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NCT07832045
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Conditions: Malignant Biliary Obstruction, Malignant Biliary Stricture
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: National Taiwan University Hospital
Location: National Taiwan University Hospital Taipei
Summary
The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.
Eligibility 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
Source: ClinicalTrials.gov (NCT07832045). StuddyBuddy aggregates publicly available trial information.