EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Clinical success rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Clinical success rates
Time Frame: 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
Time Frame: 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 Outcomes
- overall survival(within 6-9 months from the procedures)
- Re-intervention rates(within 6-9 months from the procedures)
- Evaluation of the cost of the procedure and hospitalization.(Up to 30 days after the intervention.)
Investigators
Jianfeng Yang
Hangzhou First People's Hospital
First People's Hospital of Hangzhou