Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees.

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).

Creation of simulated papillae for endoscopic sphincterotomy and papillectomy training by using in vivo and ex vivo pig model (with videos).

BACKGROUND: There are few in vivo and ex vivo models for training in endoscopic sphincterotomy (ES) and endoscopic papillectomy (EP). OBJECTIVE: We describe in vivo and ex vivo training pig models that use a simulated papilla for hands-on teaching of ES and EP. DESIGN: Animal experiment. SETTING: A referral center. MATERIALS AND INTERVENTIONS: Hyaluronate solution (0.4%) was injected submucosally using a 25-gauge sclerotherapy needle to create a submucosal bleb by using porcine in vivo stomach, ex vivo stomach, and ex vivo rectum. ES and EP were then performed by using a pull-type sphincterotome and snare, respectively. MAIN OUTCOME MEASUREMENT: The feasibility of creating a simulated papilla for ES and EP procedures was tested by experienced and nonexperienced ERCP endoscopists. RESULTS: Creation of a hemispheroidal bulge was successful in 13 of 17 (76%) areas within an in vivo stomach, 13 of 16 (81%) areas of an ex vivo stomach, and 16 of 16 (100%) areas in an ex vivo rectum. In the in vivo stomach model, ES was successfully and realistically performed on the anterior wall of the stomach rather than in other walls. In the ex vivo stomach model, endoscopists experienced in ERCP and trainees performed ES without difficulty, whereas it was difficult or impossible for nonexperienced trainees to perform ES. In the ex vivo rectum model, all 3 endoscopists were able to complete not only ES but also EP. LIMITATIONS: Pilot study. CONCLUSIONS: Although further studies are necessary to evaluate the reproducibility and cost-effectiveness, this novel pig model appears useful for ES and EP training.

Quantitative assessment of technical proficiency in performing needle-knife precut papillotomy.

BACKGROUND: Although needle-knife precut papillotomy (NKPP) is considered a useful alternative for achieving selective biliary cannulation, controversy remains regarding the technical proficiency needed to perform the procedure and its safety. This study evaluated whether procedural experience with NKPP predicted either successful cannulation or the development of complications. METHODS: This study retrospectively investigated 104 patients, out of 589 consecutive patients with native papillary, who underwent NKPP performed by a single endoscopist between October 2002 and July 2006. To demonstrate changes in NKPP, the 104 patients were divided chronologically into two groups according to periods: period A (October 2002 to September 2004) and period B (October 2004 to July 2006). RESULTS: Of the 104 consecutive patients who underwent NKPP, 41 (41/267, 15%) were treated in period A and 63 (63/322, 20%) in period B. There was no significant difference in the overall success rate between periods A (90%) and B (98%) (p = 0.08). However, the initial success rate was higher in period B (95%) than in period A (80%) (p < 0.05). The complication rates were not significantly different between the two groups (10% vs 16%; p = 0.56). Although all complications involved pancreatitis, severe pancreatitis was not observed. CONCLUSION: Whereas the initial success rate for NKPP can increase with procedural experience, the complication rate does not seem to decrease. Furthermore, the need for NKPP does not appear to decrease with increasing endoscopic retrograde cholangiopancreatography (ERCP) experience.

How do we ensure that trainees learn to perform biliary sphincterotomy safely, appropriately, and effectively?

Sphincterotomy is a high-risk procedure with considerable complications. Trainees should learn and understand the basics of endoscopic retrograde cholangiopancreatography and sphincterotomy to ensure good clinical outcomes. Teaching of sphincterotomy usually involves supervised hands-on clinical practice with patients. Proper positioning of the endoscope allows for correct orientation with the papilla, and performing the cut along the "ideal" biliary axis optimizes results and reduces complications. Learning and practicing sphincterotomy can be supplemented by simulator models. The Neo-Papilla model uses a modified chicken heart attached to the porcine ex vivo model and allows for cutting of actual tissue. The mechanical simulator allows trainees to practice cutting an artificial papilla marked with the "perfect" axis to understand the proper sphincterotomy technique. Understanding the indications and contraindications helps with appropriate application of sphincterotomy. Objective criteria should be available for assessing performance. Improved technique and avoiding a deviated cut may improve overall results and prevent complications.

Safety and success of precut biliary sphincterotomy: Is it linked to experience or expertise?

AIM: To determine the rates of success and complications of precut biliary sphincterotomy (PBS) based on prior experience and to compare the complication rates between PBS and standard endoscopic sphincterotomy (ES). METHODS: A retrospective evaluation of prospectively collected non-randomized data at an academic tertiary referral center. The study included all patients in an eight-year period who underwent PBS and ES by a single endoscopist who had no formal training in PBS. The main outcome measures of the study were success and complications of PBS with a comparison to complications of ES. RESULTS: A total of 2939 endoscopic retrograde cholangiopancreatographies (ERCPs) were performed during the study period, including 818 (28%) ES and 150 (5%) PBS procedures. Selective biliary cannulation via PBS was successful at the first attempt in 75% of the patients. Cannulation was achieved in an additional 13% of the patients at a subsequent attempt (total 87%). Complication rate from PBS was 45% higher than ES, but did not differ significantly [7% (10/50) vs 5% (38/818), P = 0.29]. None of the complications from PBS was severe. A significant trend towards increasing success existed with regard to the endoscopistos first attempt at precut (P = 0.0393, Cochran-Armitage exact test for trend, Z = -1.7588). CONCLUSION: Despite the lack of specific training in this technique, PBS was performed with a high success rate and a complication rate similar to or less than reports from other experienced centers. These results suggest that endoscopic experience and perhaps innate endoscopic skill may play an important role in the outcome of this procedure.

The impact of a hands-on ERCP workshop on clinical practice.

BACKGROUND: Hands-on endoscopy workshops are increasingly common venues for procedure training. However, the effect of this type of training on the practices of participants is unknown. The goal of this study was to examine the changes in individual clinical practices subsequent to participation in an ERCP hands-on course. METHODS: Forty-eight practicing pancreatobiliary endoscopists participating in a 2-day hands-on advanced ERCP course were asked to complete a 24-item survey evaluating their endoscopic practices both before and 3 months after workshop participation. The surveys evaluated monthly volume and self-confidence in performing the following procedures: diagnostic ERCP, standard sphincterotomy, needle-knife pre-cut sphincterotomy, biliary stone extraction, mechanical lithotripsy, plastic stent placement, metal stent placement, and biliary brushing for cytologic specimens. RESULTS: Thirty-one of the 48 participants (65%) who completed both pre- and postcourse surveys form the study cohort. After the workshop, there was a significant increase in use of needle-knife pre-cut sphincterotomy in clinical practices. In addition, the post-workshop survey indicated a significant increase in confidence for procedures such standard sphincterotomy, needle-knife pre-cut sphincterotomy, stone extraction, mechanical lithotripsy, placement of metal stents, and cytology brushing. Confidence in basic diagnostic ERCP and plastic stent placement did not increase because of high initial confidence levels. CONCLUSIONS: Participation in a hands-on course appears to increase the confidence of endoscopists in the performance of more complex interventions. However, this was only associated with increased clinical application for one technique.