EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial

Conditions
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Malignant Biliary Obstruction

Intervention / Treatment
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* Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction
* Procedure: EUS-guide biliary drainage for malignant biliary obstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ERCP assisted trans-papillary drainage<br>ERCP assisted trans-papillary drainage for malignant biliary obstruction | Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction<br>* ERCP assisted trans-papillary drainage for malignant biliary obstruction<br>|
| Active Comparator: EUS-guide biliary drainage<br>EUS-guide biliary drainage for malignant biliary obstruction | Procedure: EUS-guide biliary drainage for malignant biliary obstruction<br>* EUS-guide biliary drainage for malignant biliary obstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rates | The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures. | one month after the procedures. | 
| Adverse events rates | The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline. | within 6-9 months after the procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention rates | Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion) | within 6-9 months from the procedures | 
| Evaluation of the cost of the procedure and hospitalization. | Evaluation of the cost for different procedures. | Up to 30 days after the intervention. | 
| overall survival | death in the follow up after endoscopic treatment | within 6-9 months from the procedures |