Background

Capsule endoscopy (CE) is an important modality for monitoring of Crohn’s disease (CD). We recently established that small bowel (SB) inflammation on CE quantified by a Lewis score >350 accurately predicts risk of relapse within 2 years in CD patients in clinical remission. Recently, a novel pan-enteric capsule (PillCam Crohn’s (PCCE), Medtronic, USA) was approved for use. However, no quantitative index for pan-enteric PCCE is currently available. The current study was undertaken as a sub-study of a prospective randomised controlled CURE-CD trial aiming to optimise treatment of CD patients in remission using a PCCE- based treat-to-target approach; the aim of this ancillary study was to compare the correlation and reliability of the novel PCCE inflamatory score (Eliakim score) with the Lewis score as performed by 2 independent experienced CE readers.

Methods

The study cohort includes CD patients in clinical remission (CDAI<150). The patients were prospectively enrolled and underwent patency capsule evaluation; if excreted within 30 h, PCCE was performed following bowel preparation. PCCE was repeated every 6 months; if no colonic disease was detected on first PCCE, subsequent examinations were performed without colonic preparation. Each PCCE was independently reviewed by 2 experienced readers (RE (reader 1);UK (reader 2)). All studies were scored using the Lewis score and Eliakim score (comprised of a sum of scores for most common and most severe lesions multiplied by percentage of involvement per bowel segment (3 for small bowel and 2 for colon) with an additional stricture score). Pearson’s and Spearman’ correlation, Cohen’s kappa and inter-rater reliability coefficient (IRC) between the scores and the readers were calculated as appropriate.

Results

Forty PCCE exams were included. The median LS was 225 for both readers (interquartile range (IQR)—157–815 for reader 1, 33- 1125 for reader 2). Both readers identified significant SB inflammation (LS>350) in 17/40 (42.5%) of the patients with strong agreement between the readers (Spearman’s r = 0.87, p < 0.0001). The median PCCE score was 6 (4–14.75) and 4 (2–14.75) for reader 1 and 2, respectively. There was a high IRC between the two readers for LS (0.88, p < 0.0001 for absolute agreement) and PCCE score (0.91, p < 0.0001). For the small bowel, the correlation between LS and PCCE was moderate for reader 1 (Pearson’s r = 0.72, p < 0.0001 and strong for reader 2 Pearson’s r = 0.84, p < 0.0001).

Conclusion

There is a need for a quantitative pan-enteric score for the novel Pillcam Crohns capsule. The presently proposed score, while mandating further clinical validation, has strong inter-reader reliability and moderate-to-strong correlation with the validated small bowel capsule score (LS)

中文翻译：

---

P160一种新颖的PillCam克罗恩氏胶囊评分（Eliakim评分），用于量化克罗恩氏病的粘膜炎症

背景

胶囊内窥镜检查（CE）是监测克罗恩病（CD）的重要方式。我们最近确定，通过Lewis得分> 350量化的CE小肠（SB）炎症可准确预测临床缓解的CD患者在2年内复发的风险。最近，一种新型的全肠胃胶囊（美国Medtronic的PillCam Crohn's（PCCE））被批准使用。但是，目前尚无用于全肠PCCE的定量指标。本研究是一项前瞻性随机对照CURE-CD试验的子研究，旨在通过基于PCCE的靶向治疗方法优化缓解期CD患者的治疗。

方法

研究人群包括临床缓解的CD患者（CDAI <150）。对这些患者进行前瞻性研究，并进行通畅胶囊评估。如果在30小时内排泄，则在肠道准备后进行PCCE。每6个月重复一次PCCE；如果在第一次PCCE上未检测到结肠疾病，则无需进行结肠准备就可以进行后续检查。每个PCCE均由2位经验丰富的读者（RE（读者1）； UK（读者2））独立审查。所有研究均使用Lewis评分和Eliakim评分（由最常见和最严重病变的评分总和乘以每个肠段的受累百分比（小肠为3，结肠为2）加上其他狭窄评分来评分。皮尔森和斯皮尔曼的相关性，

结果

包括四十次PCCE考试。两个阅读器的中位LS为225（阅读器1的四分位数间距（IQR）-157-815），阅读器2的中位数LS为33-1125）。两位读者均在17/40（42.5％）的患者中发现了严重的SB炎症（LS> 350），并且阅读者之间有很强的一致性（Spearman's r = 0.87，p <0.0001）。阅读器1和2的PCCE得分中位数分别为6（4-14.75）和4（2-14.75）。两名读者在LS上的IRC较高（对于绝对一致性，为0.88，p <0.0001）和PCCE评分（0.91，p <0.0001）。对于小肠，阅读器1的LS和PCCE之间的相关性中等（皮尔逊r = 0.72，p <0.0001，阅读器2皮尔逊r = 0.84，p <0.0001）。

结论

对于新型的Pillcam Crohns胶囊，需要定量的全肠评分。当前建议的评分，尽管需要进一步的临床验证，但具有强大的阅读器间可靠性，并且与经过验证的小肠胶囊评分（LS）具有中等至强相关性