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链接染色成像在上消化道肿瘤检测中的应用:一项随机试验。

Linked Color Imaging Focused on Neoplasm Detection in the Upper Gastrointestinal Tract : A Randomized Trial.

机构信息

Hokkaido University Hospital, Sapporo, Japan (S.O., M.T.).

Tokyo Medical and Dental University, Tokyo, Japan (K.K.).

出版信息

Ann Intern Med. 2021 Jan;174(1):18-24. doi: 10.7326/M19-2561. Epub 2020 Oct 20.

DOI:10.7326/M19-2561
PMID:33076693
Abstract

BACKGROUND

Linked color imaging (LCI) is a new image-enhanced endoscopy technique that allows users to recognize slight differences in mucosal color.

OBJECTIVE

To compare the performance of LCI with white light imaging (WLI) in detecting neoplastic lesions in the upper gastrointestinal tract.

DESIGN

A controlled, multicenter trial with randomization using minimization. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000023863).

SETTING

16 university hospitals and 3 tertiary care hospitals in Japan.

PATIENTS

1502 patients with known previous or current cancer of the gastrointestinal tract and undergoing surveillance for gastrointestinal cancer.

INTERVENTION

WLI followed by LCI examination (WLI group) or LCI followed by WLI examination (LCI group).

MEASUREMENTS

Diagnosis of 1 or more neoplastic lesions in the pharynx, esophagus, or stomach in the first examination (primary outcome) and 1 or more neoplastic lesions overlooked in the first examination (secondary outcome).

RESULTS

752 patients were assigned to the WLI group and 750 to the LCI group. The percentage of patients with 1 or more neoplastic lesions diagnosed in the first examination was higher with LCI than with WLI (60 of 750 patients or 8.0% [95% CI, 6.2% to 10.2%] vs. 36 of 752 patients or 4.8% [CI, 3.4% to 6.6%]; risk ratio, 1.67 [CI, 1.12 to 2.50;  = 0.011]). The proportion with overlooked neoplasms was lower in the LCI group than in the WLI group (5 of 750 patients or 0.67% [CI, 0.2% to 1.6%] vs. 26 of 752 patients or 3.5% [CI, 2.3% to 5.0%]; risk ratio, 0.19 [CI, 0.07 to 0.50]).

LIMITATION

Endoscopists were not blinded.

CONCLUSION

LCI is more effective than WLI for detecting neoplastic lesions in the pharynx, esophagus, and stomach.

PRIMARY FUNDING SOURCE

Fujifilm Corporation.

摘要

背景

联合显色成像(LCI)是一种新的图像增强内镜技术,可使使用者识别出黏膜颜色的细微差异。

目的

比较 LCI 与白光成像(WLI)在检测上消化道肿瘤性病变方面的性能。

设计

采用对照、多中心、采用最小化随机分组的临床试验。(日本大学医院医学信息网临床试验注册中心:UMIN000023863)。

地点

日本 16 所大学医院和 3 所三级保健医院。

患者

1502 例已知胃肠道既往或目前患有癌症且正在接受胃肠道癌症监测的患者。

干预措施

WLI 后行 LCI 检查(WLI 组)或 LCI 后行 WLI 检查(LCI 组)。

测量指标

首次检查时诊断出 1 个或多个咽部、食管或胃部肿瘤性病变(主要结局)和首次检查时漏诊的 1 个或多个肿瘤性病变(次要结局)。

结果

752 例患者被分配至 WLI 组,750 例患者被分配至 LCI 组。LCI 组首次检查时诊断出 1 个或多个肿瘤性病变的患者比例高于 WLI 组(750 例患者中有 60 例或 8.0%[95%CI,6.2%10.2%] vs. 752 例患者中有 36 例或 4.8%[CI,3.4%6.6%];风险比,1.67[CI,1.122.50;P=0.011])。LCI 组漏诊肿瘤性病变的比例低于 WLI 组(750 例患者中有 5 例或 0.67%[CI,0.2%1.6%] vs. 752 例患者中有 26 例或 3.5%[CI,2.3%5.0%];风险比,0.19[CI,0.070.50])。

局限性

内镜医师未设盲。

结论

LCI 比 WLI 更有效地检测上消化道的肿瘤性病变。

主要资金来源

富士胶片公司。

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