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计算机辅助分析的广域跨上皮采样检测 Barrett 食管中的高级别异型增生和癌症:一项多中心随机研究。

Wide-area transepithelial sampling with computer-assisted analysis to detect high grade dysplasia and cancer in Barrett's esophagus: a multicenter randomized study.

机构信息

Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.

出版信息

Endoscopy. 2023 Apr;55(4):303-310. doi: 10.1055/a-1949-9542. Epub 2022 Sep 23.

DOI:10.1055/a-1949-9542
PMID:36150646
Abstract

BACKGROUND

Current surveillance for Barrett's esophagus (BE), consisting of four-quadrant random forceps biopsies (FBs), has an inherent risk of sampling error. Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). In this multicenter randomized trial, we aimed to evaluate WATS as a substitute for FB.

METHODS

Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice versa. All WATS samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Diagnostics laboratory. Similarly, all FBs were examined by two expert pathologists. The primary end point was concordance/discordance for detection of HGD/EAC between the two techniques.

RESULTS

172 patients were included, of whom 21 had HGD/EAC detected by both modalities, 18 had HGD/EAC detected by WATS but missed by FB, and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB ( = 0.36). Using WATS as an adjunct to FB significantly increased the detection of HGD/EAC vs. FB alone (absolute increase 10 % [95 %CI 6 % to 16 %]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95 %CI 5.9 to 7.1), 4.9 (95 %CI 4.1 to 5.4), and 11.2 (95 %CI 10.5 to 14.0), respectively.

CONCLUSIONS

Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for the detection of HGD/EAC as single modality.

摘要

背景

目前,巴雷特食管(BE)的监测采用四象限随机活检钳(FB),存在固有采样误差风险。大面积跨上皮采样(WATS)可能增加高级别异型增生(HGD)和食管腺癌(EAC)的检出率。在这项多中心随机试验中,我们旨在评估 WATS 替代 FB 的效果。

方法

在 17 家医院,我们对已知 BE 且最近有异型增生史、无可见病变的患者进行了随机分组,分别接受 WATS 后 FB 或反之。所有 WATS 样本均由 CDx 诊断实验室至少两名经验丰富的病理学家借助计算机辅助进行检查。同样,所有 FB 也由两名专家病理学家进行检查。主要终点是两种技术检测 HGD/EAC 的一致性/差异性。

结果

共纳入 172 例患者,其中 21 例两种方法均检出 HGD/EAC,18 例 WATS 检出而 FB 漏诊,12 例 FB 检出而 WATS 漏诊。WATS 和 FB 检测 HGD/EAC 的检出率无差异( = 0.36)。与 FB 相比,WATS 作为 FB 的辅助手段显著增加了 HGD/EAC 的检出率(绝对增加 10%[95%CI 6%至 16%])。单独 FB、单独 WATS 和联合应用的平均操作时间(分钟)分别为 6.6(95%CI 5.9 至 7.1)、4.9(95%CI 4.1 至 5.4)和 11.2(95%CI 10.5 至 14.0)。

结论

尽管 WATS 和 FB 的联合应用增加了 BE 患者中异型增生检出率,但我们并未发现 WATS 和 FB 单独应用在 HGD/EAC 检出方面存在统计学差异。

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