ASGE principles of endoscopic training.

This White Paper shares guidance on the important principles of training endoscopy teachers, the focus of an American Society for Gastrointestinal Endoscopy (ASGE)/World Endoscopy Organization Program for Endoscopic Teachers and Leaders of Endoscopic Training held at the ASGE Institute for Training and Technology. Key topics included the need for institutional support and continuous skills development, the importance of consensus and consistency in content and approach to teaching, the role of conscious competence and content breakdown into discreet steps in effective teaching, defining roles of supervisors versus instructors to ensure teaching consistency across instructors, identification of learning environment factors and barriers impacting effective teaching, and individualized training that incorporates effective feedback and adapts with learner proficiency. Incorporating simulators into endoscopy teaching, applying good endoscopy teaching principles outside the endoscopy room, key principles of hands-on training, and effective use of simulators and models in achieving specific learning objectives were demonstrated with rotations through hands-on simulator stations as part of the program. A discussion of competency-based assessment was followed by live sessions in which attendees applied endoscopy teaching principles covered in the program. Conclusions highlighted the need for the following: formal training of endoscopy teachers to a level of conscious competence, incorporation of formal training structures into existing training curricula, intentional teaching preparation, feedback to trainees and instructors alike aimed at improving performance, and competency-based trainee assessment. The article is intended to help motivate individuals who play a role in training other endoscopists to develop their teaching abilities, promote discussions about endoscopy training, and engage both endoscopy trainers and trainees in a highly rewarding learning process that is in the best interest of patients.

Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease.

BACKGROUND & AIMS: Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. METHODS: In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. RESULTS: Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. CONCLUSIONS: The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.

5F sphincterotomes and 4F sphincterotomes are equivalent for the selective cannulation of the common bile duct.

BACKGROUND: Cannulation of the common bile duct (CBD) is the first step in endoscopic retrograde cholangiopancreatography (ERCP). Cannulation difficulty is a known risk factor for post-ERCP complications and may be minimized by the use of a smaller caliber sphincterotome. OBJECTIVE: To compare the efficacy of CBD cannulation with a 4 F versus a 5 F sphincterotome. DESIGN: A randomized controlled trial, with concealed allocation and double-blinding. PATIENTS: Adult patients undergoing their first ERCP at a tertiary referral center. INTERVENTION: Patients were randomized to undergo CBD cannulation with either a 4 F or 5 F sphincterotome. MAIN OUTCOME MEASUREMENTS: Successful deep cannulation in <15 attempts was the primary outcome. Secondary outcomes included number of attempts/time to cannulation, incidence of complications within 24 hours, and overall cannulation success (including patients before and after crossover). Analysis was intention to treat and included standard descriptive and inferential methods. RESULTS: A total of 107 patients were randomized: 51 (4 F) versus 56 (5 F). The majority were female (71%) and white (92%). Baseline demographics, presenting symptoms, and laboratory values were similar between groups. Similar success in initial cannulation was observed: 84.3% (4 F) and 83.9% (5 F). No differences were noted in time to cannulation (5.12 min [SD, 4.8] for 4 F vs 4.46 min [SD, 4.13] for 5 F; p = NS), number of attempts to cannulation (6.2 [SD, 5.2] for 4 F vs 5.7 [SD, 4.9] for 5 F; p = NS), or complications. The overall cannulation success was 92.2% (4 F) and 92.9% (5 F). LIMITATIONS: Premature termination of the trial resulted in decreased power. CONCLUSIONS: There exists no significant difference in efficacy between 4 F and 5 F sphincterotomes. The choice of initial sphincterotome should be dictated by physician preference.

Endoscopic sphincterotomy by using pure-cut electrosurgical current and the risk of post-ERCP pancreatitis: a prospective randomized trial.

BACKGROUND: It has been suggested that the use of pure-cut electrosurgical current for endoscopic sphincterotomy may reduce the risk of post-ERCP pancreatitis. The aim of this study was to determine whether pure-cut current reduces the risk of pancreatitis compared with blend current. METHODS: Patients were randomly assigned to undergo sphincterotomy over a non-conductive guidewire with 30 W/sec pure-cut current or 30 W/sec blend-2 current by a blinded endoscopist. Serum amylase and lipase levels were determined 1 day before and within 24 hours after ERCP. Post-ERCP pancreatitis was the primary outcome of interest. Secondary outcomes were as follows: severity of immediate bleeding, as graded by a 3-point scale from 1 (no bleeding) to 3 (injection or balloon tamponade therapy required to stop bleeding) and evidence of delayed bleeding 24 hours after ERCP. Analyses were performed in intention-to-treat fashion. RESULTS: A total of 246 patients were randomized (116 pure-cut current, 130 blend current). There were no differences in baseline characteristics between the groups. The overall frequency of post-ERCP pancreatitis was 6.9%, with no significant difference in frequency between treatment arms (pure cut, 7.8% vs. blend, 6.1%; p = 0.62). The difference in rates of pancreatitis between the two groups was 1.7%: 95% CI[-4.8%, 8.2%]. Six patients (2.4%) had delayed bleeding after ERCP, of which two required transfusion. There was a significant increase in minor bleeding episodes (grade 2) in the pure-cut group (p < 0.0001). Delayed episodes of bleeding were equal (n = 3) in each arm. CONCLUSIONS: The type of current used when performing endoscopic sphincterotomy does not appear to alter the risk of post-ERCP pancreatitis. The selection of electrosurgical current for biliary endoscopic sphincterotomy should be based on endoscopist preference.