ERCP with covered metallic stents versus EUS-guided hepaticogastrostomy for unresectable distal Malignant Biliary Obstruction (RUMBO): A prospective randomized controlled trial
- Conditions
- Patients with unresectable cancer causing distal bile duct obstruction requiring, suitable for and would undergo endoscopic biliary drainage.EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP), malignant distal biliary obstruction (MDBO)
- Registration Number
- TCTR20240601003
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Patients with unresectable cancer causing distal bile duct obstruction requiring, suitable for and would undergo endoscopic biliary drainage.
Patients in a reasonably good physical condition (ECOG2).
Patients with life expectancy longer than 6 months.
Patients with viable liver volume more than 80%.
Patients without preceding hepatectomy or atrophic liver.
Patients without cirrhosis child B or C.
Patients without significant ascites that might preclude EUS-HGS.
Exclusion Criteria
Exclusion criteria
Patients with hilar bile duct obstruction.
Patients with abnormal blood clotting or platelet function that cannot be corrected (INR < 1.5 or platelet count <50,000).
Pregnant patients.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in the 6-month RBO rate between the self-expanding metal stent placed to treat bile duct obstruction due to cancer using ERCP technique and the EUS-HGS technique at 6 months after end of the intervention EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP)
- Secondary Outcome Measures
Name Time Method The differences in the technical success rate, clinical success rate, survival rate, patency time, quality of life, and incidence of adverse events at 6 months after end of the intervention EUS-guided hepaticogastrostomy (EUS-HGS), endoscopic retrograde cholangiopancreatography (ERCP)