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Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this prospective cohort study is to evaluate the progression of esophagogastric varices in patients treated with atezolizumab-bevacizumab. Assess the efficacy of primary prophylaxis of small esophageal varices with no risky signs and shortening endoscopic follow-up time intervals to reduce the risk of variceal hemorrhage.

Researchers will assess the progression of esophageal varices (EVs) with no bleeding stigmata in patients treated with atezolizumab-bevacizumab therapy at 3, 6, 9, and 12 months with endoscopic examination. Evaluate the effect of shortening the endoscopic follow-up intervals to reduce the risk of variceal bleeding in patients treated with atezolizumab-bevacizumab therapy. Researchers will also assess the efficacy of variceal band ligation in small varices without bleeding stigmata before starting atezolizumab-bevacizumab therapy to reduce the progression of EVs.

Participants will undergo history-taking, clinical examination, laboratory investigations, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), abdominal ultrasonography, and upper endoscopy (within 6 months before beginning of systemic therapy and followed up after 3, 6, 9, and 12 months).

Eligibility

Inclusion Criteria:

  • Patients with confirmed advanced HCC (Diagnosed by two imaging modalities or liver biopsy) eligible for atezolizumab-bevacizumab therapy.
  • Patients with preserved liver function (compensated Child-Pugh A if there is underlying cirrhosis).
  • Patients with performance status ≤2 at staging work-up.
  • Patients with no or grade 1 non-risky esophageal varices on pretreatment endoscopic examination.

Exclusion Criteria:

  • Child-Pugh class C patients.
  • Patients with performance status >2 at staging work-up.
  • Vascular disorders and arterial hypertension.
  • Severe autoimmune disorders.
  • Patients who lost follow-up.
  • Pregnant or breastfeeding women.
  • Unwilling to participate in our study.

Study details
    Esophageal and/or Gastric Varices
    Hepatocellular Carcinoma (HCC)

NCT06961526

Tanta University

23 May 2025

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