Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Incidence of small hepatocellular carcinoma (HCC)
研究概览
简要总结
Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.
详细描述
Patients: All consecutive patients with compensated HBV, HCV, alcohol or hemochromatosis-related cirrhosis (without any previous clinical complication including liver cancer).
Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein assay (none versus 6-month).
End points: rate of small tumors (first main criteria); survival (second main criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Compensated cirrhosis
排除标准
- •Antecedent of osmic acid synoviorthesis or of isotopic synoviorthesis of the studied knee
- •Intra-articular injection of triamcinolone hexacetonide in three months preceding the inclusion or by a different corticoid in the month preceding the inclusion
- •Evolutionary infectious or neoplastic pathology
结局指标
主要结局
Incidence of small hepatocellular carcinoma (HCC)
时间窗: 6 months versus 3 months
次要结局
- Survival(during the study)
- Clinical value of serum alfa-fetoprotein assay(during the study)