Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06620328

Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial

Led by National Taiwan University Hospital · Updated on 2026-01-13

64

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

N

National Taiwan University Hospital Hsin-Chu Branch

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to investigate the likelihood of post-dilation bleeding using mechanical or electrocautery dilation. We hypothesized that the risk of bleeding is lower in the mechanical group.

CONDITIONS

Brief Title

Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Failed ERCP
  • The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction
  • Contraindications for PTCD such as ascites and possibility of self-tube removal
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years old
  • Cancer infiltration of the gastric/duodenal wall within the planned puncture route
  • Patients with uncorrectable coagulopathy
  • Patients with unmanageable ascites
  • Patients with serious comorbidities that prohibited endoscopic management
  • Patients with pregnancy
  • Patients who cannot or refuse to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

Y

Yu-Ting Kuo

H

Hung-Yao Lin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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