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

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

Study Overview

• Status: Active, not recruiting
• Conditions: EUS Guided Cyanoacrylate Injection; Endoscopic Variceal Band Ligation; Hepatocelular Carcinoma; Esophageal Variceal Bleeding

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Prince of Wales Hospital, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HCC apatients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EUS guided cyanoacrylate injection; EUS guided cyanoacrylate injection to prevent EV rebleeding.
variceal band ligation; variceal band ligation to prevent EV rebleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death adjusted cumulative incidence of rebleeding at 30-day	Death adjusted cumulative incidence of rebleeding at 30-day	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death adjusted cumulative incidence of rebleeding at 90-day	Death adjusted cumulative incidence of rebleeding at 90-day	90 days
Bleeding-free survival at 3 months and 6 months	Bleeding-free survival at 3 months and 6 months	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	during EUS procedure
Mortality rate at 6 months	Mortality rate at 6 months	6 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Raymond Tang, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Hemorrhage
• Other Study ID Numbers: 2021.221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No