前瞻性、随机、背靠背试验评估 i-SCAN 在结肠镜筛查中的作用。
Prospective, randomized, back-to-back trial evaluating the usefulness of i-SCAN in screening colonoscopy.
机构信息
Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.
出版信息
Gastrointest Endosc. 2012 May;75(5):1011-1021.e2. doi: 10.1016/j.gie.2011.11.040. Epub 2012 Feb 28.
BACKGROUND
The newly developed i-SCAN application can theoretically maximize the effectiveness of colonoscopy. However, the practical usefulness of the i-SCAN application during screening colonoscopy has not been assessed.
OBJECTIVE
To assess the efficacy of the i-SCAN application during screening colonoscopy.
DESIGN
A prospective, randomized trial that used a modified, back-to-back colonoscopy.
SETTING
Academic hospital.
PATIENTS
This study involved 389 asymptomatic, consecutive, average-risk patients who underwent screening colonoscopy.
INTERVENTION
The patients were randomized to the first withdrawal with either conventional high-definition white light (HDWL group; n = 119), i-SCAN contrast/surface enhancement (CE/SE) mode (i-SCAN1 group; n = 115), or i-SCAN CE/SE/tone enhancement-colorectal mode (i-SCAN2 group; n = 118). All patients underwent a second examination with HDWL as the criterion standard.
MAIN OUTCOME MEASUREMENTS
The primary outcome measurement was the adenoma detection rate and adenoma miss rate. The secondary outcome measurement was the accuracy of the histologic prediction of neoplastic and nonneoplastic polyps.
RESULTS
The adenoma detection rates during the first withdrawal of HDWL, i-SCAN1, and i-SCAN2 were 31.9%, 36.5%, and 33.1%, respectively (P = .742), and the adenoma miss rates of each group were 22.9%, 19.3%, and 15.9%, respectively (P = .513). Based on the multivariate analysis, the application of i-SCAN was not associated with an improvement in adenoma detection and the prevention of missed polyps. However, the prediction of neoplastic and nonneoplastic colorectal lesions was more precise in the i-SCAN2 group compared with the HDWL group (accuracy 79.3% vs 75.5%, P = .029; sensitivity 86.5% vs 72.6%, P = .020; and specificity 91.4% vs 80.6%, P = .040).
LIMITATIONS
Single-center trial.
CONCLUSION
i-SCAN during the screening colonoscopy may fail to improve adenoma detection and the prevention of missed polyps, but i-SCAN appears to be effective for real-time histologic prediction of polyps compared with conventional HDWL colonoscopy. (
CLINICAL TRIAL REGISTRATION NUMBER
NCT01417611.).
背景
新开发的 i-SCAN 应用程序理论上可以最大限度地提高结肠镜检查的效果。然而，i-SCAN 应用程序在筛查结肠镜检查中的实际用途尚未得到评估。
目的
评估 i-SCAN 应用程序在筛查结肠镜检查中的功效。
设计
前瞻性、随机试验，采用改良的、背靠背结肠镜检查。
地点
学术医院。
患者
这项研究涉及 389 名无症状、连续、平均风险的接受筛查性结肠镜检查的患者。
干预措施
患者被随机分为首次退镜时分别使用常规高清白光（HDWL 组；n = 119）、i-SCAN 对比/表面增强（CE/SE）模式（i-SCAN1 组；n = 115）或 i-SCAN CE/SE/色调增强-结直肠模式（i-SCAN2 组；n = 118）。所有患者均进行第二次检查，以 HDWL 作为标准。
主要观察指标
主要观察指标是腺瘤检出率和腺瘤漏诊率。次要观察指标是对肿瘤性和非肿瘤性息肉的组织学预测的准确性。
结果
HDWL、i-SCAN1 和 i-SCAN2 首次退镜时的腺瘤检出率分别为 31.9%、36.5%和 33.1%（P =.742），每组的腺瘤漏诊率分别为 22.9%、19.3%和 15.9%（P =.513）。基于多变量分析，i-SCAN 的应用与腺瘤检出率的提高和息肉漏诊的预防无关。然而，与 HDWL 组相比，i-SCAN2 组对结直肠肿瘤性和非肿瘤性病变的预测更为准确（准确性 79.3%比 75.5%，P =.029；敏感性 86.5%比 72.6%，P =.020；特异性 91.4%比 80.6%，P =.040）。
局限性
单中心试验。
结论
i-SCAN 用于筛查结肠镜检查可能无法提高腺瘤检出率和预防息肉漏诊，但与常规 HDWL 结肠镜检查相比，i-SCAN 似乎可有效实时进行息肉的组织学预测。（临床试验注册号：NCT01417611）。
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