Endoscopic Ultrasound-Guided Hepaticogastrostomy With or Without Antegrade Stenting for Malignant Distal Biliary Obstruction
Official title: Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Run by National Taiwan University Hospital · NCT07832045 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07832045 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with malignant distal biliary obstruction who failed ERCP and have inaccessible papilla due to altered anatomy or gastric outlet obstruction.
✕Probably not a fit
Patients with contraindications to endoscopic procedures, uncorrectable coagulopathy, significant ascites, pregnancy, or inability/unwillingness to consent may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial compares two endoscopic approaches for palliation of malignant distal biliary obstruction in patients with inaccessible papilla or altered anatomy. Participants are adults who previously failed ERCP and meet safety criteria. The study evaluates whether combining antegrade stenting with EUS-guided hepaticogastrostomy reduces recurrent biliary obstruction without adding unacceptable safety risks. EUS-HGAS and EUS-HGS are both performed as palliative interventions, with safety and efficacy monitored over time. The goal is to determine if the combined approach offers meaningful benefit over the standard hepaticogastrostomy alone.
Why it matters
Potential benefit: If successful, patients may experience longer-lasting biliary drainage and fewer obstruction events with a similar safety profile.
How similar studies have gone: Previous endoscopic approaches for biliary obstruction show promise, but this specific comparison between EUS-HGAS and EUS-HGS is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older with malignant distal biliary obstruction * Failed ERCP * The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction 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 it's running
-
National Taiwan University Hospital
Taipei, Taiwan Recruiting
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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.