Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab

Tanta University

Status: Enrolling

Conditions: Esophageal and/or Gastric Varices; Hepatocellular Carcinoma (HCC)

Treatments: Procedure: Esophageal band ligation

Study type: Interventional

Funder types: Other

Identifiers

NCT06961526

36264PR1125/3/25

Details and patient eligibility

About

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).

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

HCC patients with small non-risky EGVs

Active Comparator group

Description:

55 patients with small EGVs that had no red signs undergoing variceal band ligation.

Treatment:

Procedure: Esophageal band ligation

HCC patients with no or small non-risky EGVs

No Intervention group

Description:

55 patients with no or small EGVs that had no red signs. patients will be followed up after 3, 6, 9, 12 months of atezolizumab-bevacizumab therapy.