Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography

NCT04705740 | Completed DMC

• 1 other identifier: NER20
• Study Type: observational
• Target: 2,561
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Biliary Disease; Pancreatic Diseases

Keywords

ERCP; endoscopy; gastrointestinal; choledocholithiasis; Endoscopic Retrograde CholangioPanceratography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Individual adverse effects

  Up to 1 month after intervention

• Complexity level of ERCP

  During the ERCP procedure

• Therapeutics performed with ERCP

  During the ERCP procedure

Study Arms (3)

September 2013 to August 2015

5 endoscopists

Other: ERCP

September 2015 to December 2017

4 endoscopists

Other: ERCP

January 2018 to June 2020

3 endoscopists

Other: ERCP

Interventions

ERCP OTHER

ERCPs performed annually by an endoscopist

January 2018 to June 2020; September 2013 to August 2015; September 2015 to December 2017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Complejo Hospitalario de Navarra: collaborator

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Gallbladder Diseases; Pancreatic Diseases; Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Juan J Vila, PhD

  Complejo Hospitalario de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: January 12, 2021
• Study Start: September 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)