NCT06594744 Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
| NCT ID | NCT06594744 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-10-01 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06594744 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06594744 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06594744 currently recruiting?
Yes, NCT06594744 is actively recruiting participants. Contact the research team at tcyang@vghtpe.gov.tw for enrollment information.
Where is the NCT06594744 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06594744 clinical trial?
NCT06594744 is sponsored by Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 120 participants.
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