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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-90
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Endoscopic variceal ligation
  • Carvedilol

Treatment groups

120 Participants
are divided into 2 treatment groups