Comparing endoscopic scissors cutting nasobiliary ducts to bilateral plastic stents for treating bile duct issues
The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis
This study is testing if using endoscopic scissors to cut nasobiliary ducts can help patients with bile duct problems feel better compared to the usual plastic stents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06106750 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and safety of using endoscopic scissors to cut nasobiliary ducts in patients with malignant hilar biliary tract stenosis. The research aims to improve palliative treatment options for patients who have lost the chance for surgical resection due to late diagnosis. By utilizing nasobiliary ducts, the study seeks to enhance drainage and potentially improve patient outcomes compared to traditional bilateral plastic stents. Participants will undergo endoscopic retrograde cholangiopancreatography (ERCP) as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with clinically confirmed malignant hilar biliary duct stenosis who are scheduled for ERCP.
Not a fit: Patients with multiple organ dysfunction, prior biliary drainage, current cholangitis, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and survival time for patients with malignant hilar biliary tract stenosis.
How similar studies have performed: While this approach is innovative, it builds on existing techniques in endoscopic drainage, and similar studies have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis 2. Clinically and pathologically confirmed malignant hilar biliary duct stenosis 3. MRCP determines Bismuth classification: II-IV type 4. Comply with research procedures and sign the informed consent form Exclusion Criteria: 1. The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment 2. The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical) 3. The patient is currently suffering from cholangitis 4. The patient is participating in other clinical trials 5. Inability to provide informed consent
Where this trial is running
Hangzhou, Zhejiang
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jianfeng Yang, Doctor — First People's Hospital of Hangzhou
- Study coordinator: Jianfeng Yang, Doctor
- Email: yjf-1976@163.com, yjf3303@zju.edu.cn
- Phone: (+86)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.