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EUS Glue vs Endoscopic Variceal Band Ligation for Prevention of Rebleeding in Patients With HCC and EV Bleeding: a Retrospective Comparative Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04918459
Acronym
EUSgluevsVBL
Enrollment
70
Registered
2021-06-08
Start date
2021-08-06
Completion date
2026-12-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Variceal Band Ligation, Esophageal Variceal Bleeding, EUS Guided Cyanoacrylate Injection, Hepatocelular Carcinoma

Brief 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

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.

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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 2. Age \> 18 years

Exclusion criteria

1. HCC patients with non-variceal upper GI bleeding 2. HCC patients with history of EV bleeding who did not undergo further endoscopy for secondary prophylaxis for EV rebleeding

Design outcomes

Primary

MeasureTime frameDescription
Death adjusted cumulative incidence of rebleeding at 30-day30 daysDeath adjusted cumulative incidence of rebleeding at 30-day

Secondary

MeasureTime frameDescription
Death adjusted cumulative incidence of rebleeding at 90-day90 daysDeath adjusted cumulative incidence of rebleeding at 90-day
Bleeding-free survival at 3 months and 6 months6 monthsBleeding-free survival at 3 months and 6 months
Adverse events related to EUS-CYA or EGD-VBL for secondary prophylaxisduring EUS procedureAdverse events related to EUS-CYA or EGD-VBL for secondary prophylaxis
Mortality rate at 6 months6 monthsMortality rate at 6 months

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORRaymond Tang

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026