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.
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
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
Parallel
endoscopic ultrasound-guided therapy
Procedure/SurgeryEUS-guided glue injection will be used for secondary prevention of EV or GV rebleeding.
conventional endoscopic therapy
Procedure/Surgeryconventional endoscopic therapy (VBL for EV or glue injection for GV) for secondary prevention of EV or GV rebleeding.
90-day death adjusted cumulative incidence of variceal rebleeding after secondary prevention by EUS-guided therapy or conventional endoscopic therapy
Cumulative incidence of variceal rebleeding at 90-day after study procedures will be analyzed after adjustment of incidence of death from HCC or cirrhosis
30-day death adjusted cumulative incidence of variceal rebleeding after secondary prevention by EUS-guided therapy or conventional endoscopic therapy
Cumulative incidence of variceal rebleeding at 30-day after study procedures will be analyzed after adjustment of incidence of death from HCC or cirrhosis
bleeding-free survival at 3 months after secondary prevention by EUS-guided therapy or conventional endoscopic therapy
To determine the proportion of patients who do not have rebleeding and are alive at 3 months after study procedures
procedure related adverse events within 30 days of secondary prevention
procedure related adverse events are defined as perforation, glue-lipiodol embolization, post-banding ulcer bleeding, infection, death related to procedure
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