Trainee Involvement in ERCP Risk Score

Completed

• Conditions: Bile Duct Diseases; Pancreas Cancer
• Interventions: Procedure: ERCP

• Registration Number: NCT04341909
• Lead Sponsor: Clinical Hospital Colentina

Brief Summary

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

Detailed Description

The study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ERCP) conducted in a teaching setting, with trainee involvement.

It has previously shown that ERCP procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ERCP, including identifying some high risk features that might indicate that trainee involvement should not be warranted.

Briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting.

data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events.

Patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-10
• Primary Completion: 2021-09-30
• Study Completion: 2022-01-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1283

Inclusion Criteria

• patients undergoing ERCP in the participating centers
• informed consent signed prior to the procedure

Exclusion Criteria

• refusal to participate / sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trainee Group	ERCP	Patients who undergo ERCPs with trainee involvement
control group	ERCP	Patients who undergo ERCPs without any trainee involvement

Primary Outcome Measures

Name	Time	Method
any procedure related adverse outcome	30 days	including but not limited to cholangitis, perforation, bleeding, technical failure, pancreatitis

Trial Locations

Locations (1)

Colentina Clinical Hospital; 🇷🇴 Bucharest, Romania