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

NCT06594744 | Recruiting Phase 4

• 1 other identifier: 2024-02-016B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma (HCC); Esophageal Varices

Keywords

Endoscopic variceal ligation; Hepatocellular carcinoma; Nonselective beta-blocker; Portal hypertension

Outcome Measures

Primary Outcomes (1)

• Esophageal variceal bleeding

  The cumulative incidence of esophageal variceal bleeding

  3 years

Secondary Outcomes (4)

• Other upper gastrointestinal bleeding

  3 years

• First/further nonbleeding liver decompensation

  3 years

• Overall survival

  3 years

• Adverse events

  3 years

Other Outcomes (1)

• Primary and secondary outcomes categorized by BCLC staging in the subgroup analysis

  3 years

Study Arms (2)

Endoscopic variceal ligation

ACTIVE COMPARATOR

EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically.

Procedure: Endoscopic variceal ligation

Carvedilol

PLACEBO COMPARATOR

The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \< 90 mmHg), bradycardia (resting heart rate \< 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.

Drug: Carvedilol

Interventions

Endoscopic variceal ligation PROCEDURE

EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically.

Endoscopic variceal ligation

Carvedilol DRUG

The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \&lt; 90 mmHg), bradycardia (resting heart rate \&lt; 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.

Carvedilol

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Esophageal and Gastric Varices; Hypertension, Portal

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Tsung-Chieh Yang, MD

CONTACT

+886-2-28712121; tcyang@vghtpe.gov.tw

Ming-Chih Hou, MD

CONTACT

+886-2-28712121; mchou@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: EVL group: EVL will be performed and repeated every 3 to 4 weeks until the EVs are eradicated. Following this, patients will undergo regular upper gastrointestinal endoscopic surveillance, initially every three months for a total of two sessions, then every six months for a total of two sessions, and subsequently annually. If EVs are found to recur during surveillance, additional EVL will be performed every 3 to 4 weeks until the varices are again eradicated endoscopically. Carvedilol group: The initial dosage of carvedilol is set at 6.25 mg daily. In the absence of hypotension (systolic blood pressure \&amp;amp;lt; 90 mmHg), bradycardia (resting heart rate \&amp;amp;lt; 55 beats per minute), or other adverse effects, hospitalized patients may have their dosage increased to 12.5 mg daily after 3 days, while outpatient patients may increase their dosage to 12.5 mg daily after 7 days. This dosage represents the target dose for the trial.

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)