GallRiks ERC Anesthesia Study

NCT07205380 | Completed

• 1 other identifier: GallRiks ERC anesthesia study
• Study Type: observational
• Target: 121,252
• Locations: 0 countries
• Sites: N/A

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones (CBDS) removal can be performed under varying levels of sedation. Deeper sedation has been associated with more successful cannulation, but little is known about the efficacy of ERCP measured as rate of retained CBDS depending on the level of sedation. In this population-based, cohort study, using prospectively assembled register data from 121 252 ERCP procedures, adjusted odds ratio (OR) of retained CBDS 12 months after CBDS removal are analysed. Retained CBDS are defined as a repeated ERCP where CBDS are found.

Conditions

Gallstone Disease

Keywords

gallstone; ERCP; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of ERCP for retained stones performed after the primary ERCP.

  Retained common bile duct stones necessitating repeated ERCP within 12 months after the first ERCP

  12 months

Study Arms (1)

Swedish National Register for Gallstone Surgery and ERCP

Interventions for gallstones registered in Sweden

Procedure: Endoscopic Retrograde Cholangiopancreaticography

Interventions

Endoscopic Retrograde Cholangiopancreaticography PROCEDURE

Anaesthesia or sedation during ERCP for common bile duct stones

Swedish National Register for Gallstone Surgery and ERCP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ERCP for common bile duct stones

You may qualify if:

• ERCP performed for common bile duct stones

You may not qualify if:

• Suspicion of bile duct tumour
• ERCP performed during the seanse as a cholecystectomy
• Patients having undergone ERCP previously

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Cholelithiasis; Gallstones

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2007
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2025-09-18 - 2025-12-31
• Access Criteria: Researchers presenting their position and reason for accessing the IPD.