manifestations such as diarrhoea and abdominal pain have been described. The aim of this study was to evaluate the prevalence of GI symptoms, elevated liver enzymes and mortality of patients with COVID-19.MethodsA systematic review and meta-analysis of published studies that included a cohort of patients infected with SARS-CoV-2 were performed from 1 December 2019 to 15 December 2020. Data were collected by conducting a literature search using PubMed, Embase, Scopus, and Cochrane according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We analysed pooled data on the prevalence of individual GI symptoms and elevated liver enzymes and performed subanalyses to investigate the relationship between GI symptoms/elevated liver enzymes, geographical location, mortality, and intensive care unit (ICU) admission.ResultsThe available data of 78 798 patients positive for SARS-CoV-2 from 158 studies were included in our analysis. The most frequent manifestations were diarrhoea (16.5%, 95% CI 14.2% to 18.4%), nausea (9.7%, 95% CI 9.0% to 13.2%) and elevated liver enzymes (5.6%, 95% CI 4.2% to 9.1%). The overall mortality and GI mortality were 23.5% (95% CI 21.2% to 26.1%) and 3.5% (95% CI 3.1% to 6.2%), respectively. Subgroup analysis showed non-statistically significant associations between GI symptoms/elevated liver enzymes and ICU admissions (OR=1.01, 95% CI 0.55 to 1.83). The GI mortality was 0.9% (95% CI 0.5% to 2.2%) in China and 10.8% (95% CI 7.8% to 11.3%) in the USA.ConclusionGI symptoms/elevated liver enzymes are common in patients with COVID-19. Our subanalyses showed that the presence of GI symptoms/elevated liver enzymes does not appear to affect mortality or ICU admission rate. Furthermore, the proportion of GI mortality among patients infected with SARS-CoV-2 varied based on geographical location.

Background and Aims: Single-operator cholangioscopy-assisted electrohydraulic lithotripsy (SOC-EHL) is effective and safe in difficult choledocholithiasis. The optimal timing of SOC-EHL use, however, in refractory stones has not been elucidated. The following aims to determine the most cost-effective timing of SOC-EHL introduction in the management of choledocholithiasis. Methods: A cost-effectiveness model was developed assessing three strategies with a progressively delayed introduction of SOC-EHL. Probability estimates of patient pathways were obtained from a systematic review. The unit of effectiveness is complete ductal clearance without need for surgery. Cost is expressed in 2018 US dollars and stem from outpatient US databases. Results: The three strategies achieved comparable ductal clearance rates ranging from 97.3% to 99.7%. The least expensive strategy is to perform SOC-EHL during the first endoscopic retrograde cholangiography pancreatography (ERCP) (SOC-1: 18,506$). The strategy of postponing the use of SOC-EHL to the third ERCP (SOC-3) is more expensive (US$18,895) but is 2% more effective. (0.9967). SOC-EHL during the second ERCP in the model (SOC-2) is the least cost-effective. Sensitivity analyses show altered conclusions according to the cost of SOC-EHL, effectiveness of conventional ERCP, and altered willingness-to-pay (WTP) thresholds with early SOC-1 being the most optimal approach below a WTP cut-off of US$20,295. Conclusions: Early utilization of SOC-EHL (SOC-1) in difficult choledocholithiasis may be the least costly strategy with an effectiveness approximating those achieved with a delayed approach where one or more conventional ERCP(s) are reattempted prior to SOC-EHL introduction.

Background Endoscopic procedures performed after-hours often require therapeutic interventions that are technically demanding for the endoscopist. The aim of this position paper is to provide guidance on the minimum standard of equipment that should be available on a mobile endoscopy cart for provision of a safe and effective after-hours emergency endoscopy service. The guidance is based on consensus among academic and community gastroenterologists in Canada. Methods A modified Delphi process was used to establish consensus among 9 participants. A list of statements was prepared by an expert panel of endoscopists. The statements were divided into three broad sections for what should be on an after-hours endoscopy cart including medications, nonendoscopic tools and therapeutic/diagnostic equipment. Consensus for being on the endoscopy cart was achieved when 75% or more of voting members indicated ‘agree’. Results For nonendoscopic tools, there was agreement for having sterile saline, sterile water, endoscope lubricant, various syringes, bite blocks (paediatric and adult size), a water pump with foot peddle, formalin jars for biopsy specimens, digital photo and printing capability and an overtube. For medications, there was agreement for having hyoscine butylbromide and epinephrine on the cart. For therapeutic/diagnostic tools, there was agreement for having biopsy forceps (standard and jumbo), polypectomy snares, sclerotherapy needles and agent (for a variceal bleed), band ligation kit, multipolar electrocautery probes, heater probe catheter, endoscopic clips, hemostatic powder and retrieval devices. Interpretation This position paper provides guidance on the minimum standard of items that should be on an after-hours endoscopy cart. Standardization of equipment may help improve safety and quality of after-hours endoscopic procedures.

Background and study aims Endoscopic ultrasound (EUS)-guided biliary drainage (BD) is increasingly used for distal malignant biliary obstruction, yet its safety and efficacy compared to endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) remain unclear. We performed a meta-analysis to improve our understanding of the role of EUS-BD in this patient population. Methods We searched Embase, MEDLINE, CENTRAL, and ISI Web of Knowledge through September 2018 for randomized controlled trials (RCTs) comparing EUS-BD to ERCP-BD or PTBD as treatment of distal malignant biliary obstruction. Risk ratios (RRs) with 95 % confidence intervals (CIs) were combined using random effects models. The primary outcome was risk of stent/catheter dysfunction requiring reintervention. Results Of six trials identified, three (n = 222) compared EUS-BD to ERCP-BD for first-line therapy; three others (n = 132) evaluated EUS-BD versus PTBD after failed ERCP-BD. EUS-BD was associated with a decreased risk of stent/catheter dysfunction overall (RR, 0.39; 95 %CI 0.27 – 0.57) and in planned subgroup analysis when compared to ERCP (RR, 0.41; 95 %CI 0.23 – 0.74) or PTBD (RR, 0.37, 95 %CI 0.22 – 0.61). Compared to ERCP, EUS was associated with a decreased risk of post-procedure pancreatitis (RR, 0.12; 95 %CI 0.01 – 0.97). No differences were noted in technical or clinical success. Conclusions In a meta-analysis of randomized trials comparing EUS-BD to conventional biliary drainage modalities, no difference in technical or clinical success was observed. Importantly, EUS-BD was associated with decreased risks of stent/catheter dysfunction when compared to both PTBD and ERCP, and decreased post-procedure pancreatitis when compared to ERCP, suggesting the potential role for EUS-BD as an alternative first-line therapy in distal malignant biliary obstruction.

Background The management of ampullary lesions has shifted from surgical approach to endoscopic resection. Previous reports were limited by small numbers of patients and short follow-up. The aim of this study is to describe short- and long-term outcomes in a large cohort of patients undergoing endoscopic ampullectomy. Methods Retrospective study of endoscopic ampullectomies performed at a tertiary center from January 1999 to October 2016. Information recorded includes patient demographics, clinical outcomes, lesion pathology, procedural events, adverse events and follow-up data. Results Overall, 103 patients underwent endoscopic resection of ampullary tumours (mean age 62.3 ± 14.3 years, 50.5% female, mean lesion size 20.9 mm; 94.9% adenomas, with a majority of lesions exhibiting low-grade dysplasia (72.7%). Complete endoscopic resection was achieved in 82.5% at initial procedure. Final complete endoscopic resection was achieved in all patients with benign pathology on follow-up procedures. Final pathology showed that 11% had previously undiagnosed invasive carcinoma. Delayed postprocedure bleeding occurred in 21.4%, all of which were managed successfully at endoscopy. Acute pancreatitis complicated 15.5% of procedures (mild in 93.8%). Perforation occurred in 5.8%, all treated conservatively except for one patient requiring surgery. Piecemeal resection was associated with significantly higher recurrence compared to en-bloc resection (54.3% versus 26.2%, respectively, P = 0.012). All recurrences were treated endoscopically. Conclusion Endoscopic ampullectomy appears both safe and effective in managing patients with ampullary tumours in experienced hands. Most adverse events can be managed conservatively. Many patients develop recurrence during long-term follow-up but can be managed endoscopically. Recurrence rates may be reduced by performing initial en-bloc resection.

BACKGROUND Restrictive red blood cell (RBC) transfusion reduces mortality and rebleeding after upper gastrointestinal bleeding (UGIB). However, there is no evidence to guide transfusion strategies in lower gastrointestinal bleeding (LGIB). AIM To assess the association between RBC transfusion strategies and outcomes in patients with LGIB METHODS: This was a post hoc analysis of the UK National Comparative Audit of LGIB and the Use of Blood. The relationships between liberal RBC transfusion and clinical outcomes of rebleeding, mortality and a composite outcome for safe discharge were examined. Transfusion strategy was dichotomised and defined as "liberal" when transfusion was administered for haemoglobin (Hb) ≥80 g/L (or ≥90 g/L in patients with acute coronary syndrome) or major haemorrhage, and "restrictive" otherwise. Multivariable logistic regression models were used to assess the independent association between liberal RBC transfusion and outcomes. RESULTS Of 2528 consecutive patients enrolled from 143 hospitals in the original study, 666 (26.3%) received RBC transfusion (mean age 73.3 ± 16 years, 49% female, initial mean haemoglobin 90 ± 24 g/L, 2.3% had haemodynamic instability). The rebleeding rate in transfused patients was 42.3%. After adjusting for potential confounders, there was no difference between liberal and restrictive RBC transfusion strategies for the odds of rebleeding (OR 0.89, 95% CI 0.6-1.22), in-hospital mortality (OR 0.54, 95% CI 0.3-1.1) or of achieving the composite outcome (OR 0.72, 95% CI 0.5-1.1). CONCLUSION Although these results could be due to residual confounding, they provide an important foundation for the design of randomised trials to evaluate transfusion strategies for LGIB.

Background & Aims Failed bowel preparation for colonoscopy occurs commonly, but the optimal regimen for the subsequent attempt is unknown. High-volume preparations often are used but are not well studied. The objective of this study was to compare the efficacy, tolerability, and safety of 2 regimens for use after failed bowel preparation. Methods A multicenter, endoscopist-blinded randomized controlled trial was conducted in patients who previously failed bowel preparation despite adequate compliance. Patients were randomized to 1 of 2 split polyethylene glycol (PEG) regimens, preceded by 15 mg bisacodyl: PEG 2 L the evening before and 2 L the day of colonoscopy (PEG 2+2L+bisacodyl), or 4 L and 2 L (PEG 4+2L+bisacodyl). All patients followed a low-fiber diet on both the third and second day before the procedure, followed by a clear fluid diet the day before and the morning of the colonoscopy. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale total score of 6 or higher, with all segment scores of 2 or higher. Secondary outcomes included adenoma detection rate, advanced adenoma detection rate, sessile serrated lesion detection, cecal intubation rate, tolerability, and adverse events. Results A total of 196 subjects were randomized at 4 academic centers in Canada (mean age, 60.7 y; SD, 11.4 y; 44.9% were women). There were no significant differences between the PEG 2+2L+bisacodyl and the PEG 4+2L+bisacodyl groups in achieving adequate bowel preparation (91.2% vs 87.6%; P = .44). There were no significant differences with regard to mean adenoma detection rate (37.4% vs 31.5%; P = .41), advanced adenoma detection rate (18.7% vs 11.2%; P = .16), sessile serrated lesion detection (8.8% vs 5.6%; P = .41), and cecal intubation rate (96.7% vs 92.1%; P = .19). The 2 regimens were similarly well tolerated, but PEG 2+2L+bisacodyl was associated with a higher willingness to repeat the bowel preparation (91.2% vs 66.2%; P Conclusions Split-dose 4 L-PEG with 15 mg bisacodyl, along with dietary restrictions, has similar efficacy as a higher-volume preparation, and should be considered for patients who previously failed bowel preparation ( ClinicalTrials.gov number, NCT02976805 ).

Background Acute gastrointestinal bleeding (GIB) remains a common cause of hospitalisation. However, interpretation and comparisons of published studies in GIB have been hampered by disparate study methodology. Aims To make recommendations about outcome measures to be used in future randomised controlled trials (RCTs) of patients with acute bleeding from any GI source (nonvariceal UGI, variceal, small bowel, or colon) and suggest new RCTs in acute GIB for future peer-reviewed funding. Methods As part of a National Institutes of Health conference entitled "Hemostatic Outcomes in Clinical Trials", a group of GIB experts performed targeted critical reviews of available evidence with the goal of proposing a bleeding outcome that could potentially be applied to different disciplines. In addition, the panel sought to develop a clinically meaningful primary endpoint specifically for acute GIB, potentially allowing a more contemporary regrouping of clinically relevant outcomes. Results The primary endpoint proposed was a composite outcome of further bleeding within 30 days after randomisation leading to red blood cell transfusion, urgent intervention (repeat endoscopy; interventional radiology or surgery), or death. Secondary outcomes may include the individual components of the primary outcome, length of hospitalisation, serious adverse events, and health care resource utilisation. Conclusion The proposed endpoint may help move the GIB field forward by focusing on the most clinically relevant outcomes for patients with acute GIB of all types and informing study design and importance of sample size determination for future RCTs in GIB.

Guidelines from national and international professional societies on upper gastrointestinal bleeding highlight the important clinical issues but do not always identify specific management strategies pertaining to individual patients. Optimal treatment should consider the personal needs of an individual patient and the pertinent resources and experience available at the point of care. This article integrates international guidelines and consensus into three stages of management: pre-endoscopic assessment and treatment, endoscopic evaluation and haemostasis and postendoscopic management. We emphasise the need for personalised management strategies based on patient characteristics, nature of bleeding lesions and the clinical setting including available resources.

Background and study aim Checklists prevent errors and have a positive impact on patient morbidity and mortality in surgical settings. Despite increasing use of checklists in gastrointestinal endoscopy units across many countries, a summary of cumulated experience is lacking. The aim of this study was to identify and evaluate the feasibility of successful checklist implementation in gastrointestinal endoscopy units and summarise the evidence of its impact on the commitment in safety culture. Methods A comprehensive literature search was performed identifying the use of a checklist or time-out in endoscopy units from 1978 to January 2020 using OVID MEDLINE, EMBASE, and ISI Web of Knowledge databases, with search terms related to checklist and endoscopy. We summarised overall adherence to checklists from included studies through a narrative synthesis, characterizing barriers and facilitators according to nurse and physician perspectives, while also summarizing safety endpoints. Results The seven studies selected from 673 screened citations were highly heterogeneous in terms of methodology, context, and outcomes. Across five of these, checklist adherence rates post-intervention varied for both nurses (84 % to 96 %) and physicians (66 % to 95 %). Various facilitators (education, continued reassessment) and barriers (lack of safety culture, checklist completion time) were identified. Most studies did not report associations between checklist implementation and clinical outcomes, except for better team communication. Conclusion Implementation of a gastrointestinal endoscopy checklist is feasible, with an understanding of relevant barriers and facilitators. Apart from a significant increase in the perception of team communication, evidence for a measurable impact attributable to gastrointestinal checklist implementation on endoscopic processes and safety outcomes is limited and warrants further study.

We performed systematic reviews addressing predefined clinical questions to develop recommendations with the GRADE approach regarding management of patients with overt upper gastrointestinal bleeding. We suggest risk assessment in the emergency department to identify very-low-risk patients (e.g., Glasgow-Blatchford score = 0-1) who may be discharged with outpatient follow-up. For patients hospitalized with upper gastrointestinal bleeding, we suggest red blood cell transfusion at a threshold of 7 g/dL. Erythromycin infusion is suggested before endoscopy, and endoscopy is suggested within 24 hours after presentation. Endoscopic therapy is recommended for ulcers with active spurting or oozing and for nonbleeding visible vessels. Endoscopic therapy with bipolar electrocoagulation, heater probe, and absolute ethanol injection is recommended, and low- to very-low-quality evidence also supports clips, argon plasma coagulation, and soft monopolar electrocoagulation; hemostatic powder spray TC-325 is suggested for actively bleeding ulcers and over-the-scope clips for recurrent ulcer bleeding after previous successful hemostasis. After endoscopic hemostasis, high-dose proton pump inhibitor therapy is recommended continuously or intermittently for 3 days, followed by twice-daily oral proton pump inhibitor for the first 2 weeks of therapy after endoscopy. Repeat endoscopy is suggested for recurrent bleeding, and if endoscopic therapy fails, transcatheter embolization is suggested.

Background & Aims Colonoscopy is required following a positive fecal screening test for colorectal cancer (CRC). It remains unclear to what extent time to colonoscopy is associated with CRC-related outcomes. We performed a systematic review to elucidate this relationship. Methods An electronic search was performed through April 2020 for studies reporting associations between time from positive fecal testing to colonoscopy and outcomes including CRC incidence (primary outcome), CRC stage at diagnosis, and/or CRC-specific mortality. Our primary objective was to quantify these relationships following positive fecal immunochemical testing (FIT). Two authors independently performed screening, abstraction, and risk of bias assessments. Results From 1,612 initial studies, 8 were included in the systematic review, with 5 reporting outcomes for FIT. Although meta-analysis was not possible, consistent trends between longer time delays and worse outcomes were apparent in all studies. Colonoscopy performed beyond 9 months from positive FIT compared to within 1 month was significantly associated with a higher incidence of CRC, with adjusted odds ratios (AORs) of 1.75 and 1.48 in the two largest studies. These studies also reported significant associations between colonoscopy performed beyond 9 months and higher incidence of advanced stage CRC (stage III or IV) at diagnosis, with AORs of 2.79 and 1.55, respectively. Conclusions Colonoscopy for positive FIT should not be delayed beyond 9 months. Given the additional time required for urgent referrals and surgical planning for CRC, colonoscopy should ideally be performed well in advance of 9 months following a positive FIT.

The current pandemic of coronavirus disease 2019 (COVID-19) which was first detected in Wuhan, China in December 2019 is caused by the novel coronavirus named severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The virus has quickly spread to a large number of countries leading to a great number of deaths. Unfortunately, till today there is no specific treatment or vaccination for SARS-CoV-2. Most of the suggested treatment medications are based on in vitro laboratory investigations, experimental animal models, or previous clinical experience in treating similar viruses such as SARS-CoV-1 or other retroviral infections. The running of any clinical trial during a pandemic is affected at multiple levels. Reasons for this include patient hesitancy or inability to continue investigative treatments due to self-isolation/quarantine, or limited access to public places (including hospitals). Additional barriers relate to health care professionals being committed to other critical tasks or quarantining themselves due to contact with COVID-19 positive patients. The best research approaches are those that adapt to such external unplanned obstacles. Ongoing clinical trials before COVID-19 pandemic have the potential for identifying important therapies in the long-term if they can be completed as planned. However, these clinical trials may require modifications due a pandemic such as this one to ensure the rights, safety, and wellbeing of participants as well as medical staff involved in the conduction of clinical trials. Clinical trials initiated during the pandemic must be time-efficient and flexible due to high contagiousness of severe acute respiratory syndrome coronavirus 2, the significant number of reported deaths, and time constraints needed to perform high quality clinical trials, enrolling adequate sample sizes. Collaboration between different countries as well as implementation of innovative clinical trial designs are essential to successfully complete such initiatives during the current pandemic. Studies looking at the long term sequalae of COVID-19 are also of importance as recent publications describe multi-organ involvement. Long term follow-up of COVID-19 survivors is thus also important to identify possible physical and mental health sequellae.

Background The optimal timing of colonoscopy in acute lower gastrointestinal bleeding (LGIB) remains controversial. Aim To characterise the utility of early colonoscopy (within 24 hours) in managing acute LGIB. Methods A systematic literature search to October 2019 identified fully published articles and abstracts of randomised controlled trials (RCTs) and observational studies with control groups assessing early colonoscopy in acute LGIB. The primary outcome was rebleeding. Secondary outcomes included mortality, surgery, length of stay (LOS), definite cause of bleeding and adverse events. Odds ratios (ORs) and mean differences (MD) were calculated. Results Of 1116 citations, 4 RCTs (466 patients) and 13 observational studies with elective colonoscopy (>24 hours) as control group (1 061 281 patients) were included. No differences in rebleeding were noted between early and elective colonoscopy groups among RCTs alone (OR = 1.70; 0.79; 3.64), or observational studies alone (OR = 1.20; 0.69; 2.09). No other significant between-group differences in outcomes were found when restricting the analysis to RCTs. Among observational studies only, early colonoscopy was associated with lower rates of all-cause mortality (OR = 0.86; 0.75; 0.98), surgery (OR = 0.52; 0.42; 0.64), blood transfusion (OR = 0.81; 0.75; 0.87), units of blood transfusion (MD = -4.30; -6.24; -2.36) and shorter LOS (MD = -1.70; -1.70; -1.70 days). Conclusion In contradistinction to observational studies, data from RCTs do not support a role for early colonoscopy in the routine management of acute LGIB with regards to the most important clinical outcomes. Further research is needed to better identify patients with high-risk LGIB who may benefit from early colonoscopy.

Background and study aims: In recent years, cold snare polypectomy (CSP) has been recommended as the preferred approach for removal of small and diminutive colorectal polyps. We conducted an intern...

Background Single-operator cholangioscopy assisted electrohydraulic lithotripsy is the standard of care for difficult common bile duct (CBD) stones with failed clearance using standard ERCP. This technology is expensive and optimal timing of its use in terms of cost-effectiveness in the management algorithm of patients with difficult CBD stones remains unclear Aims To determine the cost-effective timing of SOC-EHL utilization in the management of difficult CBD stones Methods A decision model was developed assessing 4 strategies and progressively delayed introduction of SOC-EHL in relation to ERCP over 6-months. Difficult stones were defined as having failed CBD clearance via standard ERCP. Probability estimates for each health state were obtained from a literature systematic review. For each strategy, outpatients undergoing ERCP underwent different timings of SOC-EHL introduction from the first to the fourth ERCP and were followed for subsequent need for re-intervention, adverse events, need for surgery, and/or successful endoscopic CBD clearance. The unit of effectiveness was complete CBD clearance without need for surgery. Deterministic sensitivity analyses were performed varying all 50 model variables across ranges spanning 30% of their respective values. Costs are in 2018US$ based on US data. Results Performing SOC-EHL immediately during the first ERCP is the least expensive approach when compared to delaying SOC-EHL. This strategy costs $15,528 on average per patient with CBD clearance avoiding surgery and can save between $260 to $720 compared to the 3 other strategies, which introduce SOC-EHL during the second to the fourth ERCP. Effectiveness is clinically comparable between the four strategies ranging from 97–99%. Deterministic sensitivity analysis shows changes in the results when the ERCP complication rate (baseline probability of 6%) decreases to 4.5%, when the SOC-EHL (baseline costs of $2,450) costs more than $2,670, or when the ERCP facility fees (baseline costs of $4,292) are less than $3,425. In all 3 scenarios, delaying the first SOC-EHL use to the fourth procedural attempt becomes the dominant strategy. Variations of the other 47 variables did not alter results. Conclusions Although SOC-EHL is expensive, this analysis demonstrates that among patients who have failed a prior attempt at stone extraction, utilization of SOC-EHL at the next (first subsequent) ERCP is less costly when compared to its delayed introduction. However, postponing the use of SOC-EHL to the fourth ERCP could be identified as the most cost-effective strategy when facility fees or ERCP complications rates are below certain thresholds, or when the costs of SOC-EHL extend beyond a defined threshold. Funding Agencies None

Background Endoscopic ultrasound-guided biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP) in malignant distal biliary obstruction (MDBO). Recent small randomized controlled trials comparing EUS-BD with ERCP suggest that EUS-BD achieves a similar technical success rate and safety profile while potentially being associated with lower rates of stent dysfunction However, its application in clinical practice has been impeded by various undefined barriers. Aims To evaluate the current practice of EUS-BD and the determinants for its clinical implementation in MDBO. Methods An online survey was generated using Google Forms. Five endoscopy societies have distributed the survey as of October 10th, 2019. Survey questions measured participant characteristics, EUS-BD in different clinical scenarios, and potential barriers to implementation. Descriptive statistics were calculated using frequencies, chi-square statistics were used for inferential analysis, and a standard step-wise multivariable analysis was performed to identify independent variables for and against the use of EUS-BD. Results To date, 102 physicians have participated in the survey (response rate 7.97%). The majority of participants are from North America (39.2%), Asia (31.4%), and Europe (19.6%). Most participants are gastroenterologists with formal therapeutic endoscopy training (66.7%), though only 28.4% have received EUS-BD training. In unresectable cancer, 85.1% of respondents favoured EUS-BD over percutaneous biliary drainage following ERCP failure (p Conclusions In this international survey, it appears that EUS-BD is gaining traction, especially in the setting of unresectable disease following ERCP failure. However, barriers to implementation include the lack of high-quality data, fear for adverse events, limited experts in the field, and inadequate access to EUS technology. This suggest the need for high-quality clinical trials, increased endoscopist training in this field, and further technology development in EUS-BD in order to increase its uptake in clinical practice. Funding Agencies None

Background Adequate bowel cleansing before colonoscopy is, in theory, a simple concept but the high rate of inadequate or incomplete bowel cleanliness and its consequences have been the subject of many studies, guidelines, and meta- analyses. The complexity resides in all the pre-endoscopic factors surrounding preparation intake that may? influence quality of the bowel preparation. Aims To identify preendoscopic variables associated with inadequate bowel preparation Methods In this randomized trial conducted in adult outpatients in 10 Canadian hospitals, all early morning (AM) colonoscopies were scheduled between 7h30AM and 10h30AM and patients were randomized to PEG low volume or high- volume split-dose or high- volume day before. Later colonoscopies (PM) were scheduled between 10h30AM and 16h30PM and patients were randomized to PEG low-volume or high- volume split-dose or low- volume same day. A secondary random allocation assigned patients to a clear fluid or low residue diet. Inadequate bowel preparation was identified on the Boston Bowel Preparation Scale with a total score Results Over 29 months, 1726 patients were stratified in the AM group and 1750 patients in the PM group. 16.9% had inadequate bowel preparation in the AM group and 9.8% in the PM group. Pre-endoscopic variables associated with an inadequate bowel cleanliness in AM colonoscopy were a non screening indication (OR 1.36, 95%CI 1.04–1.78), a Charlson score>0 (OR 1.36, 95% 1.03–1.80) and a low residue diet (OR 1.53, 95%CI 1.17–2.01). Amongst PM colonoscopies, variables associated with an inadequate bowel cleanliness were increased age (OR 1.03, 95% 1.01–1.04), a non screening indication (OR 1.90 95%CI 1.35–2.70); a Charlson score>0 (OR 1.63, 95%CI 1.15–2.32), and a low residue diet (OR 1.41, 95%CI 1.01; 1.98). Conclusions In this large randomized trial, amongst patients undergoing an AM colonoscopy, pre- endoscopic factors associated with an inadequate bowel preparation were a non screening indication, comorbidities and a low residue diet. Amongst PM colonoscopy patients, in addition to these variables, an increased age was also associated with an inadequate bowel preparation. Funding Agencies received arm-length funding from Pendopharm Inc.

Background & Aims Primary sclerosing cholangitis (PSC) has a variable, often progressive, course. Magnetic resonance cholangiography (MRC) is used in the diagnosis of PSC. Magnetic resonance risk scoring systems, called Anali without and with gadolinium, are used to predict disease progression, determined by radiologic factors. We aimed to assess the prognostic value of Anali scores in patients with PSC and validate our findings in a separate cohort. Methods We performed a retrospective study of patients with large-duct PSC (internal cohort, 119 patients in France; external cohort, 119 patients in Canada, Italy, and the United Kingdom). All the first-available MRC results were reviewed by 2 radiologists and the Anali scores were calculated as follows: Anali without gadolinium = (1× dilatation of intrahepatic bile ducts) + (2× dysmorphy) + (1× portal hypertension); Anali with gadolinium = (1× dysmorphy) + (1× parenchymal enhancement heterogeneity). The primary end point was survival without liver transplantation or cirrhosis decompensation. The prognostic value of Anali scores was assessed by Cox regression modeling. Results During a total of 549 patient-years for the internal cohort and 497 patient-years for the external cohort, we recorded 2 and 8 liver transplantations, 4 and 3 liver-related deaths, and 26 and 25 cirrhosis decompensations, respectively. In the univariate analysis, factors associated with survival without liver transplantation or cirrhosis decompensation in the internal cohort were as follows: serum levels of bilirubin, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transferase, alkaline phosphatase, albumin, and Anali scores. Anali scores without and with gadolinium identified patients' survival without liver transplantation or cirrhosis decompensation with a c-statistic of 0.89 (95% CI, 0.84–0.95) and 0.75 (95% CI, 0.64–0.87), respectively. Independent prognostic factors identified by multivariate analysis were Anali scores and bilirubinemia. The prognostic value of Anali scores was confirmed in the external cohort. Conclusions In internal and external cohorts, we found that Anali scores, determined from MRC, were associated with outcomes of patients with PSC. These scores might be used as prognostic factors.

Background and study aims Endoscopic ultrasound-guided drainage is an effective and accepted primary modality for management of pancreatic pseudocyst (PP). A lumen-apposing metal stent (LAMS) has recently been developed specifically for drainage of pancreatic fluid collections which may be superior to using traditional plastic stents (PS) but is more expensive. Because use of a stent involves a risk of unplanned endoscopy, percutaneous drainage (PCD) and surgery, their costs should also be included in the comparison and a cost-effectiveness analysis of LAMS and PS should therefore be performed Patients and methods A decision tree was developed assessing both endoscopic drainage strategies for patients with PP: LAMS and PS over a 6-month time horizon. For each strategy, inpatients received a stent and were followed for subsequent need for direct further interventions or adverse events leading to unplanned endoscopy, PCD, surgery, or successful endoscopic drainage using probabilities obtained from the literature. The unit of effectiveness was successful endoscopic drainage without need for PCD or surgery. Sensitivity analyses were performed. Results Success rates were 93.9 % for LAMS and 96.96 % for PS. Respective costs per successful drainage were US $ 18,129 (LAMS) and US $ 10,403 (PS). The LAMS strategy was thus characterized as dominated by the PS approach because it was costlier and less effective than PS. Both deterministic and probabilistic sensitivity analyses confirmed the robustness of these findings. Conclusion Use of LAMS is not less effective and more costly than PS in management of patients with PP. As such, PS should be preferred over LAMS as initial management of these patients.

Background and Aims Endoscopic hemostatic techniques remain poorly effective for GI tumor bleeding. We assessed Tc-325 (Hemospray, Cook Medical, Bloomington, Ind, USA) for this indication and determined possible predictors of decreased recurrent bleeding and improved 6-month survival in affected patients. Methods This retrospective study identified 99 patients with active malignant GI bleeding (primary or metastatic) treated with Tc-325. Eleven patients were excluded because of incomplete data. Data on patient characteristics and possible predictive factors of early (72-hour) and delayed (7-, 14-, and 30-day) recurrent bleeding, as well as 6-month survival, were collected. Results Overall, 70.5% were male (age, 65 ± 14 years). Half had a high Eastern Cooperative Oncology Group (ECOG) score (3 or 4). An upper GI cancer was found in 56.8%, and 72.7% cancers were stage 4. Of those affected, 51.6% received at least 1 non-endoscopic additional definitive hemostatic treatment after Tc-325. Immediate hemostasis with Tc-325 was 97.7%, with recurrent bleeding noted in 15% (early) and 17% (delayed). Six-month survival was 53.4%. On multivariable analysis, no predictive factor for recurrent bleeding was identified, whereas ECOG score 0 to 2 ( P = .001; hazard ratio [HR], 0.14; 95% confidence interval [CI], 0.04-0.47), cancer stage 1 to 3 ( P = .04; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostatic treatment alone or in any combination with surgery, chemotherapy, radiotherapy, or radiologic embolization ( P = .002; HR, 0.24; 95% CI, 0.09-0.59) were significant prognosticators of 6-month survival after adjusting for comorbidity, type of cancer bleeding, and presence of a coagulopathy. Conclusion Before definitive therapy can be offered, Tc-325 provides effective initial hemostasis of tumoral GI bleeding. Good performance status, non-end-stage cancer, and receiving definite hemostatic treatment are independent predictors of 6-month survival. (Clinical trial registration number: NCT03066700.)

Background Despite overall evidence in the literature favoring rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), its role in preventing potentially fatal complications is not well explored. Method A comprehensive electronic literature search was done to select randomized controlled trials (RCTs) comparing rectal indomethacin and placebo in preventing PEP. Methodological quality was assessed using the Cochrane risk of bias tool. Statistical heterogeneity was characterized. Random effect model meta-analysis was used. Several subgroup, sensitivity and aggregate subgroup data analyses were completed based on specific risk factors or patient characteristics to identify patient populations who may benefit most from rectal indomethacin. Results A total of eight out of 336 trials published between 2007 and 2016 (n=3324) were included. Analysis showed administering rectal indomethacin before rather than during or after ERCP significantly reduced PEP rates (odds ratio (OR): 0.56 [0.40–079]). Rectal indomethacin also significantly decreased the rate of moderate to severe PEP and death amongst all patients (OR: 0.53 [0.31–0.89] and 0.10 [0.02–0.65], respectively). Rectal indomethacin significantly prevented PEP in patients with sphincter of Oddi dysfunction (SOD) (OR: 0.49 [0.30–0.78]) and those undergoing biliary sphincterotomy (OR: 0.63 [0.42–0.95]), but not in those undergoing precut or pancreatic sphincterotomy or prophylactic pancreatic stent placement. Sensitivity analysis showed that the effect remained significant after two studies with high risk of bias were excluded. Conclusion Rectal indomethacin significantly decreases the occurrence of moderate to severe PEP and death in all patients, only if given before the procedure.

Objectives Balloon-assisted enteroscopy (BAE) is increasingly used for the evaluation of small bowel disorders. We quantified local diagnostic and therapeutic yields of BAE in patients with suspected small bowel diseases. Methods Adult patients undergoing BAE between January 2010 and July 2015 at McGill University Health Centre were included. Procedures were identified using a prospectively maintained database. Patients were excluded if procedure report was unavailable. Electronic medical records were reviewed. Analyses were restricted to patients who did not have a previous BAE. Results BAE was performed in 453 patients, including 421 anterograde cases. Patients had a mean age of 61.0 ± 17.5 years. Most common indications for referral were obscure gastrointestinal bleeding (OGIB) (n=207, 45.7%), abnormal imaging (n=88, 19.4%), suspected small bowel neoplasia (SBN) (n=39, 8.6%) and Crohn’s disease (CD) (n=31, 6.8%). A diagnosis was established in 216 procedures (47.7%). A pre-endoscopic indication of CD (odds ratio [OR]: 3.78; 95% Confidence Interval [CI], 1.60–8.90), OGIB (OR: 3.69, 95% CI, 2.03–6.71), suspected SBN (OR: 2.45; 95% CI, 1.06–5.65) and previous VCE (OR: 9.33; 95% CI, 3.24–26.90) were associated with abnormal findings. A therapeutic procedure was performed in 126 cases (28.3%). OGIB (OR: 7.00; 95% CI, 3.83–12.81), previous video capsule endoscopy (VCE) (OR: 7.86; 95% CI, 2.93–21.04) and suspected SBN (OR: 6.30; 95% CI, 2.58–21.04) were associated with performance of a therapeutic intervention. Complication rate was 1.6%, with bleeding in seven cases and one perforation. Conclusions In carefully selected patients, such as those with OGIB, Crohn’s disease and previous VCE, BAE was a safe procedure that led to the identification of abnormal findings and therapeutic interventions.

AIM To summarize and compare worldwide colorectal cancer (CRC) screening recommendations in order to identify similarities and disparities. METHODS A systematic literature search was performed using MEDLINE, EMBASE, Scopus, CENTRAL and ISI Web of knowledge identifying all average-risk CRC screening guideline publications within the last ten years and/or position statements published in the last 2 years. In addition, a hand-search of the webpages of National Gastroenterology Society websites, the National Guideline Clearinghouse, the BMJ Clinical Evidence website, Google and Google Scholar was performed. RESULTS Fifteen guidelines were identified. Six guidelines were published in North America, four in Europe, four in Asia and one from the World Gastroenterology Organization. The majority of guidelines recommend screening average-risk individuals between ages 50 and 75 using colonoscopy (every 10 years), or flexible sigmoidoscopy (FS, every 5 years) or fecal occult blood test (FOBT, mainly the Fecal Immunochemical Test, annually or biennially). Disparities throughout the different guidelines are found relating to the use of colonoscopy, rank order between test, screening intervals and optimal age ranges for screening. CONCLUSION Average risk individuals between 50 and 75 years should undergo CRC screening. Recommendations for optimal surveillance intervals, preferred tests/test cascade as well as the optimal timing when to start and stop screening differ regionally and should be considered for clinical decision making. Furthermore, local resource availability and patient preferences are important to increase CRC screening uptake, as any screening is better than none.

Aims Failed bowel preparation is common during colonoscopy, yet the optimal purgative regimen to use for the next attempt is unknown. The objective of this study was to compare the efficacy, tolerability, and safety of two regimens at supratherapeutic doses for use after failed bowel preparation. Methods A multi-centre phase III endoscopist blinded randomized controlled trial (NCT02976805) was conducted in patients who failed bowel preparation, using the US Multi-Society Task Force (USMSTF) definition of inability to exclude polyps >5 mm in size and requiring a shortened interval to next colonoscopy. Regimen A consisted of 15 mg of bisacodyl and 2 + 2 L of split dose polyethylene glycol electrolyte solution (PEG) and Regimen B consisted of 15 mg of bisacodyl and 4 + 2 L of split dose PEG. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score ≥ 6 with all segment scores ≥ 2. Secondary outcomes were adequate bowel preparation using the USMSTF definition, median BBPS, adenoma detection (ADR), advanced adenoma detection (aADR), sessile serrated polyp detection (SSPDR), and cecal intubation (CIR). Adverse events were assessed at the time of the colonoscopy and 14 days later. Results Between February 2017 and December 2019, 250 subjects were screened at four academic centres in Canada, of which 195 were randomized: 96 to Regimen A and 99 to Regimen B. The mean (SD) age was 60.6 (11.4) years, 87 (45.1%) were female, and the median (IQR) total BBPS score at previous failed colonoscopy was 3 (1,4). Regimen B was not superior to Regimen A in achieving adequate bowel preparation using the BBPS definition (87.6% vs. 91.1%, p=0.45) or the USMSTF definition (85.4% vs 91.1%, p=0.24), nor was it superior with respect to the median BBPS score (7 vs 7, p=0.50), mean ADR (31.5% vs 37.8%, p=0.37), aADR (11.2% vs 18.9%, p=0.15), SSPDR (5.6% vs 8.9%, p=0.40) or CIR (92.1% vs 96.7%, p=0.19). Regimen A had a higher adherence rate (88.2% vs. 74.7%, p=0.02) and greater willingness to undergo the bowel preparation again (91.2% vs. 66.2%, p Conclusions Split dose 4L PEG with 15mg of bisacodyl is highly efficacious, well tolerated, and can be used for patients who previously failed first line bowel preparations. The additional 2L of PEG in Regimen B did not improve bowel preparation and was not as well tolerated. Funding Agencies AMOSO Opportunities Grant, Pharmascence Inc.

Background and study aim Few scales assessing bowel preparation quality have been validated, and direct between-scale comparisons remain scarce. The aim of the study was to compare inter- and intra-rater reliability, predictive abilities for clinical outcomes, and ease of use for each scale. Methods Colonoscopy video recordings highlighting five colonic segments after washing were viewed independently by three physicians, and cleanliness was evaluated using the Boston Bowel Preparation Scale (BBPS), the Chicago Bowel Preparation Scale (CBPS), and the Harefield Cleansing Scale (HCS) in randomized order. Kappa or intraclass correlations quantified intra- and inter-rater reliability. Ease of use was evaluated (1 – 10 scale, 1 = easy), as were associations between scores, adenoma detection, and adequacy of preparation to exclude lesions ≥ 5 mm. Results Among 83 colonoscopy videos, indications included screening or surveillance in 72.3 %. Mean (± SD) scores of the respective three raters were 5.17 ± 1.57, 6.49 ± 1.48, and 5.12 ± 1.21 for BBPS, and 23.73 ± 6.01, 28.39 ± 5.47, and 24.75 ± 5.83 for CBPS, while successful HCS scores (grade A or B) were given for 76 %, 89 %, and 63 % of examinations. Intra-rater reliability ranges were 0.88 – 1.00, 0.83 – 1.00, and 0.62 – 1.00 for BBPS, CBPS, and HCS, respectively. Similarly, inter-rater reliability ranges were 0.50 – 0.79, 0.64 – 0.83, and 0.28 – 0.52, respectively. Sources of disagreement included varying rater strictness, which was possibly most marked for preparations rated as intermediate. Overall, associations between preparation scores and adenoma detection lacked statistical significance. Conclusion The BBPS and CBPS showed the best inter- and intra-rater reliability, and the BBPS was considered the easiest to use. Further studies are needed to determine an optimal adequacy threshold for these scales, with the goal of predicting clinical outcomes and determining the appropriate interval to the next colonoscopy.