Esophageal Varices Prophylaxis in Hepatocellular Carcinoma Treated With Atezolizumab and Bevacizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esophageal band ligation.
- Who it may be relevant to
- Registry conditions: Esophageal and/or Gastric Varices, Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.
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).
Interventions
- Procedure Esophageal band ligation
upper endoscopy will be performed within 6 months before starting atezolizumab-bevacizumab therapy in HCC patients. Esophageal band ligation for small non-risky varices before starting atezolizumab-bevacizumab therapy. Endoscopy will be repeated 3, 5, 9, 12 months after atezolizumab-bevacizumab therapy
Primary outcome measures
- esophagogastric varices progression rate [Time frame: through study completion, an average of 1 year]
- variceal band ligation in small varices without bleeding stigmata [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- shortening the endoscopic follow-up intervals [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT06961526 · 36264PR1125/3/25