Malignant Biliary ObstructionEASE-MBONCT07832045
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
A study testing HGAS and HGS in people with Malignant Biliary Obstruction and Malignant Biliary Stricture, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction, Malignant Biliary Stricture
- What is being tested?
- HGAS and HGS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Ting Kuo, 886972652398, sfstruck@gmail.com
Hung-Yao Lin, 886972653140
About this study
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.
- Being tested
- HGAS, HGS
- Keywords
- malignant biliary obstruction, EUS-guided hepaticogastrostomy, EUS-guided antegrade stenting, Biliary obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGASDevice
Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting
HGSDevice
Endoscopic ultrasound guided hepaticogastromy
| Study group | Role | What they receive |
|---|---|---|
| HGS | Active comparator | Endoscopic ultrasound guided hepaticogastrostomy Receives: Device: HGS |
| HGAS | Experimental | Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla Receives: Device: HGAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of follow-up up to 12 months
Secondary outcomes (8)
Time to Recurrent Biliary Obstruction
Measured: 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
Measured: 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
Measured: From the start of the EUS-BD to completion or failure of stent deployment, assessed on the day of the drainage procedure
Procedural duration
Measured: 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
Measured: 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
Measured: From the day of procedure to the completion of follow-up up to 12 months
Length of hospital stay after procedure
Measured: From the day of procedure to discharge, assessed up to 12 months
Overall survival
Measured: Survival rate at the end of the follow-up period, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Shin Kong Wu Ho-Su Memorial Hospital, Far Eastern Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Taitung Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832045
- Sponsor's protocol ID
- 202504093RINA
- Acronym
- EASE-MBO
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38382887
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07832045
- Acronym / sponsor ID
- EASE-MBO / 202504093RINA
- Keywords
- malignant biliary obstruction, EUS-guided hepaticogastrostomy, EUS-guided antegrade stenting, Biliary obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Hsin-Chu Branch, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Shin Kong Wu Ho-Su Memorial Hospital, Far Eastern Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Taitung Mackay Memorial Hospital, National Cheng-Kung University Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGS | Active comparator | Device: HGSEndoscopic ultrasound guided hepaticogastrostomy |
| HGAS | Experimental | Device: HGASEndoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGASEndoscopic ultrasound guided hepaticogastrostomy with antegrade stenting | Device | HGAS |
| HGSEndoscopic ultrasound guided hepaticogastromy | Device | HGS |
Primary outcome
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
8 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
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
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
Time frame: From the day of procedure to the completion of follow-up up to 12 months
Length of hospital stay after procedure
Time frame: From the day of procedure to discharge, assessed up to 12 months
Overall survival
Time frame: Survival rate at the end of the follow-up period, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 38382887Ishiwatari 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGAS and HGS in people with Malignant Biliary Obstruction and Malignant Biliary Stricture, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent biliary obstruction (RBO) rate (time frame: From enrollment to the end of follow-up up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07832045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.