Comparison of recurrent biliary obstruction rate among combination of ERCP plus EUS-BD (CERES) in malignant hilar biliary obstruction versus combination of ERCP plus PTBD (CERP): A prospective randomized controlled trial
Phase 3
Recruiting
- Conditions
- Malignant hilar biliary obstructionMalignant hilar biliary obstruction, Hilar Cholangiocarcinoma, Klatskin Tumor, Perihilar Cholangiocarcinoma, Endosonography, Endoscopic Ultrasonography, ERCP, EUS, EUS-guided biliary drainage (EUS-BD), Combination of EUS and ERCP (CERES), Percutaneous biliary drainage (PTBD)
- Registration Number
- TCTR20220810003
- Lead Sponsor
- Excellence Center For GI Endoscopy, King Chulalongkorn Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. Patients with unresectable malignant biliary hilar obstruction
2. Patients with indication for biliary drainage
3. Patients with good liver area of more than 80%
4. Patients with ECOG score 0-2
5. Patients with expected life expectancy of more than 3 months
6. Patients age 18-90 years
7. Patients who consent to protocol
Exclusion Criteria
1. Patients with uncorrectable coagulopathy
2. Pregnant patients
3. Patients with marked ascites which interfere with interventions
4. Patients with non-malignant biliary hilar obstruction
5. Patients who can not follow-up longer than 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method