Johnson C Daniel, Chen Mei-Hsiu, Toledano Alicia Y, Heiken Jay P, Dachman Abraham, Kuo Mark D, Menias Christine O, Siewert Betina, Cheema Jugesh I, Obregon Richard G, Fidler Jeff L, Zimmerman Peter, Horton Karen M, Coakley Kevin, Iyer Revathy B, Hara Amy K, Halvorsen Robert A, Casola Giovanna, Yee Judy, Herman Benjamin A, Burgart Lawrence J, Limburg Paul J
Mayo Clinic Arizona, Scottsdale, AZ, USA.
N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.
Computed tomographic (CT) colonography is a noninvasive option in screening for colorectal cancer. However, its accuracy as a screening tool in asymptomatic adults has not been well defined.
We recruited 2600 asymptomatic study participants, 50 years of age or older, at 15 study centers. CT colonographic images were acquired with the use of standard bowel preparation, stool and fluid tagging, mechanical insufflation, and multidetector-row CT scanners (with 16 or more rows). Radiologists trained in CT colonography reported all lesions measuring 5 mm or more in diameter. Optical colonoscopy and histologic review were performed according to established clinical protocols at each center and served as the reference standard. The primary end point was detection by CT colonography of histologically confirmed large adenomas and adenocarcinomas (10 mm in diameter or larger) that had been detected by colonoscopy; detection of smaller colorectal lesions (6 to 9 mm in diameter) was also evaluated.
Complete data were available for 2531 participants (97%). For large adenomas and cancers, the mean (+/-SE) per-patient estimates of the sensitivity, specificity, positive and negative predictive values, and area under the receiver-operating-characteristic curve for CT colonography were 0.90+/-0.03, 0.86+/-0.02, 0.23+/-0.02, 0.99+/-<0.01, and 0.89+/-0.02, respectively. The sensitivity of 0.90 (i.e., 90%) indicates that CT colonography failed to detect a lesion measuring 10 mm or more in diameter in 10% of patients. The per-polyp sensitivity for large adenomas or cancers was 0.84+/-0.04. The per-patient sensitivity for detecting adenomas that were 6 mm or more in diameter was 0.78.
In this study of asymptomatic adults, CT colonographic screening identified 90% of subjects with adenomas or cancers measuring 10 mm or more in diameter. These findings augment published data on the role of CT colonography in screening patients with an average risk of colorectal cancer. (ClinicalTrials.gov number, NCT00084929; American College of Radiology Imaging Network [ACRIN] number, 6664.)
计算机断层扫描(CT)结肠成像术是一种用于筛查结直肠癌的非侵入性方法。然而,其作为无症状成年人筛查工具的准确性尚未得到明确界定。
我们在15个研究中心招募了2600名年龄在50岁及以上的无症状研究参与者。使用标准肠道准备、粪便和液体标记、机械充气以及多排探测器CT扫描仪(16排或更多排)获取CT结肠成像图像。接受CT结肠成像培训的放射科医生报告所有直径5毫米或更大的病变。每个中心根据既定临床方案进行光学结肠镜检查和组织学检查,并将其作为参考标准。主要终点是CT结肠成像术检测到经结肠镜检查发现且经组织学证实的直径10毫米或更大的大腺瘤和腺癌;同时也评估了对较小结直肠病变(直径6至9毫米)的检测情况。
2531名参与者(97%)有完整数据。对于大腺瘤和癌症,CT结肠成像术的敏感性、特异性、阳性和阴性预测值以及受试者操作特征曲线下面积的平均(±标准误)每例估计值分别为0.90±0.03、0.86±0.02、0.23±0.02、0.99±<0.01和0.89±0.02。0.90的敏感性(即90%)表明CT结肠成像术在10%的患者中未能检测到直径10毫米或更大的病变。大腺瘤或癌症的每息肉敏感性为0.84±0.04。检测直径6毫米或更大腺瘤的每例敏感性为0.78。
在这项针对无症状成年人的研究中,CT结肠成像筛查识别出了90%患有直径10毫米或更大腺瘤或癌症的受试者。这些发现补充了已发表的关于CT结肠成像术在筛查结直肠癌平均风险患者中的作用的数据。(ClinicalTrials.gov编号NCT00084929;美国放射学会成像网络[ACRIN]编号6664)