Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage (MED-BD)
Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial
National Taiwan University Hospital
64 participants
Jul 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
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
Locations(1)
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NCT06620328