• Annals of surgery · Oct 2023

    Randomized Controlled Trial

    Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial.

    • Jun Watanabe, Ichiro Takemasa, Masanori Kotake, Shingo Noura, Kei Kimura, Hirokazu Suwa, Mitsuyoshi Tei, Yoshinao Takano, Koji Munakata, Shuichiro Matoba, Sigeru Yamagishi, Masayoshi Yasui, Takeshi Kato, Atsushi Ishibe, Manabu Shiozawa, Yoshiyuki Ishii, Taichi Yabuno, Toshikatsu Nitta, Shuji Saito, Yusuke Saigusa, Masahiko Watanabe, and EssentiAL Trial Group.
    • Department of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Minami-ku, Yokohama, Japan.
    • Ann. Surg. 2023 Oct 1; 278 (4): e688e694e688-e694.

    ObjectiveThe aim of the present randomized controlled trial was to evaluate the superiority of indocyanine green fluorescence imaging (ICG-FI) in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery.BackgroundThe role of ICG-FI in anastomotic leakage in minimally invasive rectal cancer surgery is controversial according to the published literature.MethodsThis randomized, open-label, phase 3, trial was performed at 41 hospitals in Japan. Patients with clinically stage 0-III rectal carcinoma less than 12 cm from the anal verge, scheduled for minimally invasive sphincter-preserving surgery were preoperatively randomly assigned to receive a blood flow evaluation by ICG-FI (ICG+ group) or no blood flow evaluation by ICG-FI (ICG- group). The primary endpoint was the anastomotic leakage rate (grade A+B+C, expected reduction rate of 6%) analyzed in the modified intention-to-treat population.ResultsBetween December 2018 and February 2021, a total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG- group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG- group (11.8%) (relative risk, 0.645; 95% confidence interval 0.422-0.987; P =0.041). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG- group ( P =0.044), and the respective reoperation rates were 0.5% and 2.4% ( P =0.021).ConclusionsAlthough the actual reduction rate of anastomotic leakage in the ICG+ group was lower than the expected reduction rate and ICG-FI was not superior to white light, ICG-FI significantly reduced the anastomotic leakage rate by 4.2%.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.

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