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

NCT ID: NCT06620328

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2026-12-31

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.

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

Conditions

Biliary Obstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mechanical dilator

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

Group Type: EXPERIMENTAL

endoscopic ultrasonography-guided biliary drainage

Intervention Type: 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

Electrocautery dilator

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

Group Type: ACTIVE_COMPARATOR

endoscopic ultrasonography-guided biliary drainage

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

EUS-BD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role: collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

OTHER

Sponsor Role: collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: collaborator

Chung Shan Medical University

OTHER

Sponsor Role: collaborator

Taitung Mackay Memorial Hospital

UNKNOWN

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiu-Po Wang

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Ting Kuo

Role: CONTACT

sfstruck@gmail.com

+886972652398

Hung-Yao Lin

Role: CONTACT

+886972654673

Facility Contacts

Yu-Ting Kuo

Role: primary

sfstruck@gmail.com

+886972652398

Other Identifiers

202405138RINB

Identifier Type: -

Identifier Source: org_study_id