RecruitingNot ApplicableNCT05629845

Prevention of Variceal Rebleeding by EUS-guided vs Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients

Secondary Prevention of Variceal Rebleeding by Endoscopic Ultrasound-guided Therapy Versus Conventional Endoscopic Therapy in Hepatocellular Carcinoma Patients: a Randomized Controlled Trial


Sponsor

Chinese University of Hong Kong

Enrollment

84 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods for preventing re-bleeding from varicose veins in the esophagus or stomach (called varices) in patients with liver cancer (hepatocellular carcinoma). One approach uses conventional endoscopy (rubber band ligation or glue injection), and the other uses an ultrasound-guided endoscopic technique (EUS-guided therapy) that can target veins more precisely. **You may be eligible if...** - You have liver cancer (HCC) and recently had a variceal bleed (esophageal or gastric varices) that was successfully stopped by conventional endoscopy - The bleeding episode was within the past 4 weeks - You are able to provide written informed consent **You may NOT be eligible if...** - You are unable to give informed consent - You have health conditions that make any endoscopy unsafe - Your bleeding was not from varices - You have severe, uncorrectable blood clotting problems (INR above 1.5 or very low platelets despite transfusions) - You are in the terminal stage of illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendoscopic ultrasound-guided therapy

EUS-guided glue injection will be used for secondary prevention of EV or GV rebleeding.

PROCEDUREconventional endoscopic therapy

conventional endoscopic therapy (VBL for EV or glue injection for GV) for secondary prevention of EV or GV rebleeding.


Locations(1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

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NCT05629845


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