GallRiks ERC Anesthesia Study

September 30, 2025 updated by: Gabriel Sandblom, Karolinska Institutet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

121252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ERCP for common bile duct stones

Description

Inclusion Criteria:

  • ERCP performed for common bile duct stones

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Swedish National Register for Gallstone Surgery and ERCP
Interventions for gallstones registered in Sweden
Procedure: Endoscopic Retrograde Cholangiopancreaticography
Anaesthesia or sedation during ERCP for common bile duct stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ERCP for retained stones performed after the primary ERCP.
Time Frame: 12 months
Retained common bile duct stones necessitating repeated ERCP within 12 months after the first ERCP
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

September 30, 2025

First Posted (Estimated)

October 3, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GallRiks ERC anesthesia study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudonymized data from the study are available on request from Gabriel Sandblom

IPD Sharing Time Frame

2025-09-18 - 2025-12-31

IPD Sharing Access Criteria

Researchers presenting their position and reason for accessing the IPD.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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