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NCT Number: NCT07832045

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

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.

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Key information

Conditions

Malignant Biliary Obstruction Malignant Biliary Stricture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGAS

Device

Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting

HGS

Device

Endoscopic ultrasound guided hepaticogastromy

Primary outcomes

  1. Recurrent biliary obstruction (RBO) rate

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

    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

Secondary outcomes

  1. 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

  2. Tract dilation success

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

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

  3. Final procedure success

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

    a successful deployment of a stent in the intended location

  4. 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.

  5. Clinical success

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

  6. Adverse events

    Time frame: From the day of procedure to the completion of follow-up up to 12 months

    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

  7. Length of hospital stay after procedure

    Time frame: From the day of procedure to discharge, assessed up to 12 months

  8. Overall survival

    Time frame: Survival rate at the end of the follow-up period, assessed up to 12 months

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Chung Shan Medical University
  • Far Eastern Memorial Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital Hsin-Chu Branch
  • Shin Kong Wu Ho-Su Memorial Hospital
  • Taichung Veterans General Hospital
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
  • Taitung Mackay Memorial Hospital

Registry information

Acronym: EASE-MBO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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