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

March 28, 2024 updated by: Erasme University Hospital

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Rome, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: 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
No Intervention: Control group
Trainees will undergo routine hands-on clinical ERCP training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall trainee's competence rate
Time Frame: 6 months to 12 months
The overall trainee's competence rates will be measured by TEESAT ERCP score, graded by supervisor trainer, and the difference between the simulation training group and control group will be compared.
6 months to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bile duct cannulation rate
Time Frame: 6 months to 12 months
Successful biliary cannulation will be specifically defined as deep placement of a guidewire into the common bile duct with contrast visualization.
6 months to 12 months
Adverse events rate
Time Frame: 6 months to 12 months
Complications include post-ERCP pancreatitis, perforation, bleeding, cholangitis, death and will be assessed up to 72 hours after the procedure, based on symptoms and signs and laboratory tests. Imaging examinations will be performed, if indicated, to rule out complications. Definition of the complications will be assessed on the basis of published criteria.
6 months to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasme University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Universitaire Ziekenhuizen KU Leuven
Maastricht University Medical Center
Erasmus Medical Center
Centre Hospitalier Universitaire de Nice
Amsterdam UMC, location VUmc
Leiden University Medical Center
Hospital Nord
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Teles de Campos, MD, Erasme University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ErasmeUH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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