• Ann. Intern. Med. · Jan 2021

    Randomized Controlled Trial Multicenter Study

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

    • Shoko Ono, Kenro Kawada, Osamu Dohi, Shinji Kitamura, Tomoyuki Koike, Shinichiro Hori, Hiromitsu Kanzaki, Takahisa Murao, Nobuaki Yagi, Fumisato Sasaki, Keiichi Hashiguchi, Shiro Oka, Kazuhiro Katada, Ryo Shimoda, Kazuhiro Mizukami, Mitsuhiko Suehiro, Toshihisa Takeuchi, Shinichi Katsuki, Momoko Tsuda, Yuji Naito, Tatsuyuki Kawano, Ken Haruma, Hideki Ishikawa, Keita Mori, Mototsugu Kato, and LCI-FIND Trial Group.
    • Hokkaido University Hospital, Sapporo, Japan (S.O., M.T.).
    • Ann. Intern. Med. 2021 Jan 1; 174 (1): 18-24.

    BackgroundLinked color imaging (LCI) is a new image-enhanced endoscopy technique that allows users to recognize slight differences in mucosal color.ObjectiveTo compare the performance of LCI with white light imaging (WLI) in detecting neoplastic lesions in the upper gastrointestinal tract.DesignA controlled, multicenter trial with randomization using minimization. (University Hospital Medical Information Network Clinical Trials Registry: UMIN000023863).Setting16 university hospitals and 3 tertiary care hospitals in Japan.Patients1502 patients with known previous or current cancer of the gastrointestinal tract and undergoing surveillance for gastrointestinal cancer.InterventionWLI followed by LCI examination (WLI group) or LCI followed by WLI examination (LCI group).MeasurementsDiagnosis 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).Results752 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]).LimitationEndoscopists were not blinded.ConclusionLCI is more effective than WLI for detecting neoplastic lesions in the pharynx, esophagus, and stomach.Primary Funding SourceFujifilm Corporation.

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