Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

Completed

• Conditions: Biliary Disease; Pancreatic Diseases
• Interventions: Other: ERCP

• Registration Number: NCT04705740
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.

Detailed Description

The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.

The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.

To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).

The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-31
• Study First Submitted: 2020-12-11
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-11
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2561

Inclusion Criteria

• patients undergoing ERCP with written informed consent given
• Staff allocated in the endoscopy unit

Exclusion Criteria

• Rejection to participate in the study
• ERCP procedures performed by fellows in training

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
September 2013 to August 2015	ERCP	5 endoscopists
September 2015 to December 2017	ERCP	4 endoscopists
January 2018 to June 2020	ERCP	3 endoscopists

Primary Outcome Measures

Name	Time	Method
Adverse effects	Up to 1 month after intervention	Rate of adverse effect assessed by the ASGE classification
Papillary cannulation	During the procedure	Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically

Secondary Outcome Measures

Name	Time	Method
Complexity level of ERCP	During the ERCP procedure	Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures
Individual adverse effects	Up to 1 month after intervention	Rate of individual adverse effect during the intervention
Therapeutics performed with ERCP	During the ERCP procedure	Techniques used during ERCP

Trial Locations

Locations (1)

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain