Primary Prophylaxis of Esophageal Varices in Patients Treated With Atezolizumab and Bevacizumab for Advanced Hepatocellular Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- esophagogastric varices progression rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HCC patients with small non-risky EGVs
55 patients with small EGVs that had no red signs undergoing variceal band ligation.
干预措施: Esophageal band ligation (Procedure)
HCC patients with no or small non-risky EGVs
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.
结局指标
主要结局
esophagogastric varices progression rate
时间窗: 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
时间窗: 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.
次要结局
- shortening the endoscopic follow-up intervals(through study completion, an average of 1 year)
研究者
Rania Mamdouh Elkafoury
Lecturer of Tropical Medicine
Tanta University