AASLD Practice Guidance on risk stratification and management of portal hypertension and varices in cirrhosis.
David E Kaplan, Cristina Ripoll, Maja Thiele...
https://pubmed.ncbi.nlm.nih.gov/37870298Actively Recruiting
Phase 4
Age: 20Years - 90Years
All Genders
ID06594744
A Randomized Controlled Trial of Endoscopic Variceal Ligation Versus Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With Hepatocellular Carcinoma
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-02-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two methods to prevent the first esophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC) who have high-risk esophageal varices (EVs). The study evaluates the effectiveness and safety of endoscopic variceal ligation (EVL) versus carvedilol, a medication, in reducing the risk of EVB in this patient group. It also investigates medical problems participants may experience during treatment and compares outcomes such as bleeding, liver complications, overall survival, and side effects. Participants will be randomly assigned to one of two groups. One group will undergo EVL, a procedure performed every 3 to 4 weeks until varices are eradicated, followed by regular endoscopic surveillance initially every three months, then every six months, and finally annually. The other group will take carvedilol daily, starting at 6.25 mg and increasing to 12.5 mg if tolerated, with dosing adjustments depending on blood pressure and heart rate. This open-label trial monitors both treatment approaches over time. During the study, participants will visit the clinic every 2 to 3 months for checkups and tests. They will keep a diary recording vital signs such as blood pressure and heart rate, along with any symptoms. Researchers will measure the occurrence of esophageal variceal bleeding over three years, as well as other gastrointestinal bleeding, liver complications, survival, and adverse events. The study includes ongoing safety monitoring and assessments throughout the trial period.
CONDITIONS
Brief Title
Endoscopic Variceal Ligation vs Carvedilol for the Prevention of First Esophageal Variceal Bleeding in Patients With HCC
Who Can Participate
Age: 20Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma (HCC) and high-risk esophageal varices (EVs) confirmed by imaging and clinical data (classified as F2 or F3 EVs)
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 EVL, endoscopic sclerotherapy, TIPS, or surgery
- Use of non-selective beta-blockers within two weeks before enrollment
- Contraindications for non-selective beta-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, such as terminal cancers other than HCC, heart failure, and renal failure
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 years
Participants receive either endoscopic variceal ligation (EVL) repeated every 3 to 4 weeks until esophageal varices are eradicated, or carvedilol medication starting at 6.25 mg daily with possible dose increase to 12.5 mg daily. The treatment aims to prevent first esophageal variceal bleeding.
Repeated visits every 3 to 4 weeks during EVL treatment or regular medication monitoring visits
Follow-up
Duration - Up to 3 years
After initial treatment, participants undergo upper gastrointestinal endoscopic surveillance with visits initially every three months for two sessions, then every six months for two sessions, and subsequently annually. Additional EVL may be performed if varices recur.
Approximately 6 post-treatment visits over 3 years
Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
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Research Team
T
Tsung-Chieh Yang, MD
M
Ming-Chih Hou, MD
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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R N Pugh, I M Murray-Lyon, J L Dawson...
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S K Sarin, D Lahoti, S P Saxena...
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K Beppu, K Inokuchi, N Koyanagi...
https://pubmed.ncbi.nlm.nih.gov/6975734Nonselective beta blockers, hepatic decompensation, and mortality in cirrhosis: A national cohort study.
Marina Serper, David E Kaplan, Tamar H Taddei...
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https://pubmed.ncbi.nlm.nih.gov/38319892Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma.
Ann-Lii Cheng, Shukui Qin, Masafumi Ikeda...
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