Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study)
Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study)
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DOI：
10.1136/gutjnl-2020-322578
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发表时间：
2021-11-01
期刊：
影响因子：
24.5
通讯作者：
Rex, Douglas K.
中科院分区：
文献类型：
--
作者：
Cash, Brooks D.;Fleisher, Mark R.;Rex, Douglas K.
与光学结肠镜检查 (OC) 相比，客观结肠胶囊内窥镜检查 (CCE) 在结直肠肿瘤检测方面显示出良好的前景，但尚未与一般风险筛查患者中的其他筛查测试进行比较。 设计 50 至 75 岁的患者（非裔美国人，45-75 岁）被随机分配接受 CCE 或 CT 结肠镜检查 (CTC) 和随后盲法 OC。主要终点是使用 CCE 或 CTC 对≥ 6 mm 息肉的诊断率。次要终点包括大小和组织学的准确性、检查完整性、息肉和腺瘤≥ 6 mm 和≥ 10 mm 的受试者数量/比例、受试者满意度和安全性。 结果 在 320 名入组受试者中，286 名 (89.4%) 的数据可评估。经 OC 确认患有任何息肉 >= 6 mm 的受试者比例，CCE 为 31.6%，而 CTC 为 8.6%（pPr 非劣效性和优效性 = 0.999）。 CCE 对>= 10 mm 息肉的诊断率为 13.5%，而 CTC 为 6.3%（pPr 非劣效性=0.9954）。 CCE对≥6mm息肉的敏感度和特异度分别为79.2%和96.3%，而CTC的敏感度和特异度分别为26.8%和98.9%。 CCE 对≥ 10 mm 息肉的敏感性和特异性分别为 85.7% 和 98.2%，而 CTC 的敏感性和特异性分别为 50% 和 99.1%。两项测试均具有良好的耐受性/安全性。结论 CCE 在检测 >= 6 mm 息肉方面优于 CTC，在识别 >= 10 mm 息肉方面也不逊色。作为结直肠肿瘤筛查试验，CCE 应被视为与 CTC 相当或优于 CTC，尽管这两种试验都不如 OC 有效。
Objective Colon capsule endoscopy (CCE) has shown promise for colorectal neoplasia detection compared with optical colonoscopy (OC), but has not been compared with other screening tests in average risk screening patients.Design Patients 50 to 75 years of age (African Americans, 45-75 years) were randomised to CCE or CT colonography (CTC) and subsequent blinded OC. The primary endpoint was diagnostic yield of polyps >= 6 mm with CCE or CTC. Secondary endpoints included accuracy for size and histology, examination completeness, number/proportion of subjects with polyps and adenomas >= 6 mm and >= 10 mm, subject satisfaction and safety.Results From 320 enrolled subjects, data from 286 (89.4%) were evaluable. The proportion of subjects with any polyp >= 6 mm confirmed by OC was 31.6% for CCE versus 8.6% for CTC (pPr non-inferiority and superiority=0.999). The diagnostic yield of polyps >= 10 mm was 13.5% with CCE versus 6.3% with CTC (pPr non-inferiority=0.9954). The sensitivity and specificity of CCE for polyps >= 6 mm was 79.2% and 96.3% while that of CTC was 26.8% and 98.9%. The sensitivity and specificity of CCE for polyps >= 10 mm was 85.7% and 98.2% compared with 50% and 99.1% for CTC. Both tests were well tolerated/safe.Conclusion CCE was superior to CTC for detection of polyps >= 6 mm and non-inferior for identification of polyps >= 10 mm. CCE should be considered comparable or superior to CTC as a colorectal neoplasia screening test, although neither test is as effective as OC.