Actively Recruiting
Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-02-13
120
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate whether endoscopic variceal ligation (EVL) or carvedilol is more effective at preventing the first esophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC). It will also learn about the safety of EVL and carvedilol in patients with HCC. The main questions it aims to answer are: Whether EVL or carvedilol is more effective at preventing initial EVB in patients with HCC with high-risk EVs. What medical problems do participants have when undergoing EVL or taking carvedilol? Researchers will compare the efficacy and safety of EVL to carvedilol for the prevention of first EVB in patients with HCC. Participants will: Undergo EVL every 3-4 weeks until variceal eradication and then receive regular endoscopic follow-up according to the protocol, or Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.
CONDITIONS
Official Title
Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma and high-risk esophageal varices confirmed by imaging and clinical data (classified as F2 or F3 according to Beppu et al. classification)
You will not qualify if you...
- Age less than 20 years or greater than 90 years
- History of esophageal variceal bleeding
- Previous treatment for esophageal varices including endoscopic variceal ligation, sclerotherapy, TIPS, or surgery
- Use of non-selective beta-blockers within two weeks prior to enrollment
- Contraindications for non-selective beta-blockers such as severe atrioventricular block, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, and severe peripheral artery disease
- Presence of other end-stage organ diseases including terminal cancers other than hepatocellular carcinoma, heart failure, and renal failure
- Pregnant women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
T
Tsung-Chieh Yang, MD
CONTACT
M
Ming-Chih Hou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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