Endoscopy
DOI: 10.1055/a-2443-6582
Original article

Fast-tracking ERCP learning with the Boškoski–Costamagna Trainer: results of a multicenter randomized clinical trial

Sara Teles de Campos
1   Gastroenterology Department, Digestive Unit, Champalimaud Foundation, Lisbon, Portugal (Ringgold ID: RIN247170)
2   Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium (Ringgold ID: RIN26659)
3   Gastroenterology, Fondation Michel Cremer, Brussels, Belgium
,
Ivo Boškoski
4   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (Ringgold ID: RIN18654)
,
Theodor Voiosu
5   Gastroenterology, Carol Davila Faculty of Medicine, Spitalul Clinic Colentina, Bucharest, Romania (Ringgold ID: RIN433892)
,
Maurine Salmon
6   Data Center, Hopital Universitaire de Bruxelles, Brussels, Belgium (Ringgold ID: RIN680893)
,
4   Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy (Ringgold ID: RIN18654)
,
Alexandra Langers
7   Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, Netherlands (Ringgold ID: RIN4501)
,
7   Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, Netherlands (Ringgold ID: RIN4501)
,
8   Digestive Endoscopy, Centre Hospitalier Universitaire de Nice, Nice, France (Ringgold ID: RIN37045)
,
Cécile Gomercic
9   Department of Digestive Endoscopy, Centre Hospitalier Universitaire de Nice, Nice, France (Ringgold ID: RIN37045)
,
Arnaud Lemmers
2   Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium (Ringgold ID: RIN26659)
10   Gastroenterology, Hepatopancreatology and Digestive Oncology, Hôpital Erasme, Brussels, Belgium (Ringgold ID: RIN70496)
,
Paul Fockens
11   Gastroenterology and Hepatology, Amsterdam UMC Location AMC, Amsterdam, Netherlands (Ringgold ID: RIN26066)
,
11   Gastroenterology and Hepatology, Amsterdam UMC Location AMC, Amsterdam, Netherlands (Ringgold ID: RIN26066)
,
12   Gastroenterology, Hôpital Nord de Marseille, Marseille, France
,
12   Gastroenterology, Hôpital Nord de Marseille, Marseille, France
,
Wim Laleman
13   Gastroenterology and Hepatology, Section of Liver and Biliopancreatic Disorders and Liver Transplantation, University Hospitals Leuven, Leuven, Belgium (Ringgold ID: RIN60182)
14   Medizinische Klinik B, Universitätsklinikum Münster, Munster, Germany (Ringgold ID: RIN39069)
,
15   Endoscopy Unit, Department of Diagnostic and Therapeutic Services, Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo, Italy (Ringgold ID: RIN18326)
,
Jan Werner Poley
16   Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, Netherlands (Ringgold ID: RIN199236)
,
Rogier de Ridder
16   Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, Netherlands (Ringgold ID: RIN199236)
,
16   Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, Netherlands (Ringgold ID: RIN199236)
,
Marco J. Bruno
17   Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands (Ringgold ID: RIN6993)
,
Pieter J.F. de Jonge
17   Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands (Ringgold ID: RIN6993)
,
Jacques Devière
1   Gastroenterology Department, Digestive Unit, Champalimaud Foundation, Lisbon, Portugal (Ringgold ID: RIN247170)
2   Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium (Ringgold ID: RIN26659)
3   Gastroenterology, Fondation Michel Cremer, Brussels, Belgium
10   Gastroenterology, Hepatopancreatology and Digestive Oncology, Hôpital Erasme, Brussels, Belgium (Ringgold ID: RIN70496)
,
Marianna Arvanitakis
2   Gastroenterology, Université Libre de Bruxelles, Brussels, Belgium (Ringgold ID: RIN26659)
10   Gastroenterology, Hepatopancreatology and Digestive Oncology, Hôpital Erasme, Brussels, Belgium (Ringgold ID: RIN70496)
› Author Affiliations
Supported by: Sociedade Portuguesa De Endoscopia Digestiva Research Grant 2022

Clinical Trial: Registration number (trial ID): NCT05533944, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: prospective, multicenter, randomized trial


Abstract

Background Achieving competence in endoscopic retrograde cholangiopancreatography (ERCP) requires extensive training. Recognizing the potential of simulator-based education for safe and effective skill development, we aimed to assess whether initial training with the Boškoski–Costamagna ERCP Trainer (BCT) is beneficial compared with conventional training alone (i.e. predictive validity).

Methods A prospective multicenter randomized trial involving 16 novice ERCP trainees, randomly assigned to intervention or control groups, was performed. Both underwent hands-on training, with the intervention group receiving additional simulation training during the first 3 months. Each trainee was required to complete a minimum of 60 ERCPs in up to 1 year. The TEESAT score evaluated rates of global overall competence (primary outcome), biliary cannulation, and adverse events (AEs; secondary outcomes). Mixed-effect logistic regression models assessed differences in between-group ERCP procedure competence and success. Learning curves were generated cumulatively over the training period.

Results 1106 ERCPs (562 simulator group; 544 control group) were included. Although no statistically significant difference in global overall competence was observed between the groups, possibly owing to data heterogeneity, simulation training demonstrated higher success for native biliary cannulation (52% vs. 42%; P<0.001) and faster median (interquartile range) biliary cannulation times (3 [6] vs. 5 [8] minutes; P<0.001). The simulator group also showed faster improvements in overall performance, native biliary cannulation, and sphincterotomy. No statistical difference was found in overall AEs between the groups.

Conclusion Early simulation training with the BCT improved technical competence in native biliary cannulation and accelerated overall ERCP learning. This approach has the potential to enhance ERCP training programs.

Supplementary Material



Publication History

Received: 04 April 2024

Accepted after revision: 06 September 2024

Article published online:
14 November 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 
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