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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • endoscopic ultrasonography-guided biliary drainage

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National Taiwan University Hospital

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Collaborator

Taichung Veterans General Hospital

Collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborator

Far Eastern Memorial Hospital

Collaborator

China Medical University Hospital

Collaborator

Chung Shan Medical University

Collaborator

Taitung Mackay Memorial Hospital

Collaborator

National Cheng-Kung University Hospital

Collaborator

Chang Gung Memorial Hospital

Collaborator

Shin Kong Wu Ho-Su Memorial Hospital

Collaborator