Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

Pancreatic Diseases Clinical Trial

Official title:

Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04705740
• Other study ID #: NER20
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2021
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2561
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease
• Gallbladder Diseases
• Pancreatic Diseases

Intervention

Other:
• ERCP
ERCPs performed annually by an endoscopist

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Complejo Hospitalario de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Papillary cannulation	Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically	During the procedure
Primary	Adverse effects	Rate of adverse effect assessed by the ASGE classification	Up to 1 month after intervention
Secondary	Individual adverse effects	Rate of individual adverse effect during the intervention	Up to 1 month after intervention
Secondary	Complexity level of ERCP	Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures	During the ERCP procedure
Secondary	Therapeutics performed with ERCP	Techniques used during ERCP	During the ERCP procedure