@article{oai:nagasaki-u.repo.nii.ac.jp:00027638,
 author = {Yanamoto, Souichi and Michi, Yasuyuki and Otsuru, Mitsunobu and Inomata, Toru and Nakayama, Hideki and Nomura, Takeshi and Hasegawa, Takumi and Yamamura, Yoshiko and Yamada, Shin-ichi and Kusukawa, Jingo and Yamakawa, Nobuhiro and Hasegawa, On and Ueda, Michihiro and Kitagawa, Yoshimasa and Hiraki, Akimitsu and Hasegawa, Toshihiro and Ohiro, Yoichi and Kobayashi, Wataru and Asoda, Seiji and Kobayashi, Takanori and Iino, Mitsuyoshi and Fukuda, Masayuki and Ishibashi-Kanno, Naomi and Kawaguchi, Koji and Aijima, Reona and Noguchi, Kazuma and Okura, Masaya and Tanaka, Akira and Sugiura, Tsuyoshi and Shintani, Yukari and Yagihara, Kazuhiro and Yamashiro, Masashi and Ota, Yoshihide and Miyazaki, Akihiro and Takeshita, Akinori and Kawamata, Hitoshi and Hiroshi, Iwabuchi and Uchida, Kenichiro and Umeda, Masahiro and Kurita, Hiroshi and Kirita, Tadaaki},
 issue = {9},
 journal = {BMJ Open},
 month = {Sep},
 note = {Introduction In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis is
suspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCC
remains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC.
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., BMJ open, 12 (9), art. no. e059615; 2022},
 title = {Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)},
 volume = {12},
 year = {2022}
}