Background The value of hepatocellular carcinoma (HCC) screening is defined by the balance of benefits from early tumor detection vs harms due to false positive results. We evaluated the value of a mailed outreach strategy for HCC screening in patients with cirrhosis. Methods We conducted a multi-center pragmatic randomized clinical trial comparing mailed outreach for HCC screening (n = 1436) and usual care with visit-based screening (n = 1436) among patients with cirrhosis at three health systems from March 2018 to September 2021. Outcomes of interest were early-stage HCC detection (ie, screening benefit) and diagnostic evaluation for false positive or indeterminate results (ie, screening harm). Screening harm was categorized as mild, moderate, and severe based on number and type of diagnostic exams. All patients were included in intention-to-screen analyses. Results Of 125 patients diagnosed with HCC (67 outreach and 58 usual care), 71.2% were found at an early stage per the Milan Criteria. Early tumor detection did not significantly differ between the outreach and usual care arms (64.2% vs 79.3%, p = .06). The proportion of patients with physical harms also did not differ between the outreach and usual care arms (10.8% vs 10.7%, p = .95) with 5.9% in both arms having mild harms, 4.0% and 3.8% respectively with moderate harms, and 0.9% and 1.0% respectively with severe harms. Conclusion Most patients enrolled in HCC screening were detected at an early stage, and a minority experienced physical harms. A mailed outreach strategy did not significantly increase early HCC detection or physical harms compared to usual care. Clinical Trials number NCT02582918 and NCT03756051

中文翻译：

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肝硬化患者肝细胞癌筛查的益处和危害：多中心随机临床试验


背景 肝细胞癌 (HCC) 筛查的价值取决于早期肿瘤检测的益处与假阳性结果造成的危害之间的平衡。我们评估了针对肝硬化患者进行 HCC 筛查的邮寄外展策略的价值。方法 我们开展了一项多中心务实随机临床试验，比较了 2018 年 3 月至 2021 年 9 月在三个卫生系统的肝硬化患者中进行 HCC 筛查 (n = 1436) 的邮寄外展服务和常规护理与就诊筛查 (n = 1436) 的情况。感兴趣的结果是早期 HCC 检测（即筛查益处）和对假阳性或不确定结果的诊断评估（即筛查危害）。根据诊断检查的数量和类型，筛查危害被分为轻度、中度和重度。所有患者均纳入意向筛选分析。结果 根据米兰标准，在 125 名诊断为 HCC 的患者中（67 名外展患者和 58 名常规护理患者），71.2% 是在早期发现的。外展组和常规护理组之间的早期肿瘤检测没有显着差异（64.2% vs 79.3%，p = 0.06）。外展治疗组和常规护理组之间遭受身体伤害的患者比例也没有差异（10.8% vs 10.7%，p = .95），两个治疗组中分别有 5.9% 的患者遭受轻度伤害，4.0% 和 3.8% 的患者遭受中度伤害，危害严重的分别为0.9%和1.0%。结论 参加HCC筛查的患者大多数在早期就被发现，少数患者遭受了身体伤害。与常规护理相比，邮寄外展策略并未显着增加早期 HCC 检测或身体伤害。临床试验编号 NCT02582918 和 NCT03756051