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

Summary

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

• Biliary Obstruction

Interventions

PROCEDURE

endoscopic ultrasonography-guided biliary drainage

Skilled endosonographers performed EUS-BD with patients under conscious sedation by intravenous medication. All patients were given intravenous antibiotics prophylactically. A therapeutic curved linear array echoendoscope is positioned in the stomach with carbon dioxide insufflation. Standard 19G fine needles are used to puncture the dilated left intrahepatic bile duct or commo bile duct. Bile juice aspiration with 20ml syringe was performed to confirm intraductal puncture. After contrast medium injection, an insulated guidewire (0.025 inch VisiGlide2; Olympus Medical Systems, Tokyo, Japan) is advanced antegradely. Dilation of the needle tract is initially performed with a diathermic sheath (6Fr Cyst-Gastro set; Endoflex, Voerde, Germany) or an ultra-tapered mechanical dilator (7Fr ES Dilator; Zeon Medical Co., Tokyo, Japan) according to randomization result. If needed, additional dilation can be attempted with dilating balloon. Finally, the dedicated plastic stent or partially cover

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  collaborator OTHER

• Far Eastern Memorial Hospital

  collaborator OTHER

• China Medical University Hospital

  collaborator OTHER

• Chung Shan Medical University

  collaborator OTHER

• Taitung Mackay Memorial Hospital

  collaborator UNKNOWN

• National Cheng-Kung University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Shin Kong Wu Ho-Su Memorial Hospital

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Hsiu-Po Wang · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-03

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Taiwan

Study Locations