EUS-guided procedure for treating bile duct obstructions
EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
This study is testing a new type of stent to help people with bile duct blockages who couldn't get relief from a standard procedure, to see if it works better and is safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05169398 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and outcomes of a novel lumen apposing metal stent for EUS-guided hepaticogastrostomy in patients with malignant biliary obstruction who have had unsuccessful endoscopic retrograde cholangiopancreatography (ERCP). The procedure aims to provide an alternative drainage method when ERCP fails due to inaccessible papilla or tumor infiltration. The study will assess the safety and effectiveness of the new stent design, which is intended to prevent migration and improve patient outcomes. Patients will be recruited based on specific inclusion criteria and monitored for technical and clinical success.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with clinical symptoms of biliary obstruction and a history of unsuccessful ERCP.
Not a fit: Patients who are pregnant, breastfeeding, or have coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with malignant biliary obstruction.
How similar studies have performed: While EUS-guided biliary drainage is gaining popularity, this specific approach with the novel stent design is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \>= 18 years of age 2. Anatomically feasible for EUS-guided hepatico-gastrostomy 3. Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis) 4. Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis) 5. Written informed consent (and assent when applicable) obtained from subject. Exclusion Criteria: 1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. Coagulopathic patients (INR\>1.5, platelets \<50,000)
Where this trial is running
Hong Kong
- Department of Surgery, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Anthony Teoh, FRCSEd
- Email: anthonyteoh@surgery.cuhk.edu.hk
- Phone: 35052956
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.