Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC

Recruiting · NCT06594744 · Interventional (participants receive a specific treatment) · Lead sponsor: Taipei Veterans General Hospital, Taiwan

View the official record on ClinicalTrials.gov →

Hypertension

Interventions studied

CarvedilolEndoscopic variceal ligation

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.

Who can take part

Age range

20 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 4

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

\- Patients with HCC and high-risk EVs, confirmed through imaging and clinical data (classified as F2 or F3 EVs according to Beppu et al. classification)

Exclusion criteria

Age less than 20 years or greater than 90 years.
History of esophageal variceal bleeding.
Previous treatment for EVs, including EVL, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt (TIPS), or surgical interventions.
Use of non-selective β-blockers within two weeks prior to enrollment.
Contraindications for non-selective β-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, poorly controlled diabetes, and severe peripheral artery disease.
Presence of other end-stage organ diseases, including terminal cancers other than HCC, heart failure, and renal failure.
Pregnant women.

Where it is running

1 location listed.

Taipei Veterans General Hospital - Taipei, Taiwan

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →