Evaluating the need for repeat ERCP after treating biliary leaks
Validation of a Clinical Prediction Rule to Determine the Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks
University of Calgary · NCT05141942
This study is trying to see if patients who have had a procedure for biliary leaks really need to have another procedure to remove stents and check for leaks again.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05141942 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP) for suspected post-surgical biliary leaks. It aims to assess the necessity of performing a repeat ERCP for stent removal and cholangiogram, following standard procedures. Data will be collected prospectively by a research assistant, including patient demographics and pre-procedural information. The study seeks to clarify the best practices for managing biliary leaks and the implications of repeat ERCP procedures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing ERCP for suspected post-surgical biliary leaks.
Not a fit: Patients who have non-surgical biliary leaks or those who have previously undergone unsuccessful ERCP will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for biliary leaks, potentially reducing patient exposure to unnecessary procedures.
How similar studies have performed: While there is limited data on the necessity of repeat ERCP in this specific context, similar studies have explored ERCP effectiveness in managing biliary leaks, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients having ERCP for suspected post-surgical biliary leak; * age 18 years or older * able to give informed consent to involvement. Exclusion Criteria: * Unable or unwilling to provide informed consent; * age \< 18 years; * non-surgical biliary leak; * previous ERCP with sphincterotomy; * previous treatment or attempted treatment of biliary leak; * unsuccessful initial ERCP.
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.
Conditions: Bile Leak