Clinical trial NCT05533944: Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance?
Official title: Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance? A Randomized Trial To Evaluate Predictive Validity of Boškoski-Costamagna ERCP Trainer Simulator.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Simulation Training
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Amsterdam UMC, location VUmc
name: Universitaire Ziekenhuizen KU Leuven
name: Hospital Nord
name: Centre Hospitalier Universitaire de Nice
name: Erasmus Medical Center
name: Leiden University Medical Center
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Maastricht University Medical Center
First posted: 2022-09-09
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that novice trainees who are offered early simulation training in Boškoski-Costamagna ERCP Trainer in addition to routine hands-on training (intervention group) will demonstrate improved clinical outcomes compared to those undergoing routine hands-on ERCP training only (control group).

Detailed description: Background: Endoscopic retrograde cholangiopancreatography comprises one of the most challenging and complex endoscopic procedures with a steep learning curve. Consequently, adequate training is required to reach competence and perform these procedures safely and with efficacy. To avoid exposing patients to performer-related risk factors, as when trainees practice on real clinical situations, interest in simulator-based endoscopy education is growing. Nonetheless, the validity of simulators is mainly based on endoscopists' subjective opinions about their utility and the implementation of simulators in ERCP training programs is still limited. The Boškoski-Costamagna ERCP Trainer is one of the most appreciated simulation prototypes for ERCP training and has already been demonstrated to have a good face and construct validity. This study aims to evaluate the predictive validity of ERCP Trainer by analyzing the effect of simulation training on the basic ERCP skills of novice ERCP endoscopist trainees and assessing whether it offers an additional benefit to standard training in achieving clinical ERCP competence.

Methods: A prospective, multicenter trial, parallel-arm, randomized controlled trial will be conducted during 1 year. Sixteen "novice" Gastroenterology trainees in high-volume training centers will be randomized into two groups: Group A, intervention group (simulation group with ERCP Trainer) and Group B, control group (no simulation training). Both groups will undergo hands-on clinical ERCP training, supervised by local ERCP trainers, in each trainee's respective Institution. In addition, trainees from Group A will have coached simulation training, by participating in three intensive courses during the first three months of training, with a monthly basis, in Fondazione Policlinico Gemelli, Rome. During the clinical training period, clinical performance evaluation will be systematically evaluated in all ERCPs performed with any degree of trainee involvement. After each trainee completes a minimum of 60 ERCPs, data will be pooled and analyzed. Analysis of overall trainee's competence rates measured by the validated overall trainee's competence rate (TEESAT ERCP score, as primary outcome) and success rate of bile duct cannulation and adverse events rate (secondary outcomes) will be performed.

Eligibility criteria: Inclusion Criteria: Gastroenterology trainees from European high-volume training ERCP centers who have previously completed basic endoscopy training but are considered to be novice ERCP endoscopists.

Novice ERCP endoscopists are defined as trainees who have achieved competence in upper gastrointestinal endoscopy, have participated in fewer than 30 ERCPs (with no hands-on experience in ERCP) and are beginning training in a high-volume ERCP center.

Exclusion Criteria: Gastroenterologists with intermediate / advanced expertise in ERCP.

Primary outcomes:
measure: Overall trainee's competence rate
timeFrame: 6 months to 12 months
Secondary outcomes:
measure: Bile duct cannulation rate
timeFrame: 6 months to 12 months
measure: Adverse events rate
timeFrame: 6 months to 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Erasme University Hospital
name: Sara Teles de Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: