Mechanical versus electrocautery dilator for EUS-guided biliary drainage
Safety and Efficacy of Mechanical Versus Electrocautery Dilator for EUS-guided Biliary Drainage: A Prospective Randomized Controlled Trial
This trial will test whether using a mechanical dilator instead of an electrocautery dilator reduces bleeding during EUS-guided biliary drainage for patients with biliary obstruction after failed ERCP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06620328 on ClinicalTrials.gov |
What this trial studies
Patients who require endoscopic ultrasound-guided biliary drainage after failed ERCP will undergo tract dilation with either a mechanical dilator or an electrocautery dilator and be followed for bleeding and other complications. The procedure uses EUS to puncture the dilated bile duct, place a guidewire, dilate the tract, and insert a stent for drainage. The primary focus is comparing post-dilation bleeding rates between the two dilation methods, along with procedural success and other adverse events. Data so far are mostly retrospective, so prospective comparison in this population aims to clarify relative safety.
Who should consider this trial
Good fit: Ideal candidates are adults with biliary obstruction who have failed ERCP or have an inaccessible papilla due to altered anatomy or gastric outlet obstruction and who are eligible for EUS-guided biliary drainage without uncorrectable coagulopathy or unmanageable ascites.
Not a fit: Patients with uncorrectable coagulopathy, unmanageable ascites, cancer infiltrating the planned puncture route, serious comorbidities prohibiting endoscopic management, pregnancy, minors, or those who refuse consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the mechanical dilator approach could lower the risk of post-dilation bleeding and make EUS-guided biliary drainage safer for patients.
How similar studies have performed: Only retrospective studies have directly compared mechanical and electrocautery dilation, so prospective evidence remains limited though retrospective data suggest differences in complication profiles.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Yu-Ting Kuo
- Email: sfstruck@gmail.com
- Phone: +886972652398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.