Gastroenterology Department, Hospital Clinic of Barcelona, Barcelona, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
BMC Med. 2020 Sep 18;18(1):255. doi: 10.1186/s12916-020-01717-4.
Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions.
The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC.
Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p = 0.002).
Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion.
ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.
结肠胶囊内镜（CCE）和 CT 结肠成像（CTC）是用于结直肠癌（CRC）筛查的微创技术。我们的目的是比较 CCE 和 CTC 在粪便免疫化学试验（FIT）阳性的 CRC 筛查计划参与者中识别结直肠肿瘤患者的能力。主要结局是比较 CCE 和 CTC 在检测有肿瘤病变患者方面的表现。
VICOCA 研究是一项前瞻性、单中心、随机试验，于 2014 年 3 月至 2016 年 5 月进行；邀请了 662 人，其中 349 人在结肠镜检查前被随机分配至 CCE 或 CTC 组。内镜医生对 CCE 和 CTC 的结果均不知情。
349 人入组：CEC 组 173 人，CTC 组 176 人。290 人同意参加：CEC 组 147 人，CTC 组 143 人。在意向性筛查分析中，CEC 组识别结直肠肿瘤患者的敏感性、特异性、阳性预测值和阴性预测值分别为 98.1%、76.6%、93.7%和 92.0%，CTC 组分别为 64.9%、95.7%、96.8%和 57.7%。在检测显著肿瘤性病变方面，CEC 和 CTC 的敏感性分别为 96.1%和 79.3%。CEC 组高级结直肠肿瘤的检出率高于 CTC 组（分别为 100%和 93.1%；RR=1.07；p=0.08）。CEC 和 CTC 均能识别所有癌症患者。CEC 组发现的任何病变患者多于 CTC 组（分别为 98.6%和 81.0%；RR=1.22；p=0.002）。
尽管两种技术在检测晚期结直肠肿瘤患者方面似乎相似，但 CCE 在检测任何肿瘤性病变方面更敏感。
ClinicalTrials.gov 标识符：NCT02081742。注册日期：2013 年 9 月 16 日。
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