Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients
Recruiting now · Not applicable
Conditions studied: Hepatocellular Carcinoma, Variceal Bleeding
In brief
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.
Key facts
- Study ID
- NCT05629845
- Run by
- Chinese University of Hong Kong
- People needed
- 84
- Starts
- 2022-11-22
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Prince of Wales Hospital, The Chinese University of Hong Kong — Shatin, New Territories, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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