Malignant Biliary ObstructionNCT05169398
EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
A study testing EUS-guided hepaticogastrostomy in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- EUS-guided hepaticogastrostomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2022to 30 Nov 2026
- 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
- >= 18 years of age
- Anatomically feasible for EUS-guided hepatico-gastrostomy
- Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
- Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
- Written informed consent (and assent when applicable) obtained from subject.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Coagulopathic patients (INR>1.5, platelets <50,000)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Surgery, Prince of Wales Hospital
Hong Kong
Anthony YB Teoh, FRCSEd(Gen), 35052956, anthonyteoh@surgery.cuhk.edu.hk
Anthony YB Teoh
About this study
EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety.
The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.
Read the detailed description
This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.
EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.
Outcome parameters include safety, technical and clinical success
- Conditions
- Malignant Biliary Obstruction
- Being tested
- EUS-guided hepaticogastrostomy
- Keywords
- Malignant Biliary Obstruction, EUS-biliary drainage, EUS-guided hepaticogastrostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided hepaticogastrostomyDevice
EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea)
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided hepaticogastrostomy | Experimental | EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea). Receives: Device: EUS-guided hepaticogastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics
Measured: 30 day
Secondary outcomes (3)
Number of patients with technical success
transmural placement of the stent across the stomach or duodenum into the bile duct
Measured: 1 day
Number of patients with Clinical success
decrease of >20% bilirubin from baseline level
Measured: 7 days
Stent patency
the period between stent insertion and stent occlusion or stent removal
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start15 Jan 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Chinese University of Hong KongThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169398
- Sponsor's protocol ID
- CRE-2021.447
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ogura T, Ueno S, Okuda A, Nishioka N, Yamada M, Matsuno J, Ueshima K, Yamamoto Y, Higuchi K. Technical feasibility and safety of one-step deployment of EUS-guided hepaticogastrostomy using an 8-mm diameter metal stent with a fine-gauge stent delivery system (with video). Endosc Ultrasound. 2021 Sep-Oct;10(5):355-360. doi: 10.4103/EUS-D-20-00206.
PubMed 34427190Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl-2017-314341. Epub 2018 Feb 20.
PubMed 29463614
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent
- ClinicalTrials.gov ID
- NCT05169398
- Acronym / sponsor ID
- CRE-2021.447
- Conditions
- Malignant Biliary Obstruction
- Keywords
- Malignant Biliary Obstruction, EUS-biliary drainage, EUS-guided hepaticogastrostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 27 Dec 2021 (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.
EUS-guided biliary drainage is gaining popularity as a means of achieving endoscopic drainage in patients with failed endoscopic retrograde cholangiopancreatography (ERCP) 1. EUS-guided hepaticogastrostomy (HGS) is a type of EUS-guided biliary drainage and the procedure is employed when the ERCP fails due to a malignant bile duct obstruction but the papilla is inaccessible or if the first of the duodenum is infiltrated by tumor. Recently, a novel dedicated HGS (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) has become available, the stent has a novel design to that prevents the stent from migration, further improving the safety.
The aim of the current study is to evaluate the feasibility and outcomes of the novel lumen apposing stent for EUS-guided HGS. The hypothesis is that the device is safe and effective.
Detailed description
This is a prospective feasibility study enrolling patients suffering from malignant biliary obstruction with failed or anticipated difficult ERCP. Consecutive patients satisfying the inclusion criteria would be recruited.
EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent. The MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) is a novel device designed for hepaticogastrostomy. The stent is a partially covered metal stent made by nitinol covered with silicone. One end of the stent is uncovered and designed for placement in the intrahepatic ducts. The other end has a self-folding design that creates a flange and prevents migration of the stent outside the stomach. The stent diameter is either 8 or 10mm and the length can be 6,8,10 or 12cm long.
Outcome parameters include safety, technical and clinical success
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- EUS-guided hepaticogastrostomy would be performed with the MG-biliary stent
| Arm | Type | Receives |
|---|---|---|
| EUS-guided hepaticogastrostomy | Experimental | Device: EUS-guided hepaticogastrostomyEUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 18 years of age
- Anatomically feasible for EUS-guided hepatico-gastrostomy
- Patients with clinical symptoms and/or signs of extrahepatic biliary obstruction (jaundice, biliary-type pain, cholangitis)
- Patients with unsuccessful ERCP (failed ERCP, anticipated difficult ERCP or high risk for pancreatitis)
- Written informed consent (and assent when applicable) obtained from subject.
Key exclusion criteria (2 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Coagulopathic patients (INR>1.5, platelets <50,000)
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 |
|---|---|---|
| EUS-guided hepaticogastrostomyEUS-guided hepaticogastrostomy would be performed with the MG-biliary stent (Niti-S, Taewoong Medical, Gyeonggi-do, Korea) | Device | EUS-guided hepaticogastrostomy |
Primary outcome
Adverse event
Time frame: 30 day
a life-threatening or severe event requiring endoscopic and/or surgical intervention, transfusion or IV/IM antibiotics
3 secondary outcomes
Number of patients with technical success
Time frame: 1 day
Number of patients with Clinical success
Time frame: 7 days
Stent patency
Time frame: 1 year
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 20 Mar 2026.
- Background: PubMed 34427190Ogura T, Ueno S, Okuda A, Nishioka N, Yamada M, Matsuno J, Ueshima K, Yamamoto Y, Higuchi K. Technical feasibility and safety of one-step deployment of EUS-guided hepaticogastrostomy using an 8-mm diameter metal stent with a fine-gauge stent delivery system (with video). Endosc Ultrasound. 2021 Sep-Oct;10(5):355-360. doi: 10.4103/EUS-D-20-00206.
- Results publication: PubMed 29463614Teoh AYB, Dhir V, Kida M, Yasuda I, Jin ZD, Seo DW, Almadi M, Ang TL, Hara K, Hilmi I, Itoi T, Lakhtakia S, Matsuda K, Pausawasdi N, Puri R, Tang RS, Wang HP, Yang AM, Hawes R, Varadarajulu S, Yasuda K, Ho LKY. Consensus guidelines on the optimal management in interventional EUS procedures: results from the Asian EUS group RAND/UCLA expert panel. Gut. 2018 Jul;67(7):1209-1228. doi: 10.1136/gutjnl-2017-314341. Epub 2018 Feb 20.
- Individual participant dataSharing planned: No
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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 EUS-guided hepaticogastrostomy in people with Malignant Biliary Obstruction, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 2 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 20 Mar 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 Hong Kong. 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?
Contact Anthony Teoh, FRCSEd (35052956, anthonyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: 30 day). 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 NCT05169398, which also lists 2 linked publications.
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 20 Mar 2026.