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

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

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.

Study Overview

• Status: Completed
• Conditions: Malignant Biliary Obstruction
• Intervention / Treatment: Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction; Procedure: EUS-guide biliary drainage for malignant biliary obstruction

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hangzhou, China
    • Hangzhou First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ERCP assisted trans-papillary drainage; ERCP assisted trans-papillary drainage for malignant biliary obstruction	Procedure: ERCP assisted trans-papillary drainage for malignant biliary obstruction; ERCP assisted trans-papillary drainage for malignant biliary obstruction
Active Comparator: EUS-guide biliary drainage; EUS-guide biliary drainage for malignant biliary obstruction	Procedure: EUS-guide biliary drainage for malignant biliary obstruction; EUS-guide biliary drainage for malignant biliary obstruction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Principal Investigator: Xiaofeng Zhang, M.D., First People's Hospital of Hangzhou

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No