Comparing two methods for treating large bile duct stones
Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones
NA · Sohag University · NCT06106724
This study is testing whether a new technique for removing large bile duct stones works better than the standard method to help reduce complications for patients undergoing the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT06106724 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two techniques for managing large common bile duct stones: primary precutting sphincterotomy and conventional over-the-wire sphincterotomy. The study aims to determine which method is more effective in reducing complications, particularly post-ERCP pancreatitis, which is a significant risk associated with endoscopic retrograde cholangiopancreatography (ERCP). Patients with difficult biliary access who consent to participate will be randomly assigned to one of the two intervention groups. The trial seeks to improve patient outcomes by potentially lowering the incidence of serious complications during the procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing difficult biliary access who require biliary cannulation without a history of previous sphincterotomy.
Not a fit: Patients with coagulopathy or acute pancreatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective approach for patients undergoing treatment for large bile duct stones.
How similar studies have performed: While there have been various approaches to reduce complications in ERCP, this specific comparison of precutting versus conventional methods is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with difficult biliary access (DBA) consenting to randomization in an interventional design randomized controlled trials (RCTs) that compare precut sphincterotomy (EPS) with persistent cannulation attempts (PCA). * Patients who required biliary cannulation but without previous sphincterotomy. Exclusion Criteria: -Patients with coagulopathy or acute pancreatitis.
Where this trial is running
Sohag
- Sohag university Hospital — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: ahmed B abdelazeam, assistant lecutrer
- Email: ahmed_ahmed5@med.sohag.edu.eg
- Phone: 01015700097
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: Calcular Obstructive Jaundice