Comparing two drainage methods for bile duct obstruction in cancer patients
A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies
This study is testing which of two methods for draining bile works better and is safer for cancer patients with blocked bile ducts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06196164 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of endoscopic ultrasound-guided biliary drainage (EUS-BD) versus endoscopic retrograde cholangiopancreatography biliary drainage (ERCP-BD) in patients with low biliary obstruction due to periampullary, pancreatic, or low bile duct cancer. It is a single-center, prospective, randomized-controlled trial focusing on stent patency time as the primary endpoint, while secondary endpoints include technical and clinical success rates, operation time, complications, reintervention rates, and postoperative survival rates. The study aims to provide insights into the best drainage strategy for patients suffering from these conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed periampullary or pancreatic cancer causing distal malignant bile duct obstruction.
Not a fit: Patients with severe cardiovascular or pulmonary diseases, uncorrectable coagulation abnormalities, or those planning for surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved drainage strategies that enhance patient outcomes and survival rates in those with biliary obstruction due to cancer.
How similar studies have performed: Other studies have shown varying success with similar drainage approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age:18 years old or above; 2. Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors; 3. Distal malignant bile duct obstruction (2cm away from the hepatic hilum); 4. Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm; 5. The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent. Exclusion Criteria: 1. Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination; 2. Uncorrectable coagulation abnormalities or bleeding tendencies (INR\>1.5 or platelets\<50) × 109 /L); 3. There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months; 4. Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures; 5. Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum; 6. Pregnancy, lactation, or planned pregnancy; 7. Refusal to join or inability to provide informed consent; 8. Other researchers evaluated the unsuitability of enrollment.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xi WU, M.D.
- Email: wxpumch@163.com
- Phone: 13683296860
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.