Clinical trial Recruiting at 1 site Observational Ages 18 and up

Improving evaluation and management of patients with suspected bile duct stones

Official title: Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis

Run by University of Calgary · NCT05141916 · Data updated 2026-11-12

This study is testing a new way to improve how doctors check for and treat patients who might have stones in their bile duct.

More Choledocholithiasis trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment2000 (estimated)
SponsorUniversity of Calgary
Academic / other
Locations1 site (Calgary, Alberta)
StatusRecruiting
StartedFebruary 25, 2019
Main results expectedDecember 31, 2028
Study endsJune 30, 2029
Registry record updatedApril 29, 2026
Trial IDNCT05141916 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who are suspected of having choledocholithiasis, regardless of the probability of the condition.

Probably not a fit

Patients who are unable or unwilling to provide informed consent, those under 18 years of age, or individuals with suspected or proven cholangitis will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to optimize the evaluation and management of patients suspected of having choledocholithiasis, which involves stones in the common bile duct. The study will consist of two phases: a retrospective evaluation of 1,000 patients from 2012 to 2017 to assess the performance of current guidelines, followed by a prospective validation of a new model that incorporates dynamic liver enzyme changes into the management algorithm. The goal is to enhance the accuracy of risk stratification for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).

Why it matters

Potential benefit: If successful, this study could lead to improved patient outcomes by ensuring that only those with a high likelihood of choledocholithiasis undergo ERCP, thereby reducing unnecessary procedures and associated risks.

How similar studies have gone: Other studies have shown success in optimizing management strategies for choledocholithiasis, but this specific approach incorporating dynamic liver enzyme changes is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • University of Calgary
    Calgary, Alberta, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.