Clinical trial NCT03812250: EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction
Official title: EUS-guided Biliary Drainage vs. ERCP Assisted Transpapillary Drainage for Malignant Biliary Obstruction: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Biliary Obstruction
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical success rates
timeFrame: one month after the procedures.
measure: Adverse events rates
timeFrame: within 6-9 months after the procedures
Secondary outcomes:
measure: Re-intervention rates
timeFrame: within 6-9 months from the procedures
measure: Evaluation of the cost of the procedure and hospitalization.
timeFrame: Up to 30 days after the intervention.
measure: overall survival
timeFrame: within 6-9 months from the procedures
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Xiaofeng Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.