NCT05629845 Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients
| NCT ID | NCT05629845 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2022-11-22 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rebleeding rate is high in hepatocellular carcinoma (HCC) patients with variceal bleeding despite conventional endoscopic therapies for esophageal and gastric varices (EV, GV). Secondary prevention of variceal rebleeding was reported to improve outcomes of HCC patients, but the optimal endoscopic approach is not well defined. In this difficult-to-manage population, variceal rebleeding rates remain substantial after conventional endoscopic therapies. n recent studies by others and our group on direct EUS-guided therapy for varices in cirrhotic patients, high technical success (90 - 100%), low post-treatment rebleeding rate (3 - 11%) and low adverse event rate (\~3%) have been reported for GV treatment by cyanoacrylate glue injection, coiling or a combination of both, and for cyanoacrylate glue injection or coiling of EV refractory to variceal band ligation (VBL). This study aims to compare rebleeding rates after secondary prevention by EUS-guided therapy or conventional endoscopic therapy in HCC patients with recent variceal bleeding.
Eligibility Criteria
Inclusion Criteria: * Consecutive HCC patients age 18 or older with recent (within 4 weeks of the episode) EV or GV bleeding successfully controlled by conventional endoscopic therapies (VBL for EV or glue injection for GV) * Able to provide written informed consent to participate in the study and comply with the study procedures Exclusion Criteria: * Unable to provide written informed consent * Contraindications for endoscopy due to underlying comorbidities * HCC patients with non-variceal source of gastrointestinal bleeding * Refractory coagulopathy (INR\>1.5) or refractory thrombocytopenia (platelets \<50,000) despite blood product transfusion * Moribund patients from terminal illness
Contact & Investigator
Raymond S Tang, MD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05629845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05629845 currently recruiting?
Yes, NCT05629845 is actively recruiting participants. Contact the research team at raymondtang@cuhk.edu.hk for enrollment information.
Where is the NCT05629845 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT05629845 clinical trial?
NCT05629845 is sponsored by Chinese University of Hong Kong. The principal investigator is Raymond S Tang, MD at Chinese University of Hong Kong. The trial plans to enroll 84 participants.
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