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Completed

NCT Number: NCT03812250

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

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.

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Key information

Conditions

Malignant Biliary Obstruction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital

Hangzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP assisted trans-papillary drainage for malignant biliary obstruction

Procedure

ERCP assisted trans-papillary drainage for malignant biliary obstruction

EUS-guide biliary drainage for malignant biliary obstruction

Procedure

EUS-guide biliary drainage for malignant biliary obstruction

Primary outcomes

  1. Clinical success rates

    Time frame: one month after the procedures.

    The number of patients with total bilirubin drop more than 50 % compared with baseline after successful endoscopic procedures.

  2. Adverse events rates

    Time frame: within 6-9 months after the procedures

    The number of patients who developed adverse events, included biliary leakage, hemorrhage, perforation, cholangitis as defined and graded according to the consensus guideline.

Secondary outcomes

  1. Re-intervention rates

    Time frame: within 6-9 months from the procedures

    Number of re-interventions (ERCP or PTCD) that are necessary after successful endoscopic treatment (for example due to stent migration or stent occlusion)

  2. Evaluation of the cost of the procedure and hospitalization.

    Time frame: Up to 30 days after the intervention.

    Evaluation of the cost for different procedures.

  3. overall survival

    Time frame: within 6-9 months from the procedures

    death in the follow up after endoscopic treatment

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2019
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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