Health TrialsbyHealthPanel

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

ConditionsMalignant Biliary ObstructionMalignant Biliary Stricture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HGAS

    Device

    Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting

  • HGS

    Device

    Endoscopic ultrasound guided hepaticogastromy

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: HGSActive comparator 1 intervention
Group B: HGASExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

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
3

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
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Collaborator

Chang Gung Memorial Hospital

Collaborator

Taichung Veterans General Hospital

Collaborator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Collaborator

Shin Kong Wu Ho-Su Memorial Hospital

Collaborator

Far Eastern Memorial Hospital

Collaborator

China Medical University Hospital

Collaborator

Chung Shan Medical University

Collaborator

Taitung Mackay Memorial Hospital

Collaborator

National Cheng-Kung University Hospital

Collaborator

Source ClinicalTrials.gov
Apply now