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.
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
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
Parallel
endoscopic ultrasonography-guided biliary drainage
Procedure/SurgerySkilled 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
Bleeding
hematemesis and/or melena or hemoglobin drop over 2g/dL, needed blood transfusion, endoscopic hemostasis, radiological intervention or surgery
Tract dilation success
tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct.
Final procedure success
a successful deployment of a stent in the intended location
Procedural duration
the time elapsed between puncture of the intrahepatic duct and completion of deployment of stent
Clinical success
a decrease in bilirubin within 30 days to \< 75 % of levels before EUS-BD
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National Taiwan University Hospital
Lead sponsor
National Taiwan University Hospital Hsin-Chu Branch
Collaborator
Taichung Veterans General Hospital
Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Collaborator
Far Eastern Memorial Hospital
Collaborator
China Medical University Hospital
Collaborator
Chung Shan Medical University
Collaborator
Taitung Mackay Memorial Hospital
Collaborator
National Cheng-Kung University Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator
