Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT05141916

Conditions

Biliary Disease

Choledocholithiasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Retrograde Cholagiopancreatography (ERCP)

Study Details

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

Study ID

NCT05141916

Start date

Feb 25, 2019

Status verified date

Apr, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Endoscopic Retrograde Cholagiopancreatography (ERCP)

Endoscopic procedure employed to manage biliary and pancreatic diseases

Primary outcome measure

  • Positive or negative diagnosis of choledocholithiasis [ Time Frame: immediate ]

Central Contacts and Locations

Central contacts

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-04-29.