PT  - JOURNAL ARTICLE
AU  - Naohiro Yoshida
AU  - Hisashi Doyama
AU  - Tomonori Yano
AU  - Takahiro Horimatsu
AU  - Noriya Uedo
AU  - Yoshinobu Yamamoto
AU  - Naomi Kakushima
AU  - Hiromitsu Kanzaki
AU  - Shinichiro Hori
AU  - Kenshi Yao
AU  - Ichiro Oda
AU  - Chikatoshi Katada
AU  - Chizu Yokoi
AU  - Ken Ohata
AU  - Kenichi Yoshimura
AU  - Hideki Ishikawa
AU  - Manabu Muto
TI  - Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging
AID  - 10.1136/gutjnl-2019-319631
DP  - 2021 Jan 01
TA  - Gut
PG  - 67--75
VI  - 70
IP  - 1
4099  - http://gut.bmj.com/content/70/1/67.short
4100  - http://gut.bmj.com/content/70/1/67.full
SO  - Gut2021 Jan 01; 70
AB  - Objective 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.Design 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).Results 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).Conclusion 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.Trial registration number UMIN000014503.