第二代结肠胶囊内镜与结肠镜检查在小儿溃疡性结肠炎中的应用：一项试点研究。

Second-generation colon capsule endoscopy vs. colonoscopy in pediatric ulcerative colitis: a pilot study.

作者信息

Oliva Salvatore, Di Nardo Giovanni, Hassan Cesare, Spada Cristiano, Aloi Marina, Ferrari Federica, Redler Adriano, Costamagna Guido, Cucchiara Salvatore

机构信息

Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy.

Gastrointestinal Endoscopy Unit, Catholic University of Rome, Rome, Italy.

出版信息

Endoscopy. 2014 Jun;46(6):485-92. doi: 10.1055/s-0034-1365413. Epub 2014 Apr 28.

DOI:10.1055/s-0034-1365413

PMID:24777427

Abstract

BACKGROUND AND STUDY AIMS

Second-generation colon capsule endoscopy (CCE-2) may overcome the invasiveness of colonoscopy in the evaluation of mucosal inflammation, especially in pediatric ulcerative colitis. The aim of this pilot study was to determine the diagnostic accuracy of CCE-2 in evaluating disease activity, using colonoscopy as a gold standard. Disease extent, tolerability, interobserver agreement, and safety were also evaluated.

METHODS

A total of 30 consecutive pediatric patients with ulcerative colitis were prospectively enrolled (mean age 14.1 ± 3.2 years). Patients underwent CCE-2 followed by colonoscopy in the late afternoon or the following day. The blinded procedures were performed, and the diagnostic accuracy of CCE-2 to assess disease activity was determined using a modified Matts score, which classified patients as either normal (Matts score ≤ 6) or with active inflammation (Matts score > 6). Interobserver agreement was assessed using the kappa statistic.

RESULTS

One patient was excluded from the analysis because they were unable to swallow the capsule, leaving 29 patients available for analysis. The sensitivity of CCE-2 for disease activity was 96 % (95 % confidence interval [CI] 79 - 99) and specificity was 100 % (95 %CI 61 - 100). The positive and negative predictive values of CCE-2 were 100 % (95 %CI 85 - 100) and 85 % (95 %CI 49 - 97), respectively. No serious adverse events were reported. CCE-2 had a higher overall tolerability than colonoscopy (P < 0.05). Interobserver agreement was excellent in all cases (κ > 0.86).

CONCLUSIONS

Using a modified Matts score, CCE-2 was accurate in evaluating significant mucosal inflammation in children with ulcerative colitis.

TRIAL REGISTRATION

ClinicalTrials.gov -- NCT01740349.

摘要

背景与研究目的

第二代结肠胶囊内镜检查（CCE - 2）在评估黏膜炎症时，或许能够克服结肠镜检查的侵入性，尤其是在儿童溃疡性结肠炎的评估中。这项初步研究的目的是以结肠镜检查作为金标准，确定CCE - 2在评估疾病活动度方面的诊断准确性。同时还评估了病变范围、耐受性、观察者间一致性及安全性。

方法

前瞻性纳入30例连续的患有溃疡性结肠炎的儿科患者（平均年龄14.1 ± 3.2岁）。患者先接受CCE - 2检查，然后在下午晚些时候或次日接受结肠镜检查。采用盲法操作，使用改良的马茨评分来确定CCE - 2评估疾病活动度的诊断准确性，该评分将患者分为正常（马茨评分≤6）或有活动性炎症（马茨评分>6）。使用kappa统计量评估观察者间一致性。

结果

1例患者因无法吞咽胶囊被排除在分析之外，剩余29例患者可供分析。CCE - 2对疾病活动度的敏感性为96%（95%置信区间[CI] 79 - 99），特异性为100%（95%CI 61 - 100）。CCE - 2的阳性和阴性预测值分别为100%（95%CI 85 - 100）和85%（95%CI 49 - 97）。未报告严重不良事件。CCE - 2的总体耐受性高于结肠镜检查（P < 0.05）。所有病例的观察者间一致性均良好（κ>0.86）。