Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Diseases; Biliary Disease
• Intervention / Treatment: Other: ERCP

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 Type: Observational
• Enrollment (Actual): 2561

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
September 2013 to August 2015; 5 endoscopists	Other: ERCP; ERCPs performed annually by an endoscopist
September 2015 to December 2017; 4 endoscopists	Other: ERCP; ERCPs performed annually by an endoscopist
January 2018 to June 2020; 3 endoscopists	Other: ERCP; ERCPs performed annually by an endoscopist

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Collaborators: Complejo Hospitalario de Navarra
• Investigators: Principal Investigator: Juan J Vila, PhD, Complejo Hospitalario de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: endoscopy; ERCP; gastrointestinal; choledocholithiasis; Endoscopic Retrograde CholangioPanceratography
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Pancreatic Diseases; Gallbladder Diseases
• Other Study ID Numbers: NER20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No