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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Sep 26, 2024

Keywords

ClinConnect Summary

The MED-BD clinical trial is exploring two methods for treating a condition called biliary obstruction, where the bile ducts are blocked. Specifically, the study is comparing two types of tools used to help clear these blockages: a mechanical dilator and an electrocautery dilator. The main goal is to find out if one method causes less bleeding after the procedure than the other, with the belief that the mechanical method may be safer.

To participate in this trial, individuals need to be between 65 and 74 years old and have already had difficulties with a standard procedure called ERCP. They should not have certain health issues that could complicate treatment, such as serious bleeding disorders or pregnancy. The study is not yet recruiting participants, but if someone is eligible, they can expect to be closely monitored during the trial to ensure their safety and gather important information on how well each method works. This trial could help provide better treatment options for patients facing biliary obstructions in the future.

Gender

ALL

Eligibility criteria

• 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