Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University Hospital, Indianapolis, Indiana.
Digestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel.
Gastroenterology. 2015 May;148(5):948-957.e2. doi: 10.1053/j.gastro.2015.01.025. Epub 2015 Jan 22.
BACKGROUND & AIMS: Capsule colonoscopy is a minimally invasive imaging method. We measured the accuracy of this technology in detecting polyps 6 mm or larger in an average-risk screening population.
In a prospective study, asymptomatic subjects (n = 884) underwent capsule colonoscopy followed by conventional colonoscopy (the reference) several weeks later, with an endoscopist blinded to capsule results, at 10 centers in the United States and 6 centers in Israel from June 2011 through April 2012. An unblinded colonoscopy was performed on subjects found to have lesions 6 mm or larger by capsule but not conventional colonoscopy.
Among the 884 subjects enrolled, 695 (79%) were included in the analysis of capsule performance for all polyps. There were 77 exclusions (9%) for inadequate cleansing and whole-colon capsule transit time fewer than 40 minutes, 45 exclusions (5%) before capsule ingestion, 15 exclusions (2%) after ingestion and before colonoscopy, and 15 exclusions (2%) for site termination. Capsule colonoscopy identified subjects with 1 or more polyps 6 mm or larger with 81% sensitivity (95% confidence interval [CI], 77%-84%) and 93% specificity (95% CI, 91%-95%), and polyps 10 mm or larger with 80% sensitivity (95% CI, 74%-86%) and 97% specificity (95% CI, 96%-98%). Capsule colonoscopy identified subjects with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity (95% CI, 82%-93) and 82% specificity (95% CI, 80%-83%), and 10 mm or larger with 92% sensitivity (95% CI, 82%-97%) and 95% specificity (95% CI, 94%-95%). Sessile serrated polyps and hyperplastic polyps accounted for 26% and 37%, respectively, of false-negative findings from capsule analyses.
In an average-risk screening population, technically adequate capsule colonoscopy identified individuals with 1 or more conventional adenomas 6 mm or larger with 88% sensitivity and 82% specificity. Capsule performance seems adequate for patients who cannot undergo colonoscopy or who had incomplete colonoscopies. Additional studies are needed to improve capsule detection of serrated lesions. Clinicaltrials.gov number: NCT01372878.
胶囊结肠镜检查是一种微创成像方法。我们测量了该技术在检测平均风险筛查人群中 6 毫米或更大息肉的准确性。
在一项前瞻性研究中，884 名无症状受试者于 2011 年 6 月至 2012 年 4 月在美国 10 个中心和以色列 6 个中心接受胶囊结肠镜检查，随后数周内进行常规结肠镜检查（作为参考），内镜医师对胶囊结果进行盲法评估。对通过胶囊检查发现 6 毫米或更大的病变但未通过常规结肠镜检查的受试者进行非盲法结肠镜检查。
在纳入的 884 名受试者中，695 名（79%）受试者被纳入所有息肉的胶囊性能分析。因肠道准备不足和整个结肠胶囊通过时间少于 40 分钟而排除 77 例（9%），因在服用胶囊前存在 45 例（5%）情况而排除，因在服用胶囊后和结肠镜检查前存在 15 例（2%）情况而排除，因部位终止而排除 15 例（2%）。胶囊结肠镜检查发现 1 个或多个 6 毫米或更大息肉的受试者，其敏感性为 81%（95%置信区间[CI]，77%-84%），特异性为 93%（95%CI，91%-95%），10 毫米或更大息肉的敏感性为 80%（95%CI，74%-86%），特异性为 97%（95%CI，96%-98%）。胶囊结肠镜检查发现 1 个或多个 6 毫米或更大的传统腺瘤的受试者，其敏感性为 88%（95%CI，82%-93%），特异性为 82%（95%CI，80%-83%），10 毫米或更大的腺瘤的敏感性为 92%（95%CI，82%-97%），特异性为 95%（95%CI，94%-95%）。检测出的假阴性结果中，无蒂锯齿状息肉和增生性息肉分别占 26%和 37%。
在平均风险筛查人群中，技术上适当的胶囊结肠镜检查发现 1 个或多个 6 毫米或更大的传统腺瘤，敏感性为 88%，特异性为 82%。对于不能进行结肠镜检查或结肠镜检查不完全的患者，胶囊检查似乎是有效的。需要进一步研究以提高胶囊对锯齿状病变的检测能力。临床试验注册号：NCT01372878。
