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一项比较窄带成像与白光检查的随机串联结肠镜检查试验,以比较肿瘤漏诊率。

A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates.

作者信息

Kaltenbach T, Friedland S, Soetikno R

机构信息

VA Palo Alto Health Care System, Stanford University School of Medicine, 3801 Miranda Ave, Palo Alto, CA 94304, USA.

出版信息

Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3.

Abstract

OBJECTIVE

Colonoscopy, the "gold standard" screening test for colorectal cancer (CRC), has known diagnostic limitations. Advances in endoscope technology have focused on improving mucosal visualisation. In addition to increased angle of view and resolution features, recent colonoscopes have non-white-light optics, such as narrow band imaging (NBI), to enhance image contrast. We aimed to study the neoplasia diagnostic characteristics of NBI, by comparing the neoplasm miss rate when the colonoscopy was performed under NBI versus white light (WL).

DESIGN

Randomised controlled trial.

SETTING

US Veterans hospital.

PATIENTS

Elective colonoscopy adults.

INTERVENTION

We randomly assigned patients to undergo a colonoscopic examination using NBI or WL. All patients underwent a second examination using WL, as the reference standard.

MAIN OUTCOME MEASURES

The primary end point was the difference in the neoplasm miss rate, and secondary outcome was the neoplasm detection rate.

RESULTS

In 276 tandem colonoscopy patients, there was no significant difference of miss or detection rates between NBI or WL colonoscopy techniques. Of the 135 patients in the NBI group, 17 patients (12.6%; 95% confidence interval (CI) 7.5 to 19.4%) had a missed neoplasm, as compared with 17 of the 141 patients (12.1%; 95% CI 7.2 to 18.6%) in the WL group, with a miss rate risk difference of 0.5% (95% CI -7.2 to 8.3). 130 patients (47%) had at least one neoplasm. Missed lesions with NBI showed similar characteristics to those missed with WL. All missed neoplasms were tubular adenomas, the majority (78%) was < or = 5 mm and none were larger than 1 cm (one-sided 95% CI up to 1%). Nonpolypoid lesions represented 35% (13/37) of missed neoplasms.

INTERPRETATION

NBI did not improve the colorectal neoplasm miss rate compared to WL; the miss rate for advanced adenomas was less than 1% and for all adenomas was 12%. The neoplasm detection rates were similar high using NBI or WL; almost a half the study patients had at least one adenoma. Clinicaltrials.gov identifier: NCT00628147.

摘要

目的

结肠镜检查是结直肠癌(CRC)的“金标准”筛查试验,但已知其存在诊断局限性。内窥镜技术的进步主要集中在改善黏膜可视化方面。除了增加视角和分辨率外,近期的结肠镜还具备非白光光学技术,如窄带成像(NBI),以增强图像对比度。我们旨在通过比较在NBI和白光(WL)条件下进行结肠镜检查时的肿瘤漏诊率,研究NBI对肿瘤的诊断特征。

设计

随机对照试验。

地点

美国退伍军人医院。

患者

择期进行结肠镜检查的成年人。

干预措施

我们将患者随机分配,使其分别接受使用NBI或WL的结肠镜检查。所有患者均接受第二次使用WL的检查,作为参考标准。

主要观察指标

主要终点是肿瘤漏诊率的差异,次要结果是肿瘤检出率。

结果

在276例接受串联结肠镜检查的患者中,NBI或WL结肠镜检查技术在漏诊率或检出率方面无显著差异。NBI组的135例患者中,有17例(12.6%;95%置信区间[CI] 7.5至19.4%)存在漏诊肿瘤,而WL组的141例患者中有17例(12.1%;95% CI 7.2至18.6%)漏诊,漏诊率风险差异为0.5%(95% CI -7.2至8.3)。130例患者(47%)至少有一个肿瘤。NBI漏诊的病变与WL漏诊的病变表现出相似特征。所有漏诊肿瘤均为管状腺瘤,大多数(78%)直径≤5mm,且无一大于1cm(单侧95% CI上限为1%)。非息肉样病变占漏诊肿瘤的35%(13/37)。

解读

与WL相比,NBI并未提高结直肠肿瘤的漏诊率;进展性腺瘤的漏诊率小于1%,所有腺瘤的漏诊率为12%。使用NBI或WL时肿瘤检出率同样较高;近一半的研究患者至少有一个腺瘤。Clinicaltrials.gov标识符:NCT00628147。

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