Quality Assessment in Endoscopic Retrograde Cholangiopancreatography(ERCP)

Completed

• Conditions: Common Bile Duct Lithiasis; Bile Duct and Pancreatic Tumors; Biliary Strictures; Cholangiopancreatography, Endoscopic Retrograde

• Registration Number: NCT02698137
• Lead Sponsor: Clinical Hospital Colentina

Brief Summary

The investigators will prospectively collect patient and procedure-related data in an observational study in order to detect patient and procedure-related risk factors for poor outcome (i.e. technical failure of the procedure; procedure-related complications).

Data will be prospectively reported using standard report forms and patients will be followed up to 30 days to detect late-onset complications.

Detailed Description

This is an investigator-driven, prospective multicenter trial which analyzes the impact of trainee participation on procedure-related outcome (technical success and procedure-related complications).

All ERCPs in the participating centers will be documented using a standard report form which will require the attending endoscopist to provide data relating to the patient (age, gender, diagnosis, bilirubin levels) and the procedure (including but not limited to the indication, technical aspects including cannulation technique, time to cannulation, degree of trainee involvement - where appropriate, procedure-related adverse events and their outcome).

Because teaching ERCP is not yet a standardized procedure, we aim to assemble a large database, stemming from the experience of several teaching centers in order to identify the main patient and operator-related factors which might influence the outcome of the procedure.

Study Timeline

• Study First Submitted: 2016-02-24
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-03
• Primary Completion: 2019-01
• Study Completion: 2019-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1843

Inclusion Criteria

• all patients undergoing ERCP with attempted cannulation of either the major or minor papilla

Exclusion Criteria

• refusal to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
procedure-related adverse events	30 days	the percentage of patients experiencing procedure-related adverse events (i.e post-ERCP pancreatitis; postERCP cholangitis; perforation; postERCP bleeding or death) occuring within 30 days of the procedure

Secondary Outcome Measures

Name	Time	Method
technical failure of the procedure	30 days	percentage of procedures where the operator was unable to achieve the desired therapeutic goal (i.e selective cannulation, stone removal, stenting)

Trial Locations

Locations (3)

GI Endoscopy Unit, Department of Gastroenterology and Hepatology, University Hospital Zagreb; 🇭🇷 Zagreb, Croatia

Endoscopia Digestiva Chirurgica, Policlinico Gemelli; 🇮🇹 Roma, Italy

Gastroenterology Department, Colentina Hospital; 🇷🇴 Bucharest, Romania