Comparing two methods for removing large bile duct stones
A Comparison of Limited Endoscopic Sphincterotomy With Endoscopic Papillary Large Balloon Dilation vs. Endoscopic Papillary Large Balloon Dilation for Endoscopic Choledocholithiasis
NA · First People's Hospital of Hangzhou · NCT05056506
This study is testing two different ways to remove large bile duct stones to see which method is safer and works better for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou (other) |
| Locations | 2 sites (Shanghai, Shanghai and 1 other locations) |
| Trial ID | NCT05056506 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of two different approaches for treating large bile duct stones (≥10 mm): endoscopic papillary large balloon dilation (EPLBD) alone versus a combination of limited endoscopic sphincterotomy (EST) and EPLBD. The research focuses on the complications and therapeutic outcomes associated with each method, particularly in cases where traditional techniques may be less effective. By comparing these two interventions, the study seeks to determine the best approach for safely and effectively removing large stones from the bile duct.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with large bile duct stones measuring 10 mm or more.
Not a fit: Patients with contraindications to ERCP, those with benign or malignant biliary stricture, or those who have had prior EST or EPBD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with large bile duct stones.
How similar studies have performed: Previous studies have shown promising results for the efficacy of EPLBD, suggesting that this approach may be a viable alternative to traditional methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * large bile duct stones (≥10 mm) Exclusion Criteria: * pregnancy * refusal of written informed consent * Patients with benign or malignant biliary stricture * Contraindications to ERCP exist * Complicated with acute pancreatitis or acute cholangitis * Coagulation dysfunction，thrombocytopenia * prior EST or EPBD * Patients after gastrointestinal reconstruction
Where this trial is running
Shanghai, Shanghai and 1 other locations
- Shanghai Fourth People's Hospital — Shanghai, Shanghai, China (RECRUITING)
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Xiaofeng Zhang — Zhejiang University
- Study coordinator: Jianfeng Yang, Doctor
- Email: yjf-1976@163.com
- Phone: 086-13454132186
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: Choledocholithiasis, Endoscopic sphincterotomy, Endoscopic papillary balloon dilation, Complication, Safety