Esophageal and/or Gastric Varices, Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Esophageal varices, hepatocellular carcinoma, atezolizumab-bevacizumab therapy
Brief summary
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
PROCEDUREEsophageal 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
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| esophagogastric varices progression rate | through study completion, an average of 1 year | evaluating esophagogastric varices progression rate at 3, 5, 9, and 12 months of starting atezolizumab-bevacizumab therapy. |
| variceal band ligation in small varices without bleeding stigmata | through study completion, an average of 1 year | Evaluating the effect of variceal band ligation in small varices without bleeding stigmata in reducing the variceal bleeding rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| shortening the endoscopic follow-up intervals | through study completion, an average of 1 year | Evaluating the effect of shortening the endoscopic follow-up intervals to reduce the variceal bleeding rate in patients treated with atezolizumab-bevacizumab therapy. |
Countries
Egypt
Contacts
Primary ContactRania M Elkafoury, MD
Backup ContactNabila A Elgazzar, MD
Outcome results
None listed