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Predictive models for hepatocellular carcinoma (HCC) have been limited by modest accuracy and lack of validation. Machine-learning algorithms offer a novel methodology, which may improve HCC risk prognostication among patients with cirrhosis. Our study's aim was to develop and compare predictive models for HCC development among cirrhotic patients, using conventional regression analysis and machine-learning algorithms. We enrolled 442 patients with Child A or B cirrhosis at the University of Michigan between January 2004 and September 2006 (UM cohort) and prospectively followed them until HCC development, liver transplantation, death, or study termination. Regression analysis and machine-learning algorithms were used to construct predictive models for HCC development, which were tested on an independent validation cohort from the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial. Both models were also compared with the previously published HALT-C model. Discrimination was assessed using receiver operating characteristic curve analysis, and diagnostic accuracy was assessed with net reclassification improvement and integrated discrimination improvement statistics. After a median follow-up of 3.5 years, 41 patients developed HCC. The UM regression model had a c-statistic of 0.61 (95% confidence interval (CI) 0.56-0.67), whereas the machine-learning algorithm had a c-statistic of 0.64 (95% CI 0.60-0.69) in the validation cohort. The HALT-C model had a c-statistic of 0.60 (95% CI 0.50-0.70) in the validation cohort and was outperformed by the machine-learning algorithm. The machine-learning algorithm had significantly better diagnostic accuracy as assessed by net reclassification improvement (P<0.001) and integrated discrimination improvement (P=0.04). Machine-learning algorithms improve the accuracy of risk stratifying patients with cirrhosis and can be used to accurately identify patients at high-risk for developing HCC.

A biliary stricture is an abnormal narrowing in the ductal drainage system of the liver that can result in clinically and physiologically relevant obstruction to the flow of bile. The most common and ominous etiology is malignancy, underscoring the importance of a high index of suspicion in the evaluation of this condition. The goals of care in patients with a biliary stricture are confirming or excluding malignancy (diagnosis) and reestablishing flow of bile to the duodenum (drainage); the approach to diagnosis and drainage varies according to anatomic location (extrahepatic vs perihilar). For extrahepatic strictures, endoscopic ultrasound-guided tissue acquisition is highly accurate and has become the diagnostic mainstay. In contrast, the diagnosis of perihilar strictures remains a challenge. Similarly, the drainage of extrahepatic strictures tends to be more straightforward and safer and less controversial than that of perihilar strictures. Recent evidence has provided some clarity in multiple important areas pertaining to biliary strictures, whereas several remaining controversies require additional research. The goal of this guideline is to provide practicing clinicians with the most evidence-based guidance on the approach to patients with extrahepatic and perihilar strictures, focusing on diagnosis and drainage.

After determining the preferred access point, a lumen-apposing metallic stent (LAMS) catheter is advanced using electrocautery into the fluid-filled remnant, and the prosthesis is deployed with the distal flange in the remnant and the proximal flange in the pouch or jejunum (Figure 1). Because a second procedure is generally necessary anyway, one strategy to minimize the consequences of LAMS dislodgment is to delay ERCP until maturation of the fistula tract (10). If there is any difficulty reaching the papilla during an elective case, we favor delaying ERCP until after fistula tract maturation. Because EDGE functionally reverses the gastric bypass, a primary concern is persistent fistula formation after stent removal, with its attendant weight regain and metabolic consequences. [...]existing evidence suggests that b-ERCP is only successful in ∼70% of cases vs in >95% of cases of g-ERCP or EDGE; however, its risk profile is more favorable (3,9,13,14). [...]b-ERCP seems like a reasonable place to start in an infirm patient who is unlikely to tolerate complications, especially when a complete sphincterotomy is not mandatory (e.g., extraction of a single small stone).

In this trial involving patients at increased risk for pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP), rectal indomethacin reduced the incidence of this condition, as compared with placebo (9% vs. 17%). Acute pancreatitis is the most common major complication of endoscopic retrograde cholangiopancreatography (ERCP), 1 accounting for substantial morbidity, occasional death, and estimated health care expenditures of approximately $150 million annually in the United States. 2 , 3 Given the magnitude of this problem, more than 35 pharmacologic agents have been studied for the prophylaxis of post-ERCP pancreatitis, and many prospective clinical trials addressing chemoprevention have been conducted. To date, however, no medication has proved to be consistently effective in preventing post-ERCP pancreatitis on the basis of data from high-quality clinical trials, and no pharmacologic prophylaxis for post-ERCP pancreatitis is in widespread clinical use. . . .

The benefit of indomethacin suppositories for prophylaxis against post-ERCP pancreatitis (PEP) in high-risk patients was established in a landmark trial published in 2012. The aims of this study were to measure the adoption of indomethacin prophylaxis in widespread clinical practice, evaluate concurrent trends in pancreatic duct (PD) stent utilization, and estimate the impact of these changes on PEP in a high-risk population. Data were extracted from a commercial database (Explorys, IBM Watson Health, Somers, NY) that aggregates electronic health records from 26 US healthcare systems from 2009 to 2018. Using Systematized Nomenclature of Medicine Clinical Terms, we identified a cohort of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) and were at high risk for PEP based on narrow criteria. PEP was defined as an emergency department or hospital admission 1-5 days after ERCP with an associated diagnosis of pancreatitis. Twenty six thousand eight hundred twenty ERCPs were performed on this high-risk cohort from 2009 to 2018. The overall PEP rate during the study period was 8.6%. There was no decrease in PEP rates from 2012 to 2018. Beginning in 2012, indomethacin usage increased linearly (P < 0.001), but remained below 50% in 2018. As indomethacin increased, utilization of PD stents declined abruptly from 2013 to 2014 (40.7%-8.5%) and trended to a nadir of 3.0%. Despite its low cost, widespread availability, and level I evidence of benefit in reducing the risk of PEP in high-risk patients, the adoption of rectal indomethacin during ERCP has been slow and the medication continues to be under-utilized. In parallel, the PD stent usage has declined dramatically. The lack of change in PEP rates during the study period could be attributable to the persistent low usage of rectal indomethacin or the decline in PD stent use. Further educational efforts and quality assurance measures are warranted to ensure that rectal indomethacin and PD stent placement are more appropriately used in clinical practice.

Randomized controlled trials (RCTs) have yielded varying estimates of the benefit of flexible sigmoidoscopy (FS) screening for colorectal cancer (CRC). Our objective was to more precisely estimate the effect of FS-based screening on the incidence and mortality of CRC by performing a meta-analysis of published RCTs. Medline and Embase databases were searched for eligible articles published between 1966 and 28 May 2012. After screening 3,319 citations and 29 potentially relevant articles, two reviewers identified five RCTs evaluating the effect of FS screening on the incidence and mortality of CRC. The reviewers independently extracted relevant data; discrepancies were resolved by consensus. The quality of included studies was assessed using criteria set out by the Evidence-Based Gastroenterology Steering Group. Random effects meta-analysis was performed. The five RCTs meeting eligibility criteria were determined to be of high methodologic quality and enrolled 416,159 total subjects. Four European studies compared FS to no screening and one study from the United States compared FS to usual care. By intention to treat analysis, FS-based screening was associated with an 18% relative risk reduction in the incidence of CRC (0.82, 95% CI 0.73-0.91, p<0.001, number needed to screen [NNS] to prevent one case of CRC = 361), a 33% reduction in the incidence of left-sided CRC (RR 0.67, 95% CI 0.59-0.76, p<0.001, NNS = 332), and a 28% reduction in the mortality of CRC (relative risk [RR] 0.72, 95% CI 0.65-0.80, p<0.001, NNS = 850). The efficacy estimate, the amount of benefit for those who actually adhered to the recommended treatment, suggested that FS screening reduced CRC incidence by 32% (p<0.001), and CRC-related mortality by 50% (p<0.001). Limitations of this meta-analysis include heterogeneity in the design of the included trials, absence of studies from Africa, Asia, or South America, and lack of studies comparing FS with colonoscopy or stool-based testing. This meta-analysis of randomized controlled trials demonstrates that FS-based screening significantly reduces the incidence and mortality of colorectal cancer in average-risk patients.

Cholecystectomy after endoscopic sphincterotomy (ES) is associated with improved outcomes compared to ES alone, however randomized trials have included mainly fit surgical candidates. Our objective was to assess the impact of cholecystectomy after ES among elderly patients, in whom the perceived risks of surgery may be increased and the prevailing bias may be to defer cholecystectomy. We performed adjusted analyses comparing clinical outcomes in patients ≥65 years of age who did and did not undergo follow-up cholecystectomy after endoscopic sphincterotomy for choledocholithiasis, ascending cholangitis, or gallstone pancreatitis. We also compared adverse events between the two groups. In the ES alone group, 39.3% of patients experienced a recurrent complication compared with 18.0% in the ES and cholecystectomy group. After adjusting for comorbidities using multivariable regression, cholecystectomy in addition to ES was associated with a reduced risk of recurrent choledocholithiasis (OR 0.38, 95%CI 0.34-0.42, P<0.001), ascending cholangitis (OR 0.28, 95%CI 0.23-0.34, P<0.001), and gallstone pancreatitis (OR 0.35, 95%CI 0.24-0.49, P<0.001) compared to ES alone. This benefit was preserved after propensity score adjustment, in patients ≥75 years of age, and in those with major comorbidities including cancer, heart failure, and liver disease. Serious post-operative complications such as myocardial infarction, pulmonary embolism, and pneumonia were not more common in the cholecystectomy group. Among older patients, including those with serious comorbidities, cholecystectomy after endoscopic sphincterotomy was associated with a significant and clinically important reduction in recurrent complications compared to sphincterotomy alone. This benefit did not appear to be outweighed by surgical complications, highlighting the importance of cholecystectomy, even in elderly patients whose lifespans may be limited by unrelated conditions.

Endoscopic necrosectomy has emerged as the preferred treatment modality for walled-off pancreatic necrosis. This study was designed to evaluate the safety and efficacy of direct endoscopic necrosectomy with and without hydrogen peroxide (H2O2) lavage. Retrospective chart reviews were performed for all patients undergoing endoscopic transmural management of walled-off pancreatic necrosis at 9 major medical centers from November 2011 to August 2018. Clinical success was defined as the resolution of the collection by imaging within 6 months, without requiring non-endoscopic procedures or surgery. Of 293 patients, 204 met the inclusion criteria. Technical and clinical success rates were 100% (204/204) and 81% (166/189), respectively. For patients, 122 (59.8%) patients had at least one H2O2 necrosectomy (H2O2 group) and 82 (40.2%) patients had standard endoscopic necrosectomy. Clinical success was higher in the H2O2 group: 106/113 (93.8%) vs 60/76 (78.9%), P = 0.002. On a multivariate analysis, the use of H2O2 was associated with higher clinical success rate (odds ratio 3.30, P = 0.033) and earlier resolution (odds ratio 2.27, P < 0.001). During a mean follow-up of 274 days, 27 complications occurred. Comparing procedures performed with and without H2O2 (n = 250 vs 183), there was no difference in post-procedure bleeding (7 vs 9, P = 0.25), perforation (2 vs 3, P = 0.66), infection (1 vs 2, P = 0.58), or overall complication rate (n = 13 [5.2%] vs 14 [7.7%], P = 0.30). H2O2-assisted endoscopic necrosectomy had a higher clinical success rate and a shorter time to resolution with equivalent complication rates relative to standard necrosectomy.See the visual abstract at http://links.lww.com/AJG/B714.(Equation is included in full-text article.).

BackgroundComplications of endoscopic mucosal resection (EMR) of large colorectal polyps remain a concern.ObjectiveWe aimed to compare safety and efficacy of cold EMR (without electrocautery) to hot EMR (with electrocautery) of large colorectal polyps.DesignIn this multicentre randomised trial, patients with any large (≥20 mm) non-pedunculated colon polyp were assigned to cold or hot EMR (primary intervention), and to submucosal injection with a viscous or non-viscous solution (secondary intervention) following a 2×2 design. The primary outcome was the rate of severe adverse events (SAEs). The secondary outcome was polyp recurrence. In this study, we report results of the primary intervention.Results660 patients were randomised and analysed. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.10) (per protocol analysis 1.4 vs 5.0%, p=0.017) with fewer perforations following cold EMR (0%) compared with hot EMR (1.6%, p=0.028). Postprocedure bleeding did not differ (1.5% vs 2.2%, p=0.57). The effect of cold resection was independent of the type of submucosal injection solution, polyp size or antithrombotic medications. Recurrence was detected in 27.6% and 13.6% in the cold and hot EMR groups, respectively (p<0.001). Recurrence was not significantly different for 20–29 mm polyps (18.6% vs 13.4%, p=0.24) and for sessile serrated polyps (14.1% vs 8.5%, p=0.33).ConclusionUniversal application of cold EMR did not significantly lower SAEs (unless cold EMR could be completed) and doubled the recurrence rate compared with hot EMR.Trial registration detailsClinicalTrials.gov, number: NCT03865537.