NCT07832045

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2026Jul 2028

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

September 21, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

September 8, 2026

Last Update Submit

September 16, 2026

Conditions

Malignant Biliary ObstructionMalignant Biliary Stricture

Keywords

malignant biliary obstructionEUS-guided hepaticogastrostomyEUS-guided antegrade stentingBiliary obstruction

Outcome Measures

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

    From enrollment to the end of follow-up up to 12 months

Secondary Outcomes (8)

  • Time to Recurrent Biliary Obstruction

    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

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

  • Final procedure success

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

  • Procedural duration

    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

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

  • +3 more secondary outcomes

Study Arms (2)

HGS

ACTIVE COMPARATOR

Endoscopic ultrasound guided hepaticogastrostomy

Device: HGS

HGAS

EXPERIMENTAL

Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla

Device: HGAS

Interventions

HGASDEVICE

Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting

HGAS
HGSDEVICE

Endoscopic ultrasound guided hepaticogastromy

HGS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Ishiwatari H, Ogura T, Hijioka S, Iwashita T, Matsubara S, Ishikawa K, Niiya F, Sato J, Okuda A, Ueno S, Nagashio Y, Maruki Y, Uemura S, Notsu A. EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score-matched case-control study. Gastrointest Endosc. 2024 Jul;100(1):66-75. doi: 10.1016/j.gie.2024.02.012. Epub 2024 Feb 19.

    PMID: 38382887RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 21, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

September 21, 2026

Record last verified: 2026-08

Locations

TW(1)