Comparing Mechanical and Electrocautery Dilators for Endoscopic Ultrasound-Guided Biliary Drainage to Assess Safety and Effectiveness

What this Trial Is About

The trial investigates the safety and effectiveness of mechanical versus electrocautery dilators used during endoscopic ultrasound-guided biliary drainage EUS-BD for patients with biliary obstruction. This procedure is considered when standard ERCP drainage fails, especially in cases of malignant bile duct obstruction. The study aims to compare bleeding risks, complications, and success rates between the two dilation methods through randomized allocation in a multicenter setting. Participants undergo EUS-BD performed by experienced endosonographers under conscious sedation. The procedure involves puncture of the bile duct followed by tract dilation using either a mechanical dilator or an electrocautery dilator, assigned randomly. Additional dilation with a balloon may be used if needed, and a plastic or metal stent is placed to facilitate drainage. The study enrolls 64 patients and spans 12 months, with randomization done in blocks of four. Participants will be monitored for bleeding events, procedure success, clinical outcomes, and adverse events for up to one year after the procedure. Assessments include bleeding requiring intervention, dilation success, stent placement success, bilirubin levels, recurrent biliary obstruction, procedure duration, hospital stay length, and overall survival. Safety and efficacy data will be collected through clinical evaluations and imaging, with follow-up extending to one year post-procedure to capture long-term outcomes.

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