重复粪便免疫化学试验与乙状结肠镜检查筛查结直肠癌：一项随机试验的基线结果。
Colorectal Cancer Screening With Repeated Fecal Immunochemical Test Versus Sigmoidoscopy: Baseline Results From a Randomized Trial.
机构信息
Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Research and Development, Telemark Hospital Trust, Skien, Norway; Institute of Health and Society, University of Oslo, Oslo, Norway.
Section for Colorectal Cancer Screening, Cancer Registry of Norway, Oslo, Norway; Department of Medicine, Vestre Viken Hospital Trust Bærum, Gjettum, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
出版信息
Gastroenterology. 2021 Mar;160(4):1085-1096.e5. doi: 10.1053/j.gastro.2020.11.037. Epub 2020 Nov 21.
BACKGROUND & AIMS: The comparative effectiveness of sigmoidoscopy and fecal immunochemical testing (FIT) for colorectal cancer (CRC) screening is unknown.
METHODS
Individuals aged 50-74 years living in Southeast Norway were randomly invited between 2012 and 2019 to either once-only flexible sigmoidoscopy or FIT screening every second year. Colonoscopy was recommended after sigmoidoscopy if any polyp of ≥10 mm, ≥3 adenomas, any advanced adenomas, or CRC was found or, subsequent to, FIT >15 μg hemoglobin/g feces. Data for this report were obtained after complete recruitment in both groups and included 2 full FIT rounds and part of the third round. Outcome measures were participation, neoplasia detection, and adverse events. Age-standardized detection rates and age-adjusted odds ratios (ORs) were calculated.
RESULTS
We included 139,291 individuals: 69,195 randomized to sigmoidoscopy and 70,096 to FIT. The participation rate was 52% for sigmoidoscopy, 58% in the first FIT round, and 68% for 3 cumulative FIT rounds. Compared to sigmoidoscopy, the detection rate for CRC was similar in the first FIT round (0.25% vs 0.27%; OR, 0.92; 95% confidence interval [CI], 0.75-1.13) but higher after 3 FIT rounds (0.49% vs 0.27%; OR, 1.87; 95% CI, 1.54-2.27). Advanced adenoma detection rate was lower in the first FIT round compared to sigmoidoscopy at 1.4% vs 2.4% (OR, 0.57; 95% CI, 0.53-0.62) but higher after 3 cumulative FIT rounds at 2.7% vs 2.4% (OR, 1.14; 95% CI, 1.05-1.23). There were 33 (0.05%) serious adverse events in the sigmoidoscopy group compared to 47 (0.07%) in the FIT group (P = .13).
CONCLUSIONS
Participation was higher and more CRC and advanced adenomas were detected with repeated FIT compared to sigmoidoscopy. The risk of perforation and bleeding was comparable. Clinicaltrials.gov, Number: NCT01538550.
背景与目的
乙状结肠镜检查和粪便免疫化学检测（FIT）在结直肠癌（CRC）筛查方面的比较效果尚不清楚。
方法
2012 年至 2019 年期间，居住在挪威东南部的 50-74 岁人群被随机邀请参加单次乙状结肠镜检查或每两年进行一次 FIT 筛查。如果发现任何>10mm 的息肉、≥3 个腺瘤、任何高级别腺瘤或 CRC，或者 FIT>15μg 血红蛋白/g 粪便，则推荐进行结肠镜检查。本报告的数据是在两组均完成招募后获得的，包括 2 次完整的 FIT 轮次和第 3 轮次的一部分。主要终点是参与率、肿瘤检出率和不良事件。计算了标准化检出率和年龄调整后的比值比（OR）。
结果
我们共纳入 139291 人：69195 人随机分配至乙状结肠镜组，70096 人分配至 FIT 组。乙状结肠镜组的参与率为 52%，第 1 轮 FIT 的参与率为 58%，3 轮 FIT 的累积参与率为 68%。与乙状结肠镜组相比，第 1 轮 FIT 的 CRC 检出率相似（0.25% vs 0.27%；OR，0.92；95%置信区间[CI]，0.75-1.13），但在 3 轮 FIT 后更高（0.49% vs 0.27%；OR，1.87；95%CI，1.54-2.27）。第 1 轮 FIT 的高级别腺瘤检出率低于乙状结肠镜组，分别为 1.4%和 2.4%（OR，0.57；95%CI，0.53-0.62），但在 3 轮 FIT 后更高，分别为 2.7%和 2.4%（OR，1.14；95%CI，1.05-1.23）。乙状结肠镜组有 33 例（0.05%）严重不良事件，而 FIT 组有 47 例（0.07%）（P=0.13）。
结论
与乙状结肠镜相比，重复 FIT 检查的参与率更高，可检测到更多的 CRC 和高级别腺瘤。穿孔和出血的风险相似。Clinicaltrials.gov，编号：NCT01538550。
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