Shoko Ono1, Kenro Kawada2, Osamu Dohi3, Shinji Kitamura4, Tomoyuki Koike5, Shinichiro Hori6, Hiromitsu Kanzaki7, Takahisa Murao8, Nobuaki Yagi9, Fumisato Sasaki10, Keiichi Hashiguchi11, Shiro Oka12, Kazuhiro Katada13, Ryo Shimoda14, Kazuhiro Mizukami15, Mitsuhiko Suehiro16, Toshihisa Takeuchi17, Shinichi Katsuki18, Momoko Tsuda1, Yuji Naito3, Tatsuyuki Kawano19, Ken Haruma16, Hideki Ishikawa20, Keita Mori21, Mototsugu Kato22. 1. Hokkaido University Hospital, Sapporo, Japan (S.O., M.T.). 2. Tokyo Medical and Dental University, Tokyo, Japan (K.K.). 3. Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan (O.D., Y.N.). 4. Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan (S.K.). 5. Tohoku University Graduate School of Medicine, Sendai, Japan (T.K.). 6. National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan (S.H.). 7. Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan (H.K.). 8. Kawasaki Medical School, Okayama, Japan (T.M.). 9. Asahi University Hospital, Gifu, Japan (N.Y.). 10. Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan (F.S.). 11. Nagasaki University Hospital, Nagasaki, Japan (K.H.). 12. Hiroshima University Hospital, Hiroshima, Japan (S.O.). 13. North Medical Center, Kyoto Prefectural University of Medicine, Kyoto, Japan (K.K.). 14. Saga University, Saga, Japan (R.S.). 15. Oita University, Oita, Japan (K.M.). 16. Kawasaki Medical School General Medical Center, Okayama, Japan (M.S., K.H.). 17. Osaka Medical College, Osaka, Japan (T.T.). 18. Otaru Ekisaikai Hospital, Otaru, Japan (S.K.). 19. Soka Municipal Hospital, Soka, Japan (T.K.). 20. Kyoto Prefectural University of Medicine, Osaka, Japan (H.I.). 21. Shizuoka Cancer Center, Shizuoka, Japan (K.M.). 22. National Hospital Organization Hakodate National Hospital, Hakodate, Japan (M.K.).
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; P = 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.
RCT Entities:
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; P = 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.