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

NCT06620328 | Recruiting DMC

• 1 other identifier: 202405138RINB
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary Obstruction

Keywords

Endoscopic ultrasound; Biliary drainage; Mechanical dilator; Electrocautery dilator; Interventional EUS

Outcome Measures

Primary Outcomes (1)

• Bleeding

  hematemesis and/or melena or hemoglobin drop over 2g/dL, needed blood transfusion, endoscopic hemostasis, radiological intervention or surgery

  From randomization to four weeks after the procedure

Secondary Outcomes (8)

• Tract dilation success

  From randomization to successful tract dilation using the first device (success), to using other dilation devices (fail) or to procedure termination (fail)

• Final procedure success

  at the end of the procedure

• Procedural duration

  between puncture of the intrahepatic duct and completion of deployment of stent

• Clinical success

  From enrollment to 30 days after procedure

• Time to Recurrent biliary obstruction

  From the day of technically successful biliary drainage to the day of recurrent obstruction or to study completion an average of 1 year, whichever comes first

Study Arms (2)

Mechanical dilator

EXPERIMENTAL

Dilation of the needle tract is initially performed with an ultra-tapered mechanical dilator (7Fr ES Dilator; Zeon Medical Co., Tokyo, Japan).

Procedure: endoscopic ultrasonography-guided biliary drainage

Electrocautery dilator

ACTIVE COMPARATOR

Dilation of the needle tract is initially performed with a diathermic sheath (6Fr Cyst-Gastro set; Endoflex, Voerde, Germany).

Procedure: endoscopic ultrasonography-guided biliary drainage

Interventions

endoscopic ultrasonography-guided biliary drainage PROCEDURE

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

Also known as: EUS-BD

Electrocautery dilator; Mechanical dilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• 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

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Hsiu-Po Wang

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu-Ting Kuo

CONTACT

+886972652398; sfstruck@gmail.com

Hung-Yao Lin

CONTACT

+886972654673

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: July 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)