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NCT05629845
Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients
Conditions: Hepatocellular Carcinoma, Variceal Bleeding
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 84
Sponsor: Chinese University of Hong Kong
Location: Hong Kong
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 proceduresExclusion Criteria:Unable to provide written informed consentContraindications for endoscopy due to underlying comorbiditiesHCC patients with non-variceal source of gastrointestinal bleedingRefractory coagulopathy (INR>1.5)
or refractory thrombocytopenia (platelets <50,000) despite blood product transfusionMoribund patients from terminal illness
Source: ClinicalTrials.gov (NCT05629845). StuddyBuddy aggregates publicly available trial information.