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结肠镜检查不完全的患者中结肠胶囊与 CT 结肠成像的比较:一项前瞻性、对照试验。

Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial.

机构信息

Digestive Endoscopy Unit, Catholic University, Rome, Italy.

Department of Bioimaging and Radiological Sciences, Catholic University, Rome, Italy.

出版信息

Gut. 2015 Feb;64(2):272-81. doi: 10.1136/gutjnl-2013-306550. Epub 2014 Jun 24.

DOI:10.1136/gutjnl-2013-306550
PMID:24964317
Abstract

OBJECTIVE

In case of incomplete colonoscopy, several radiologic methods have traditionally been used, but more recently, capsule endoscopy was also shown to be accurate. Aim of this study was to compare colon capsule endoscopy (CCE) and CT colonography (CTC) in a prospective cohort of patients with incomplete colonoscopy.

DESIGN

Consecutive patients with a previous incomplete colonoscopy underwent CCE and CTC followed by colonoscopy in case of positive findings on either test (polyps/mass lesions ≥6 mm). Clinical follow-up was performed in the other cases to rule out missed cancer. CTC was performed after colon capsule excretion or 10-12 h postingestion. Since the gold standard colonoscopy was performed only in positive cases, diagnostic yield and positive predictive values of CCE and CTC were used as study end-points.

RESULTS

100 patients were enrolled. CCE and CTC were able to achieve complete colonic evaluation in 98% of cases. In a per-patient analysis for polyps ≥6 mm, CCE detected 24 patients (24.5%) and CTC 12 patients (12.2%). The relative sensitivity of CCE compared to CTC was 2.0 (95% CI 1.34 to 2.98), indicating a significant increase in sensitivity for lesions ≥6 mm. Of larger polyps (≥10 mm), these values were 5.1% for CCE and 3.1% for CTC (relative sensitivity: 1.67 (95% CI 0.69 to 4.00)). Positive predictive values for polyps ≥6 mm and ≥10 mm were 96% and 85.7%, and 83.3% and 100% for CCE and CTC, respectively. No missed cancer occurred at clinical follow-up of a mean of 20 months.

CONCLUSIONS

CCE and CTC were of comparable efficacy in completing colon evaluation after incomplete colonoscopy; the overall diagnostic yield of colon capsule was superior to CTC.

TRIAL REGISTRATION NUMBER

NCT01525940.

摘要

目的

在结肠镜检查不完全的情况下,传统上使用了几种放射学方法,但最近胶囊内镜检查也被证明是准确的。本研究的目的是比较不完全结肠镜检查后的胶囊结肠镜检查(CCE)和 CT 结肠成像(CTC)。

设计

连续的结肠镜检查不完全的患者接受 CCE 和 CTC 检查,如果两种检查均发现阳性结果(息肉/肿块≥6mm),则进行结肠镜检查。在其他情况下进行临床随访以排除漏诊的癌症。CTC 在胶囊排出后或摄入后 10-12 小时进行。由于金标准结肠镜检查仅在阳性病例中进行,因此将 CCE 和 CTC 的诊断检出率和阳性预测值作为研究终点。

结果

共纳入 100 例患者。CCE 和 CTC 能够在 98%的病例中实现完全结肠评估。在每例患者的≥6mm 息肉分析中,CCE 检测到 24 例(24.5%),CTC 检测到 12 例(12.2%)。与 CTC 相比,CCE 的相对敏感性为 2.0(95%CI 1.34-2.98),表明对≥6mm 病变的敏感性显著增加。对于较大的息肉(≥10mm),CCE 的这些值为 5.1%,CTC 的值为 3.1%(相对敏感性:1.67(95%CI 0.69-4.00))。≥6mm 和≥10mm 息肉的阳性预测值分别为 96%和 85.7%,CCE 和 CTC 的阳性预测值分别为 83.3%和 100%。在平均 20 个月的临床随访中,没有漏诊癌症。

结论

CCE 和 CTC 在不完全结肠镜检查后完成结肠评估的效果相当;结肠胶囊的总体诊断检出率优于 CTC。

试验注册号

NCT01525940。

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