RecruitingNot Applicable

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

Taiwan64 participantsStarted 2025-07-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Bleeding

Timeframe: From randomization to four weeks after the procedure

Trial details

NCT IDNCT06620328

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Yu-Ting Kuo

+886972652398 sfstruck@gmail.com

View on ClinicalTrials.gov More Biliary Obstruction trials