Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging.
Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging.
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DOI：
10.1136/gutjnl-2019-319631
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发表时间：
2021-01
期刊：
影响因子：
24.5
通讯作者：
Muto M
中科院分区：
文献类型：
--
作者：
Yoshida N;Doyama H;Yano T;Horimatsu T;Uedo N;Yamamoto Y;Kakushima N;Kanzaki H;Hori S;Yao K;Oda I;Katada C;Yokoi C;Ohata K;Yoshimura K;Ishikawa H;Muto M
胃癌的早期发现一直是高发地区的主要工作主题。先进的成像方法，如第二代窄带成像（2G-NBI）是否可以提高早期检测，目前尚不清楚。这项开放标签、随机、对照串联试验在13家医院进行。胃癌风险增加的患者被随机分配到由同一检查者进行的原发性白色光成像（WLI），然后是继发性2G-NBI（WLI组：n=2258）和原发性2G-NBI，然后是继发性WLI（2G-NBI组：n=2265）。对两组疑似早期胃癌（EGC）病变进行活检。主要终点是初步检查中EGC患者的比率。主要次要终点是检测到的可疑病变（初步检查）中EGC的阳性预测值（PPV）。在初次EGD期间，WLI组和2G-NBI组分别有44例（1.9%）和53例（2.3%; p=0.412）患者发现EGC。在事后分析中，第二次检查时检出病变的总体率为25%（n=36/145），组间无显著差异。WLI组（50/371个靶病变）和2G-NBI组（59/282个靶病变）可疑病变中EGC的PPV分别为13.5%和20.9%（p=0.015）。在高危患者中，初级内镜检测EGC的总体灵敏度仅为75%，应予以提高。与常规WLI相比，2G-NBI未增加EGC检出率。2G-NBI的PPV稍好的影响还有待进一步评估。UMIN000014503。
Early detection of gastric cancer has been the topic of major efforts in high prevalence areas. Whether advanced imaging methods, such as second-generation narrow band imaging (2G-NBI) can improve early detection, is unknown. This open-label, randomised, controlled tandem trial was conducted in 13 hospitals. Patients at increased risk for gastric cancer were randomly assigned to primary white light imaging (WLI) followed by secondary 2G-NBI (WLI group: n=2258) and primary 2G-NBI followed by secondary WLI (2G-NBI group: n=2265) performed by the same examiner. Suspected early gastric cancer (EGC) lesions in both groups were biopsied. Primary endpoint was the rate of EGC patients in the primary examination. The main secondary endpoint was the positive predictive value (PPV) for EGC in suspicious lesions detected (primary examination). EGCs were found in 44 (1.9%) and 53 (2.3%; p=0.412) patients in the WLI and 2G-NBI groups, respectively, during primary EGD. In a post hoc analysis, the overall rate of lesions detected at the second examination was 25% (n=36/145), with no significant differences between groups. PPV for EGC in suspicious lesions was 13.5% and 20.9% in the WLI (50/371 target lesions) and 2G-NBI groups (59/282 target lesions), respectively (p=0.015). The overall sensitivity of primary endoscopy for the detection of EGC in high-risk patients was only 75% and should be improved. 2G-NBI did not increase EGC detection rate over conventional WLI. The impact of a slightly better PPV of 2G-NBI has to be evaluated further. UMIN000014503.
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