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

NCT ID: NCT03812250

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-02-15

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.

Conditions

Malignant Biliary Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ERCP assisted trans-papillary drainage

ERCP assisted trans-papillary drainage for malignant biliary obstruction

Group Type: ACTIVE_COMPARATOR

ERCP assisted trans-papillary drainage for malignant biliary obstruction

Intervention Type: PROCEDURE

ERCP assisted trans-papillary drainage for malignant biliary obstruction

EUS-guide biliary drainage

EUS-guide biliary drainage for malignant biliary obstruction

Group Type: ACTIVE_COMPARATOR

EUS-guide biliary drainage for malignant biliary obstruction

Intervention Type: PROCEDURE

EUS-guide biliary drainage for malignant biliary obstruction

Interventions

ERCP assisted trans-papillary drainage for malignant biliary obstruction

ERCP assisted trans-papillary drainage for malignant biliary obstruction

Intervention Type: PROCEDURE

EUS-guide biliary drainage for malignant biliary obstruction

EUS-guide biliary drainage for malignant biliary obstruction

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Yang

Hangzhou First People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaofeng Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

Hangzhou First People's Hospital

Hangzhou, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 29605722 (View on PubMed)

Other Identifiers

2018

Identifier Type: -

Identifier Source: org_study_id