Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands; Robarts Clinical Trials, Inc, Amsterdam, The Netherlands and London, Ontario, Canada.
Inflammatory Bowel Disease Unit, Academic Medical Centre, Amsterdam, The Netherlands.
Clin Gastroenterol Hepatol. 2015 Aug;13(8):1480-6.e3. doi: 10.1016/j.cgh.2015.01.031. Epub 2015 Mar 21.
BACKGROUND & AIMS: The second-generation Pillcam Colon Capsule Endoscope (PCCE-2; Given Imaging Ltd, Yoqneam, Israel) is an ingestible capsule for visualization of the colon. We performed a multicenter pilot study to assess its safety and feasibility in evaluating the severity of Crohn's disease (CD).
In a prospective study, 40 patients with active colonic CD underwent PCCE-2 and optical colonoscopy procedures. Using both techniques, we generated values for the Crohn's Disease Endoscopic Index of Severity (CDEIS), the Simple Endoscopic Score for CD, and global evaluation of lesion severity. In the first stage of the study, we calculated the correlation between PCCE-2 and optical colonoscopy scores. In the second stage, we performed interobserver agreement analysis for a random subset of 20 PCCE-2 recordings, graded in duplicate by 2 independent readers.
There was substantial agreement between PCCE-2 and optical colonoscopy in the measurement of the CDEIS (intraclass correlation coefficient [ICC], 0.65; 95% confidence interval [CI], 0.43-0.80). There was substantial interobserver agreement between 2 independent PCCE-2 readers for the CDEIS (ICC, 0.67; 95% CI, 0.35-0.86) and the Simple Endoscopic Score for CD (ICC, 0.66; 95% CI, 0.32-0.85). However, the PCCE-2 scoring systematically underestimated the severity of disease compared with optical colonoscopy; based on our results, PCCE-2 detected colonic ulcerations with 86% sensitivity and 40% specificity. No adverse events were observed and PCCE-2 was better tolerated than colonoscopy.
PCCE-2 is feasible, safe, and well tolerated for the assessment of mucosal CD activity in selected populations. Larger studies are needed to assess its operating characteristics further. European clinical trials database number: 2014-003854-15.
第二代 Pillcam 结肠胶囊内镜（PCCE-2；Given Imaging Ltd，以色列约克尼姆）是一种用于可视化结肠的可摄入胶囊。我们进行了一项多中心试点研究，以评估其在评估克罗恩病（CD）严重程度方面的安全性和可行性。
在一项前瞻性研究中，40 名活动性结肠 CD 患者接受了 PCCE-2 和光学结肠镜检查。使用这两种技术，我们生成了克罗恩病内镜严重指数（CDEIS）、简单 CD 内镜评分和病变严重程度的整体评估值。在研究的第一阶段，我们计算了 PCCE-2 和光学结肠镜评分之间的相关性。在第二阶段，我们对 20 份随机 PCCE-2 记录进行了双份独立观察者的一致性分析。
PCCE-2 与光学结肠镜在 CDEIS 的测量上具有实质性一致性（组内相关系数[ICC]，0.65；95%置信区间[CI]，0.43-0.80）。两名独立的 PCCE-2 读者对 CDEIS（ICC，0.67；95%CI，0.35-0.86）和简单 CD 内镜评分（ICC，0.66；95%CI，0.32-0.85）的一致性也很高。然而，与光学结肠镜相比，PCCE-2 评分系统地低估了疾病的严重程度；根据我们的结果，PCCE-2 检测到结肠溃疡的敏感性为 86%，特异性为 40%。未观察到不良事件，PCCE-2 比结肠镜更耐受。
PCCE-2 是可行的、安全的，并且在选择人群中用于评估黏膜 CD 活性时耐受性良好。需要更大的研究来进一步评估其操作特征。欧洲临床试验数据库编号：2014-003854-15。
