EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
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Interventional model
Masking
88 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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