Gastric Varices BleedingNCT07049146
Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding
A study testing EUS-guided tissue glue/coil injection and BRTO in people with Gastric Varices Bleeding, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Varices Bleeding
- What is being tested?
- EUS-guided tissue glue/coil injection and BRTO
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old;
- Liver cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy);
- Experienced bleeding of gastroesophageal varices (GVs) (GOV1, GOV2, or IGV1) within 5 days to 1 year (bleeding lesions observed under endoscopy originating from GVs, or no other bleeding lesions except GVs were found);
- Presence of spontaneous portosystemic shunts that are technically feasible for BRTO; ⑤ Willing to participate in this clinical study, comply with the study requirements, and sign the informed consent form.
Who cannot join
- Previously received vascular interventional therapy for preventing rebleeding of GVs;
- Eligible for variceal ligation treatment of GOV1;
- Non-cirrhotic portal hypertension (including regional portal hypertension);
- Previously underwent surgical and interventional shunt procedures;
- Presence of contraindications to endoscopic or interventional treatment; ⑥ Extensive portal vein thrombosis, cavernous transformation of the portal vein;
- ⑦ Massive ascites;
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- ⑧ Concurrent advanced liver cancer or other malignant tumors with a predicted lifespan of less than 3 months;
- ⑨ Concurrent severe diseases of other organs such as the heart, lungs, and kidneys;
- ⑩ Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Contrast Endoscopic Ultrasound-Guided Tissue Glue/Coil Devascularization vs. Balloon-Occluded Retrograde Transvenous Obliteration for Preventing Recurrent Gastric Variceal Bleeding: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are:
Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment?
Read more
Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications.
Participants will:
Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.
- Conditions
- Gastric Varices Bleeding
- Being tested
- EUS-guided tissue glue/coil injection, BRTO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided tissue glue/coil injectionProcedure or surgery
Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.
BRTOProcedure or surgery
Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided tissue glue/coil injection arm | Experimental | Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure. Receives: Procedure: EUS-guided tissue glue/coil injection |
| BRTO arm | Active comparator | Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure. Receives: Procedure: BRTO |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year all-cause rebleeding rate
The rate of upper gastrointestinal bleeding occurring within one year after the operation, regardless of the cause
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Varices BleedingStudies of the same condition, open and under way.
- More trials run by West China 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Jinlin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049146
- Sponsor's protocol ID
- 2025 Audit No. 670
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Contrast Endoscopic Ultrasound-Guided Tissue Glue/Coil Devascularization vs. Balloon-Occluded Retrograde Transvenous Obliteration for Preventing Recurrent Gastric Variceal Bleeding: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07049146
- Acronym / sponsor ID
- 2025 Audit No. 670
- Conditions
- Gastric Varices Bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Jul 2025 (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 goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are:
Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment?
Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications.
Participants will:
Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided tissue glue/coil injection arm | Experimental | Procedure: EUS-guided tissue glue/coil injectionUnder linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure. |
| BRTO arm | Active comparator | Procedure: BRTOEstablish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years old;
Key exclusion criteria (9 listed)
- Previously received vascular interventional therapy for preventing rebleeding of GVs;
- ⑦ Massive ascites;
- ⑧ Concurrent advanced liver cancer or other malignant tumors with a predicted lifespan of less than 3 months;
- ⑨ Concurrent severe diseases of other organs such as the heart, lungs, and kidneys;
- ⑩ Pregnant or lactating women.
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 tissue glue/coil injectionUnder linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure. | Procedure or surgery | EUS-guided tissue glue/coil injection arm |
| BRTOEstablish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure. | Procedure or surgery | BRTO arm |
Primary outcome
One-year all-cause rebleeding rate
Time frame: one year
The rate of upper gastrointestinal bleeding occurring within one year after the operation, regardless of the cause
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 3 Jul 2025.
- 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 tissue glue/coil injection and BRTO in people with Gastric Varices Bleeding, run by West China Hospital at 1 site in China.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Jul 2025. 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 China. 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 Jinlin Yang (+86 18980602058, yangjinlin@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year all-cause rebleeding rate (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.