Fast-tracking ERCP Learning: Does Training on a Mechanical Simulator Improve Trainee's Clinical Performance?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2023-10-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cholangiopancreatography, Endoscopic Retrograde Simulation Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Simulation group

Trainees will undergo routine hands-on clinical ERCP training. In addition, trainees from Simulation Group have coached simulation training, by participating in three two-days intensive courses during the first three months of training, with a monthly basis.

Group Type ACTIVE_COMPARATOR

Simulation training in Boškoski-Costamagna ERCP Trainer

Intervention Type OTHER

Coached simulation training in Boškoski-Costamagna ERCP Trainer, by participating in three intensive courses during the first three months of training, with a monthly basis

Control group

Trainees will undergo routine hands-on clinical ERCP training.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simulation training in Boškoski-Costamagna ERCP Trainer

Coached simulation training in Boškoski-Costamagna ERCP Trainer, by participating in three intensive courses during the first three months of training, with a monthly basis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes