Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis

NCT05141916 | Recruiting

• 1 other identifier: REB18-1053
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Choledocholithiasis (stone(s) in the common bile duct) is common. Untreated or missed, choledocholithiasis has high morbidity and mortality. Endoscopic retrograde cholangio-pancreatography (ERCP) is recognized as the first-line modality for management. While effective, ERCP is associated with adverse events. Thus, the selection of patients for ERCP should be accompanied by a high pre-test suspicion of choledocholithiasis. Choledocholithiasis is suspected based on clinical, biochemical and radiographic findings. The most relied-upon strategy for risk stratification of choledocholithiasis is based on guidelines from The American Society for Gastrointestinal Endoscopy (ASGE). In it, clinical predictors are defined as "very strong", "strong" or "moderate", and the presence of one or more of these is meant to suggest "high" or "intermediate" probability of choledocholithiasis. A knowledge gap exists in the performance characteristics of intermediate-probability criteria, where overall accuracy is \<50% from limited data. Patients in this group are recommended to a) undergo endoscopic ultrasound (EUS) or magnetic resonance cholangio-pancreatography (MRCP), b) undergo cholecystectomy with intra-operative cholangiography (IOC), or c) proceed directly to ERCP. At centres where EUS and MRCP are readily available, these are preferred options, as they are least invasive and sensitive; however, they are often unavailable. Thus, in clinical practice, a high proportion of intermediate-risk patients ultimately proceed directly to ERCP, where likelihood of benefit is only moderate, while procedural risk remains. The role of liver enzyme changes has not been evaluated; however, dynamic changes may offer another method for evaluating patients at intermediate risk of CBD stones that is safe and available. Incorporation of dynamic liver enzymes may improve the test-performance characteristics of the existing framework.

Conditions

Biliary Disease; Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• Positive or negative diagnosis of choledocholithiasis

  Retrospective analysis will be employed to determine the individual and joint test performance characteristics of the parameters in the ASGE guideline, and to determine the (lone and additional) test characteristics of dynamic enzyme changes, in predicting the primary outcome measure. The agreed-upon model will then be validated prospectively.

  immediate

Interventions

Endoscopic Retrograde Cholagiopancreatography (ERCP) PROCEDURE

Endoscopic procedure employed to manage biliary and pancreatic diseases

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

Adult patients undergoing ERCP for suspected choledocholithiasis

You may qualify if:

• Patients with suspected choledocholithiasis, regardless of probability
• age 18 years old or older
• able to give informed consent to involvement (in the prospective validation phase).

You may not qualify if:

• Unable or unwilling to provide informed consent;
• age \< 18 years;
• suspected or proven cholangitis;
• previous ERCP with sphincterotomy;
• prior diagnosis or management of choledocholithiasis;
• outpatient status;
• out-of-province status (prohibiting full medical record access).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Gallbladder Diseases; Choledocholithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nauzer Forbes, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nauzer Forbes, MD, MSc

CONTACT

403-592-5089; nauzer.forbes@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: February 25, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 5 years after data collection is complete.
• Access Criteria: Deidentified aggregate level data can be shared upon reasonable request.

Locations

CA (1)