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Original research
Early gastric cancer detection in high-risk patients: a multicentre randomised controlled trial on the effect of second-generation narrow band imaging
  1. Naohiro Yoshida1,
  2. Hisashi Doyama1,
  3. Tomonori Yano2,
  4. Takahiro Horimatsu3,
  5. Noriya Uedo4,
  6. Yoshinobu Yamamoto5,
  7. Naomi Kakushima6,
  8. Hiromitsu Kanzaki7,
  9. Shinichiro Hori8,
  10. Kenshi Yao9,
  11. Ichiro Oda10,
  12. Chikatoshi Katada11,
  13. Chizu Yokoi12,
  14. Ken Ohata13,
  15. Kenichi Yoshimura14,
  16. Hideki Ishikawa15,
  17. Manabu Muto3
  1. 1Department of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan
  2. 2Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan
  3. 3Department of Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  4. 4Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan
  5. 5Department of Gastrointestinal Oncology, Hyogo Cancer Center, Hyogo, Japan
  6. 6Department of Endoscopy, Shizuoka Cancer Center, Shizuoka, Japan
  7. 7Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan
  8. 8Department of Endoscopy, National Hospital Organization Shikoku Cancer Center, Ehime, Japan
  9. 9Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan
  10. 10Department of Endoscopy, National Cancer Center Hospital, Tokyo, Japan
  11. 11Department of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan
  12. 12Department of Gastroenterology, National Center for Global Health and Medicine, Tokyo, Japan
  13. 13Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan
  14. 14Innovative Clinical Research Center, Kanazawa University Hospital, Ishikawa, Japan
  15. 15Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan
  1. Correspondence to Dr Manabu Muto, Therapeutic Oncology, Graduate School of Medicine, Kyoto University, Sakyo, Kyoto, Japan; mmuto{at}kuhp.kyoto-u.ac.jp

Abstract

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.

  • gastric cancer
  • endoscopy
  • surveillance
  • screening
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Footnotes

  • Contributors NY: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; final approval of the article; and study supervision. MM: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; final approval of the article; study supervision and obtaining of funding. HD and NU: study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; and final approval of the article. TY, TH, YY, NK, HK, SH, KensY, IO, CK, CY, and KO: study concept and design; acquisition of data; analysis and interpretation of data; and final approval of the article. KeniY and HI: study concept and design; analysis and interpretation of data; statistical analysis; and final approval of the article.

  • Funding The Olympus Corporation provided partial funding for this study. This study was funded by joint research funds supplied by Kyoto University and the Olympus Corporation. Conflicts of interest exist between Kyoto University, but not the other participating institutions, and the Olympus Corporation.

  • Disclaimer The funding source had no role in the conduct of the study; the collection, management, analysis or interpretation of the data; or in the preparation, review or approval of the manuscript.

  • Competing interests MM received grants from Olympus during the study period. TY received personal fees and non-financial support from Olympus, outside this study.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. The data that support the findings of this study have been deposited in UMIN (https://www.umin.ac.jp/icdr/index.html), and the data are available from the corresponding author, MM, on reasonable request.

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