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虚拟染色内镜检查(I-SCAN)在林奇综合征患者中检测到更多息肉:一项随机对照交叉试验。

Virtual chromoendoscopy (I-SCAN) detects more polyps in patients with Lynch syndrome: a randomized controlled crossover trial.

作者信息

Bisschops Raf, Tejpar Sabine, Willekens Hilde, De Hertogh Gert, Van Cutsem Eric

机构信息

Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium.

Department of Pathology, University Hospital Leuven, Leuven, Belgium.

出版信息

Endoscopy. 2017 Apr;49(4):342-350. doi: 10.1055/s-0042-121005. Epub 2017 Jan 20.

DOI:10.1055/s-0042-121005
PMID:28107763
Abstract

UNLABELLED

(Virtual) chromoendoscopy detects more polyps than standard white-light endoscopy in patients with Lynch syndrome. Previous back-to-back trials did not randomize for the examination order, creating a possible bias in favor of chromoendoscopy. We aimed to assess the difference in polyp detection between high definition white-light endoscopy (HD-WLE) and virtual chromoendoscopy with I-SCAN in patients with Lynch syndrome.  In this prospective, controlled trial, patients were randomized to either HD-WLE followed by I-SCAN (Group 1; n = 31) or I-SCAN followed by HD-WLE (Group 2; n = 30). Polyps found during the first pass were removed. The primary end point of the study was the difference in adenoma detection between HD-WLE and I-SCAN, expressed as the miss rate for adenomas for each technique.  In Group 1, I-SCAN detected four additional patients with at least one adenoma, whereas HD-WLE did not increase the adenoma detection rate in Group 2 (relative risk [RR] 0.4;  = 0.08). In Group 1, five adenomas were detected and removed with HD-WLE and a second pass with I-SCAN detected a further eight adenomas. In Group 2, I-SCAN detected 15 adenomas and subsequent HD-WLE detected 2 additional adenomas. The adenoma miss rate was significantly higher for HD-WLE (62 %) compared with I-SCAN (12 %; RR 0.44, 95 % confidence interval [CI] 0.21 to 0.87;  = 0.007). The miss rate for lesions was 57 % and 24 %, respectively, and was significantly different in favor of I-SCAN (RR 0.54, 95 %CI 0.3 to 0.85;  = 0.005). The mean inspection time in both groups was not significantly different during first (485 vs. 536 seconds; 95 %CI - 139.91 to 33.34) or second pass (421 vs. 387 seconds; 95 %CI - 32.24 to 104.89).  Our data suggest that virtual chromoendoscopy with I-SCAN reduces the adenoma and polyp miss rate in patients with Lynch syndrome, independently of inspection time.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT01823471).

摘要

未标注

在林奇综合征患者中,(虚拟)色素内镜检查比标准白光内镜检查能检测出更多息肉。之前的背靠背试验未对检查顺序进行随机分组,可能导致有利于色素内镜检查的偏差。我们旨在评估高清白光内镜检查(HD-WLE)与采用I-SCAN的虚拟色素内镜检查在林奇综合征患者息肉检测方面的差异。在这项前瞻性对照试验中,患者被随机分为两组,一组先进行HD-WLE检查,然后进行I-SCAN检查(第1组;n = 31),另一组先进行I-SCAN检查,然后进行HD-WLE检查(第2组;n = 30)。首次检查中发现的息肉均被切除。该研究的主要终点是HD-WLE与I-SCAN在腺瘤检测方面的差异,以每种技术的腺瘤漏检率表示。在第1组中,I-SCAN多检测出4例至少有一个腺瘤的患者,而在第2组中HD-WLE并未提高腺瘤检测率(相对风险[RR] 0.4;P = 0.08)。在第1组中,HD-WLE检测并切除了5个腺瘤,I-SCAN再次检查又检测出8个腺瘤。在第2组中,I-SCAN检测出15个腺瘤,随后的HD-WLE又检测出2个腺瘤。HD-WLE的腺瘤漏检率(62%)显著高于I-SCAN(12%;RR 0.44,95%置信区间[CI] 0.21至0.87;P = 0.007)。病变的漏检率分别为57%和24%,I-SCAN明显更具优势(RR 0.54,95%CI 0.3至0.85;P = 0.005)。两组首次检查(485秒对536秒;95%CI -139.91至33.34)和再次检查(421秒对387秒;95%CI -32.24至104.89)的平均检查时间无显著差异。我们的数据表明,采用I-SCAN的虚拟色素内镜检查可降低林奇综合征患者的腺瘤和息肉漏检率,且与检查时间无关。试验注册:ClinicalTrials.gov(NCT01823471)。

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