息肉切除术后结肠镜检查间隔与结直肠癌发病率。
完整摘要 · 中文译文
背景：需要更多证据为息肉切除术后结肠镜监测间隔的建议提供依据。方法：在这项正在进行的、在八个欧洲国家开展的非劣效性试验中，我们将高危腺瘤患者（定义为≥1个腺瘤直径≥10 mm，或高级别异型增生，或绒毛状生长，或3至10个任何类型的腺瘤）随机分配在息肉切除术后5年或3年时接受首次结肠镜检查；目前指南推荐3年监测。3年组也在5年时接受结肠镜检查。主要终点是10年时结直肠癌的累积发生率，预设非劣效界值为两组差异置信区间上界的0.7个百分点。此处，我们报告随访5.5年后进行的中期分析结果。采用逆概率加权处理因未参与5年监测结肠镜检查而导致的数据缺失。在此分析中，结直肠癌发生率以单侧99.12%置信区间报告；对于10年时的最终分析，计划计算95.33%置信区间，以维持总体I类错误率为5%。 结果：共有10,799名患者接受了随机分组：5398名患者被分配到5年组，5401名被分配到3年组。在较低频度监测组中，结直肠癌的5年累积发病率为0.77%，在较高频度监测组中为0.82%（差异为-0.05个百分点）；99.12%可信区间的上界为0.68，符合非劣效性标准。两组在诊断时的癌症分期分布似乎没有实质性差异。共有5名患者死于结直肠癌：5年组3名（0.06%），3年组2名（0.04%）。 结论：在这项为期10年的非劣效性试验的中期分析中，对于高危腺瘤患者，息肉切除术后5年开始监测性结肠镜检查在5年结直肠癌累积发病率方面不劣于3年开始监测。（由挪威研究理事会及其他机构资助；EPoS II ClinicalTrials.gov编号：NCT02319928。）
完整摘要 · 英文原文
BACKGROUND: More evidence is needed to inform recommendations for intervals of colonoscopy surveillance after polyp removal. METHODS: In this ongoing noninferiority trial conducted in eight European countries, we randomly assigned patients with high-risk adenomas (defined as ≥1 adenoma with a diameter of ≥10 mm, high-grade dysplasia, or villous growth or 3 to 10 adenomas of any kind) to undergo a first colonoscopy at 5 years after polyp removal or at 3 years; surveillance at 3 years is currently recommended in guidelines. The 3-year group also underwent colonoscopy at 5 years. The primary end point is the cumulative incidence of colorectal cancer at 10 years, with a prespecified noninferiority margin of 0.7 percentage points for the upper boundary of the confidence interval for the difference between the two groups. Here, we report the results of an interim analysis conducted after 5.5 years of follow-up. Inverse probability weighting was used to account for missing data owing to nonparticipation in surveillance colonoscopy at 5 years. In this analysis, the incidence of colorectal cancer is reported with a one-sided 99.12% confidence interval; for the final analysis at 10 years, the plan is to calculate a 95.33% confidence interval to maintain an overall type I error of 5%. RESULTS: A total of 10,799 patients underwent randomization: 5398 patients were assigned to the 5-year group and 5401 to the 3-year group. The 5-year cumulative incidence of colorectal cancer was 0.77% with less-frequent surveillance and 0.82% with more-frequent surveillance (difference, -0.05 percentage points); the upper boundary of the 99.12% confidence interval was 0.68, which met the criterion for noninferiority. The distribution of cancer stage at diagnosis did not appear to differ substantially between the two groups. A total of 5 patients died of colorectal cancer: 3 patients (0.06%) in the 5-year group and 2 (0.04%) in the 3-year group. CONCLUSIONS: In this interim analysis of a 10-year noninferiority trial, beginning surveillance colonoscopy at 5 years after polyp removal was noninferior to beginning at 3 years with respect to the cumulative incidence of colorectal cancer at 5 years among patients with high-risk adenomas. (Funded by the Research Council of Norway and others; EPoS II ClinicalTrials.gov number, NCT02319928.).