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

Malignant Biliary Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812250
• Other study ID #: 2018
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 15, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Biliary Obstruction

Intervention

Procedure:
• ERCP assisted trans-papillary drainage for malignant biliary obstruction
ERCP assisted trans-papillary drainage for malignant biliary obstruction
• EUS-guide biliary drainage for malignant biliary obstruction
EUS-guide biliary drainage for malignant biliary obstruction

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	Evaluation of the cost of the procedure and hospitalization.	Evaluation of the cost for different procedures.	Up to 30 days after the intervention.
Secondary	overall survival	death in the follow up after endoscopic treatment	within 6-9 months from the procedures