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

Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Biliary Obstruction
• Intervention / Treatment: Procedure: endoscopic ultrasonography-guided biliary drainage

Detailed Description

1. Study background In recent years, with the advancement of endoscopy, endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly applied in cases of failed endoscopic retrograde cholangiopancreatography(ERCP). According to the European Society of Gastrointestinal Endoscopy guidelines1, in patients with malignant obstruction of the distal bile duct, if ERCP drainage fails, EUS-guided biliary drainage is superior to percutaneous transhepatic biliary drainage (PTBD). In patients with malignant obstruction of the proximal bile duct combined with left-sided bile duct dilatation, EUS-guided biliary drainage can also be considered.

   The direct transmural technique is the most common method for EUS-guided biliary drainage.2,3 Under endoscopic ultrasound guidance, the dilated bile duct is observed from the stomach or duodenum. A fine needle is then used for duct puncture, and a guidewire is advanced into the duct followed by tract dilation to create an artificial fistula. Finally, a plastic or metal stent is placed to achieve drainage. Common complications of EUS-guided drainage procedures include bleeding, intestinal perforation, bile leakage, and stent migration, with tract dilation being the most common step leading to complications.4,5 The two main methods of tract dilation are electrocautery dilation and mechanical dilation. Currently, there are only retrospective studies comparing the success rates, complications, and short- and long-term outcomes between these two methods.6 However, no any randomized controlled trial has investigated the safety and efficacy of the two traction dilation method on EUS-BD. Therefore, this study will attempt to clarify the differences in bleeding, other complications, success rates of dilation, and drainage success rates between these two dilation methods through randomized allocation.

2. Study Design Multi-center randomized clinical trial (included National Taiwan University Hospital Hsin-Chu branch, National Cheng Kung University Hospital, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Taipei Tzu Chi Hospital, Shin Kong Wu Ho Su Memorial Hospital, Far Eastern Memorial Hospital, China Medical University Hospital, Chung Shan Medical University Hospital, and Taitung Mackay Memorial Hospital) will enroll 64 patients and the study period is 12 months.

   Randomization will be done by opening sealed opaque envelopes containing computer generated random sequences in blocks of 4.

   Patients will be randomly assigned to electrocautery dilation arm vs mechanical dilation arm on 1:1 basis.

3. Subjects Consecutive patients aged more than 18 years old indicated for EUS-guided biliary drainage were included.

   Inclusion criteria ： (1) Failed ERCP (2) The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction (3) Contraindications for PTCD such as ascites and possibility of self-tube removal Exclusion criteria ： (1) Patients younger than 18 years old (2) Cancer infiltration of the gastric/duodenal wall within the planned puncture route (3) Patients with uncorrectable coagulopathy (4) Patients with unmanageable ascites (5) Patients with serious comorbidities that prohibited endoscopic management (6) Patients with pregnancy (7) Patients who cannot or refuse to provide informed consent

4. Study intervention 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 covered self-expandable metallic stents (PCSEMS) is transmurally placed.

5. Measure outcomes

Primary outcome:

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

Secondary outcomes:

• 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
• Recurrent biliary obstruction (RBO): cholangitis and jaundice accompanied by biliary dilation on imaging examinations
• Time to RBO (TRBO): the time from EUS-BD to the date of RBO occurrence
• Adverse events other than bleeding: pancreatitis, cholangitis, peritonitis, and perforation, in accordance with the American Society for GI Endoscopy lexicon7
• Length of hospital stay after procedure
• Overall survival

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Ting Kuo; Phone Number: +886972652398; Email: sfstruck@gmail.com
• Study Contact Backup: Name: Hung-Yao Lin; Phone Number: +886972654673

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yu-Ting Kuo; Phone Number: +886972652398; Email: sfstruck@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical dilator; 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; 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; Other Names: EUS-BD
Active Comparator: Electrocautery dilator; 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; 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; Other Names: EUS-BD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tract dilation success	tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct.	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	a successful deployment of a stent in the intended location	at the end of the procedure
Procedural duration	the time elapsed between puncture of the intrahepatic duct and completion of deployment of stent	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	From enrollment to 30 days after procedure
Time to Recurrent biliary obstruction	the time from EUS-BD to the date of RBO occurrence	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
Overall survival	The length of time from randomization to study completion that patients are still alive.	From date of randomization until the date of death from any cause or study completion, whichever came first, assessed up to 12 months
Length of hospital stay after procedure	The number of days patients stay in the hospital	From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 12 months
Adverse events other than bleeding	pancreatitis, cholangitis, peritonitis, and perforation, in accordance with the American Society for GI Endoscopy lexicon	From the day of randomization to the date of death or through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Shin Kong Wu Ho-Su Memorial Hospital; China Medical University Hospital; Chang Gung Memorial Hospital; National Cheng-Kung University Hospital; Far Eastern Memorial Hospital; Taichung Veterans General Hospital; Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; Chung Shan Medical University; National Taiwan University Hospital Hsin-Chu Branch; Taitung Mackay Memorial Hospital
• Investigators: Study Director: Hsiu-Po Wang, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Biliary drainage; Endoscopic ultrasound; Interventional EUS; Mechanical dilator; Electrocautery dilator
• Other Study ID Numbers: 202405138RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes