Improving evaluation and management of patients with suspected bile duct stones
Optimizing the Evaluation and Management of Patients With Suspected Choledocholithiasis
This study is testing a new way to improve how doctors check for and treat patients who might have stones in their bile duct.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05141916 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in optimizing management strategies for choledocholithiasis, but this specific approach incorporating dynamic liver enzyme changes is novel.
Eligibility criteria
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 this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Nauzer Forbes, MD, MSc — University of Calgary
- Study coordinator: Nauzer Forbes, MD, MSc
- Email: nauzer.forbes@ucalgary.ca
- Phone: 403-592-5089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.