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粪便免疫化学检测(FIT)与结肠镜检查用于筛查和息肉切除后的监测:一项诊断准确性和成本效益研究。

Faecal immunochemical tests (FIT) versus colonoscopy for surveillance after screening and polypectomy: a diagnostic accuracy and cost-effectiveness study.

机构信息

Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Imperial College London, London, UK.

Bowel Cancer Screening Programme Southern Hub, Guildford, UK.

出版信息

Gut. 2019 Sep;68(9):1642-1652. doi: 10.1136/gutjnl-2018-317297. Epub 2018 Dec 11.

Abstract

OBJECTIVE

The English Bowel Cancer Screening Programme (BCSP) recommends 3 yearly colonoscopy surveillance for patients at intermediate risk of colorectal cancer (CRC) postpolypectomy (those with three to four small adenomas or one ≥10 mm). We investigated whether faecal immunochemical tests (FITs) could reduce surveillance burden on patients and endoscopy services.

DESIGN

Intermediate-risk patients (60-72 years) recommended 3 yearly surveillance were recruited within the BCSP (January 2012-December 2013). FITs were offered at 1, 2 and 3 years postpolypectomy. Invitees consenting and returning a year 1 FIT were included. Participants testing positive (haemoglobin ≥40 µg/g) at years one or two were offered colonoscopy early; all others were offered colonoscopy at 3 years. Diagnostic accuracy for CRC and advanced adenomas (AAs) was estimated considering multiple tests and thresholds. We calculated incremental costs per additional AA and CRC detected by colonoscopy versus FIT surveillance.

RESULTS

74% (5938/8009) of invitees were included in our study having participated at year 1. Of these, 97% returned FITs at years 2 and 3. Three-year cumulative positivity was 13% at the 40 µg/g haemoglobin threshold and 29% at 10 µg/g. 29 participants were diagnosed with CRC and 446 with AAs. Three-year programme sensitivities for CRC and AAs were, respectively, 59% and 33% at 40 µg/g, and 72% and 57% at 10 µg/g. Incremental costs per additional AA and CRC detected by colonoscopy versus FIT (40 µg/g) surveillance were £7354 and £180 778, respectively.

CONCLUSIONS

Replacing 3 yearly colonoscopy surveillance in intermediate-risk patients with annual FIT could reduce colonoscopies by 71%, significantly cut costs but could miss 30%-40% of CRCs and 40%-70% of AAs.

TRIAL REGISTRATION NUMBER

ISRCTN18040196; Results.

摘要

目的

英国结直肠癌筛查计划(BCSP)建议对接受内镜下息肉切除术的结直肠腺瘤患者(存在 3-4 枚小腺瘤或 1 枚≥10mm 腺瘤的中危患者),在息肉切除术后 3 年内进行结肠镜监测。我们研究粪便免疫化学检测(FIT)是否可以减轻患者和内镜服务的监测负担。

设计

BCSP 于 2012 年 1 月至 2013 年 12 月招募中危患者(年龄 60-72 岁),推荐每 3 年进行 1 次结肠镜监测。息肉切除术后 1、2、3 年进行 FIT 检查。邀请并返回 1 年 FIT 的患者被纳入研究。1 年和 2 年检测结果阳性(血红蛋白≥40μg/g)的患者行早期结肠镜检查;其余患者在 3 年后进行结肠镜检查。考虑多次检测和多个阈值,估计 CRC 和高级腺瘤(AA)的诊断准确性。我们计算了与 FIT 监测相比,通过结肠镜检查发现额外的 1 个 AA 和 CRC 的增量成本。

结果

74%(8009/5938)的受邀者参加了我们的研究,他们在第 1 年参与了研究。其中,97%的患者在第 2 年和第 3 年返回了 FIT 检测结果。在 40μg/g 血红蛋白的检测阈值下,3 年的累积阳性率为 13%,10μg/g 血红蛋白的累积阳性率为 29%。29 名患者被诊断为 CRC,446 名患者被诊断为 AA。在 40μg/g 血红蛋白的检测阈值下,CRC 和 AA 的 3 年方案敏感性分别为 59%和 33%,在 10μg/g 血红蛋白的检测阈值下,敏感性分别为 72%和 57%。与 FIT(40μg/g)监测相比,结肠镜检查发现额外的 1 个 AA 和 CRC 的增量成本分别为 7354 英镑和 180778 英镑。

结论

用每年 1 次的 FIT 替代中危患者 3 年的结肠镜监测,可以减少 71%的结肠镜检查,但可能会漏诊 30%-40%的 CRC 和 40%-70%的 AA。

试验注册号

ISRCTN83335118;结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0a6f/6709777/01cb6ff2d046/gutjnl-2018-317297f01.jpg

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