Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial

N/ARecruitingNCT07832045

National Taiwan University Hospital88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Biliary Obstruction Malignant Biliary Stricture

Interventions

HGASDEVICE

Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting

HGSDEVICE

Endoscopic ultrasound guided hepaticogastromy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Recurrent biliary obstruction (RBO) rate

the proportion of participants experiencing RBO, defined by cholangitis, jaundice or findings of images, from index day of EUS-BD to the date of last follow-up

Time frame: From enrollment to the end of follow-up up to 12 months

Secondary Outcomes

Time to Recurrent Biliary Obstruction

Time frame: From date of enrollment until the date of first documented recurrent biliary obstruction, date of death from any cause or date of last follow-up, whichever came first, assessed up to 12 months

Tract dilation success

tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct

Time frame: From the start of the EUS-BD to completion or failure of dilation, assessed on the day of the drainage procedure

Final procedure success

a successful deployment of a stent in the intended location

Time frame: From the start of the EUS-BD to completion or failure of stent deployment, assessed on the day of the drainage procedure

Procedural duration

Time frame: The time elapsed between puncture of the intrahepatic duct and completion of deployment of stent, assessed on the day of the drainage procedure.

Clinical success

Time frame: a decrease in bilirubin within 14 days to < 50 % of levels before EUS-BD

Adverse events

bleeding (hematemesis and/or melena or hemoglobin drop over 2g/dL, needed blood transfusion, endoscopic hemostasis, radiological intervention or surgery), pancreatitis, cholangitis, peritonitis, and perforation, in accordance with the American Society for GI Endoscopy lexicon

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.