EUS-guided procedure for treating bile duct obstructions
Official title: EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
Run by Chinese University of Hong Kong · NCT05169398 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | January 15, 2022 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT05169398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old with clinical symptoms of biliary obstruction and a history of unsuccessful ERCP.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have coagulopathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Endoscopic Ultrasound-Guided Hepaticogastrostomy With or Without Antegrade Stenting for Malignant Distal Biliary Obstruction
This trial tests whether adding antegrade stenting to EUS-guided hepaticogastrostomy helps longer-lasting relief of malignant distal biliary obstruction compared with hepaticogastrostomy alone in adults who cannot have ERCP.
-
12-mm Partially Covered vs Bare Self-Expandable Stents for Malignant Distal Biliary Obstruction
This study tests whether a 12-mm partially covered self-expandable stent works better than a 12-mm bare self-expandable stent for patients with unresectable malignant distal biliary obstruction who have already had PTBD.
-
Suprapapillary Metal Stent vs. Routine Drainage for Malignant Hilar Biliary Obstruction
This trial tests whether placing a self-expanding metal stent above the papilla works better than the standard transpapillary drainage for patients with cancer-caused bile duct blockage near the liver.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.