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

NCT03812250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2023-02-21

No results posted yet for this study

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.

Conditions

  • Malignant Biliary Obstruction

Interventions

PROCEDURE

ERCP assisted trans-papillary drainage for malignant biliary obstruction

ERCP assisted trans-papillary drainage for malignant biliary obstruction

PROCEDURE

EUS-guide biliary drainage for malignant biliary obstruction

EUS-guide biliary drainage for malignant biliary obstruction

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Xiaofeng Zhang, M.D. · First People's Hospital of Hangzhou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-02-10
Completion
2023-02-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812250 on ClinicalTrials.gov