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

NCT05533944 | Completed

• 1 other identifier: ErasmeUH1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Simulation Training

Outcome Measures

Primary Outcomes (1)

• Overall trainee's competence rate

  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 Outcomes (2)

• Bile duct cannulation rate

  6 months to 12 months

• Adverse events rate

  6 months to 12 months

Study Arms (2)

Simulation group

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Trainees will undergo routine hands-on clinical ERCP training.

Interventions

Simulation training in Boškoski-Costamagna ERCP Trainer 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

Simulation group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Amsterdam UMC, location VUmc: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Hospital Nord: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Erasmus Medical Center: collaborator
• Leiden University Medical Center: collaborator
• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

Study Officials

• Sara Teles de Campos, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 9, 2022
• Study Start: September 12, 2022
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 1, 2024

Record last verified: 2022-09

Locations

IT (1)