EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction
- Conditions
- Malignant Biliary Obstruction
- Interventions
- Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstructionProcedure: EUS-guide biliary drainage for malignant biliary obstruction
- Registration Number
- NCT03812250
- Lead Sponsor
- First People's Hospital of Hangzhou
- Brief Summary
Purpose of the study: To compare efficacy, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events between EUS-guide biliary drainage (EUS-BD) and ERCP assisted trans-papillary drainage for malignant biliary obstruction.
Subjects of the study: Patients who have malignant biliary obstruction.
Methods of the study:
* Prospective randomized controlled study
* Patients were randomly divided into two groups, EUS-BD group or ERCP group
* Patients will get assigned procedure (EUS-BD or ERCP assisted trans-papillary drainage)for decompression of malignant biliary obstruction
* After the procedure, regular follow up, blood test, and imaging test will be done to check sufficient biliary decompression, stent patency, re-intervention rate, cost, quality of life, survival time, and adverse events rate.
Statistical methods: SPSS 23.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.
- Detailed Description
ERCP is a well-established procedure for the management of malignant biliary obstruction. However, even in expert hands, ERCP fails in 3%-5% of cases, especially in patients with surgically altered anatomy or difficult biliary cannulation. In these cases, more invasive options are usually considered, which including percutaneous trans-hepatic biliary drainage and surgical intervention, but they all have been associated with a higher risk of complications and prolonged hospital stay. EUS-guide biliary drainage using a metal stent, particularly a lumen-apposing metal stent, is a promising technique for biliary decompression in patients with failed ERCP. There has been growing global experience with EUS-BD in recent years, and data from expert centers support the feasibility and efficacy of EUS-BD. However, few researches compared the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction. The investigators herein aim to conduct a randomized controlled clinical trial to compare the efficacy and complication rates between EUS-BD and ERCP for malignant biliary obstruction.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- age: 18 - 85 years
- a patients who had malignant biliary obstruction confirmed by imaging examinations and Pathological examination
- Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl)
- inoperable state
- patients who agree to join this study
- a patients who cannot endure sedation or therapeutic endoscopic procedure
- a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000)
- patients underwent biliary drainage by surgery, ERCP or percutaneous transhepatic biliary drainage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ERCP assisted trans-papillary drainage ERCP assisted trans-papillary drainage for malignant biliary obstruction ERCP assisted trans-papillary drainage for malignant biliary obstruction EUS-guide biliary drainage EUS-guide biliary drainage for malignant biliary obstruction EUS-guide biliary drainage for malignant biliary obstruction
- Primary Outcome Measures
Name Time Method Clinical success rates one month after the procedures. The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.
Adverse events rates within 6-9 months after the procedures The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.
- Secondary Outcome Measures
Name Time Method overall survival within 6-9 months from the procedures death in the follow up after endoscopic treatment
Re-intervention rates within 6-9 months from the procedures Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)
Evaluation of the cost of the procedure and hospitalization. Up to 30 days after the intervention. Evaluation of the cost for different procedures.
Trial Locations
- Locations (1)
Hangzhou First People's Hospital
🇨🇳Hangzhou, China