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

NANot yet recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

October 31, 2025

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"

Trial Locations (1)

Unknown

National Taiwan University Hospital, Taipei

All Listed Sponsors
collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

collaborator

Taichung Veterans General Hospital

OTHER

collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

collaborator

Far Eastern Memorial Hospital

OTHER

collaborator

China Medical University Hospital

OTHER

collaborator

Chung Shan Medical University

OTHER

collaborator

Taitung Mackay Memorial Hospital

UNKNOWN

collaborator

National Cheng-Kung University Hospital

OTHER

collaborator

Chang Gung Memorial Hospital

OTHER

collaborator

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

lead

National Taiwan University Hospital

OTHER