Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study).
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Yanamoto Souichi, Michi Yasuyuki, Otsuru Mitsunobu, Inomata Toru, Nakayama Hideki, Nomura Takeshi, Hasegawa Takumi, Yamamura Yoshiko, Yamada Shin-Ichi, Kusukawa Jingo, Yamakawa Nobuhiro, Hasegawa On, Ueda Michihiro, Kitagawa Yoshimasa, Hiraki Akimitsu, Hasegawa Toshihiro, Ohiro Yoichi, Kobayashi Wataru, Asoda Seiji, Kobayashi Takanori, Iino Mitsuyoshi, Fukuda Masayuki, Ishibashi-Kanno Naomi, Kawaguchi Koji, Aijima Reona, Noguchi Kazuma, Okura Masaya, Tanaka Akira, Sugiura Tsuyoshi, Shintani Yukari, Yagihara Kazuhiro, Yamashiro Masashi, Ota Yoshihide, Miyazaki Akihiro, Takeshita Akinori, Kawamata Hitoshi, Hiroshi Iwabuchi, Uchida Kenichiro, Umeda Masahiro, Kurita Hiroshi, Kirita Tadaaki
Аннотация
METHODS AND ANALYSIS: This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoints are 3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias.
ETHICS AND DISSEMINATION: This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the corresponding author on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER: UMIN000027875.