EUS Guided Cyanoacrylate InjectionEUSgluevsVBLNCT04918459
EUS Glue vs Endoscopic Variceal Band Ligation for Prevention of Rebleeding in Patients With HCC and EV Bleeding: a Retrospective Comparative Study
An observational study of EUS Guided Cyanoacrylate Injection and Endoscopic Variceal Band Ligation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
SP by EUS-CYA improves clinical outcomes (eg, EV rebleeding) in patients with HCC and prior EV bleeding when compared with SP by EGD-VBL Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EUS Guided Cyanoacrylate Injection, Endoscopic Variceal Band Ligation, Hepatocelular Carcinoma
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Aug 2021to 30 Dec 2026
- Phase
- Observational
- 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
Study population: HCC apatients
Who may be able to join
- Consecutive HCC patients with history of EV bleeding who underwent EUS guided cyanoacrylate injection or variceal band ligation by EGD for secondary prophylaxis to prevent EV rebleeding
- Age > 18 years
Who cannot join
- HCC patients with non-variceal upper GI bleeding
- HCC patients with history of EV bleeding who did not undergo further endoscopy for secondary prophylaxis for EV rebleeding
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Prince of Wales Hospital, The Chinese University of Hong Kong
Shatin, New Territories
About this study
Official title: EUS Guided Cyanoacrylate Injection vs Endoscopic Variceal Band Ligation for Prevention of Rebleeding in Patients With Hepatocellular Carcinoma and Esophageal Variceal Bleeding: a Retrospective Comparative Study
SP by EUS-CYA improves clinical outcomes (eg, EV rebleeding) in patients with HCC and prior EV bleeding when compared with SP by EGD-VBL
Read the detailed description
Variceal bleeding is a life-threatening complication in patients with portal hypertension and cirrhosis. Rebleeding is common in patients who survive the acute variceal bleeding episode without secondary prophylaxis (SP). Hepatocellular carcinoma (HCC) and portal vein thrombosis (PVT) are associated with recurrent variceal bleeding and worse clinical outcomes. Rebleeding rates of esophageal varices (EV) and gastric varices (GV) remain substantial in HCC patients despite conventional endoscopic treatments.
Lack of SP was associated with a higher rate of rebleeding and mortality in a multicenter study of HCC patients with prior EV bleeding. SP of variceal rebleeding in suitable HCC patients has been suggested in the latest practice guideline of the American Association for the Study of Liver Diseases, but the optimal endoscopic approach for SP in HCC patients has not been well defined. Whether conventional strategies such as variceal band ligation (VBL) or cyanoacrylate (CYA) injection for EV can achieve durable variceal control in HCC patients remains unclear since HCC patients were often excluded from clinical trials. This remains a pertinent issue as recent advances in the treatment of advanced HCC with tyrosine kinase inhibitors (TKI) and immunotherapy means that some patients may achieve reasonable survival and benefit from further variceal management.
Recently, endoscopic ultrasound (EUS) guided variceal interventions by CYA, coiling, or a combination of both have gained clinical attention due to its high clinical success. When compared with conventional endoscopic variceal treatments, EUS guided variceal interventions allow real-time confirmation of intra-variceal delivery of therapy and flow obliteration after treatment. A recent study from our group reported that SP by EUS-CYA reduced rebleeding rate and improved variceal bleeding-free survival in patients with inoperable HCC and variceal bleeding when compared with no SP. However, there has been no dedicated study comparing the clinical outcomes of SP by EUS guided CYA (EUS-CYA) or conventional VBL by esophagogastroduodenoscopy (EGD) in patients with HCC and EV bleeding. Therefore, we propose this retrospective study to compare the clinical outcomes after EUS-CYA or EGD-VBL for SP of EV rebleeding in this often difficult-to-treat patient group with HCC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EUS guided cyanoacrylate injection | EUS guided cyanoacrylate injection to prevent EV rebleeding. | |
| variceal band ligation | variceal band ligation to prevent EV rebleeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death adjusted cumulative incidence of rebleeding at 30-day
Death adjusted cumulative incidence of rebleeding at 30-day
Measured: 30 days
Secondary outcomes (4)
Death adjusted cumulative incidence of rebleeding at 90-day
Death adjusted cumulative incidence of rebleeding at 90-day
Measured: 90 days
Bleeding-free survival at 3 months and 6 months
Bleeding-free survival at 3 months and 6 months
Measured: 6 months
Adverse events related to EUS-CYA or EGD-VBL for secondary prophylaxis
Adverse events related to EUS-CYA or EGD-VBL for secondary prophylaxis
Measured: during EUS procedure
Mortality rate at 6 months
Mortality rate at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start6 Aug 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EUS Guided Cyanoacrylate InjectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Shing Yan Tang, Chinese University of Hong Kong
- Investigators
- Raymond Tang, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918459
- Sponsor's protocol ID
- 2021.221
- Acronym
- EUSgluevsVBL
- Status last verified
- Mar 2026
- First submitted
- 3 Jun 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Guided Cyanoacrylate Injection vs Endoscopic Variceal Band Ligation for Prevention of Rebleeding in Patients With Hepatocellular Carcinoma and Esophageal Variceal Bleeding: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT04918459
- Acronym / sponsor ID
- EUSgluevsVBL / 2021.221
- Conditions
- EUS Guided Cyanoacrylate Injection, Endoscopic Variceal Band Ligation, Hepatocelular Carcinoma, Esophageal Variceal Bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jun 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.
SP by EUS-CYA improves clinical outcomes (eg, EV rebleeding) in patients with HCC and prior EV bleeding when compared with SP by EGD-VBL
Detailed description
Variceal bleeding is a life-threatening complication in patients with portal hypertension and cirrhosis. Rebleeding is common in patients who survive the acute variceal bleeding episode without secondary prophylaxis (SP). Hepatocellular carcinoma (HCC) and portal vein thrombosis (PVT) are associated with recurrent variceal bleeding and worse clinical outcomes. Rebleeding rates of esophageal varices (EV) and gastric varices (GV) remain substantial in HCC patients despite conventional endoscopic treatments.
Lack of SP was associated with a higher rate of rebleeding and mortality in a multicenter study of HCC patients with prior EV bleeding. SP of variceal rebleeding in suitable HCC patients has been suggested in the latest practice guideline of the American Association for the Study of Liver Diseases, but the optimal endoscopic approach for SP in HCC patients has not been well defined. Whether conventional strategies such as variceal band ligation (VBL) or cyanoacrylate (CYA) injection for EV can achieve durable variceal control in HCC patients remains unclear since HCC patients were often excluded from clinical trials. This remains a pertinent issue as recent advances in the treatment of advanced HCC with tyrosine kinase inhibitors (TKI) and immunotherapy means that some patients may achieve reasonable survival and benefit from further variceal management.
Recently, endoscopic ultrasound (EUS) guided variceal interventions by CYA, coiling, or a combination of both have gained clinical attention due to its high clinical success. When compared with conventional endoscopic variceal treatments, EUS guided variceal interventions allow real-time confirmation of intra-variceal delivery of therapy and flow obliteration after treatment. A recent study from our group reported that SP by EUS-CYA reduced rebleeding rate and improved variceal bleeding-free survival in patients with inoperable HCC and variceal bleeding when compared with no SP. However, there has been no dedicated study comparing the clinical outcomes of SP by EUS guided CYA (EUS-CYA) or conventional VBL by esophagogastroduodenoscopy (EGD) in patients with HCC and EV bleeding. Therefore, we propose this retrospective study to compare the clinical outcomes after EUS-CYA or EGD-VBL for SP of EV rebleeding in this often difficult-to-treat patient group with HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS guided cyanoacrylate injection | – | –EUS guided cyanoacrylate injection to prevent EV rebleeding. |
| variceal band ligation | – | –variceal band ligation to prevent EV rebleeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC apatients
Key inclusion criteria (2 listed)
- Consecutive HCC patients with history of EV bleeding who underwent EUS guided cyanoacrylate injection or variceal band ligation by EGD for secondary prophylaxis to prevent EV rebleeding
- Age > 18 years
Key exclusion criteria (2 listed)
- HCC patients with non-variceal upper GI bleeding
- HCC patients with history of EV bleeding who did not undergo further endoscopy for secondary prophylaxis for EV rebleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death adjusted cumulative incidence of rebleeding at 30-day
Time frame: 30 days
Death adjusted cumulative incidence of rebleeding at 30-day
4 secondary outcomes
Death adjusted cumulative incidence of rebleeding at 90-day
Time frame: 90 days
Bleeding-free survival at 3 months and 6 months
Time frame: 6 months
Adverse events related to EUS-CYA or EGD-VBL for secondary prophylaxis
Time frame: during EUS procedure
Mortality rate at 6 months
Time frame: 6 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 19 Mar 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Raymond Tang principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EUS Guided Cyanoacrylate Injection and Endoscopic Variceal Band Ligation, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death adjusted cumulative incidence of rebleeding at 30-day (time frame: 30 days). 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 19 Mar 2026.