BMJ Open (Sep 2022)
Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)
- Masahiro Umeda,
- Akira Tanaka,
- Tadaaki Kirita,
- Souichi Yanamoto,
- Kenichiro Uchida,
- Seiji Asoda,
- Koji Kawaguchi,
- Mitsunobu Otsuru,
- Yoshiko Yamamura,
- Takumi Hasegawa,
- Shin-ichi Yamada,
- Yasuyuki Michi,
- Toru Inomata,
- Hideki Nakayama,
- Takeshi Nomura,
- Jingo Kusukawa,
- Nobuhiro Yamakawa,
- On Hasegawa,
- Michihiro Ueda,
- Yoshimasa Kitagawa,
- Akimitsu Hiraki,
- Toshihiro Hasegawa,
- Yoichi Ohiro,
- Wataru Kobayashi,
- Takanori Kobayashi,
- Mitsuyoshi Iino,
- Masayuki Fukuda,
- Naomi Ishibashi-Kanno,
- Reona Aijima,
- Kazuma Noguchi,
- Masaya Okura,
- Tsuyoshi Sugiura,
- Yukari Shintani,
- Kazuhiro Yagihara,
- Masashi Yamashiro,
- Yoshihide Ota,
- Akihiro Miyazaki,
- Akinori Takeshita,
- Hitoshi Kawamata,
- Iwabuchi Hiroshi,
- Hiroshi Kurita
Affiliations
- Masahiro Umeda
- Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
- Akira Tanaka
- Department of Oral and Maxillofacial Surgery, The Nippon Dental University, Niigata, Japan
- Tadaaki Kirita
- Department of Oral and Maxillofacial Surgery, Nara Medical University, Kashihara, Nara, Japan
- Souichi Yanamoto
- Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
- Kenichiro Uchida
- Department of Oral and Maxillofacial Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan
- Seiji Asoda
- Department of Dentistry and Oral Surgery, Keio University School of Medicine, Tokyo, Japan
- Koji Kawaguchi
- Department of Oral and Maxillofacial Surgery, Tsurumi University, Yokohama, Japan
- Mitsunobu Otsuru
- Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
- Yoshiko Yamamura
- Department of Oral Surgery, Tokushima University, Tokushima, Japan
- Takumi Hasegawa
- Department of Oral and Maxillofacial Surgery, Kobe University, Kobe, Japan
- Shin-ichi Yamada
- Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan
- Yasuyuki Michi
- Department of Oral and Maxillofacial Surgical Oncology, Tokyo Medical and Dental University, Tokyo, Japan
- Toru Inomata
- Department of Oral and Maxillofacial Surgery, The Nippon Dental University, Tokyo, Japan
- Hideki Nakayama
- Department of Oral and Maxillofacial Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan
- Takeshi Nomura
- Department of Oral Oncology, Oral and Maxillofacial Surgery, Tokyo Dental College, Tokyo, Japan
- Jingo Kusukawa
- Dental and Oral Medical Center, Kurume University School of Medicine, Kurume, Japan
- Nobuhiro Yamakawa
- Department of Oral and Maxillofacial Surgery, Nara Medical University, Kashihara, Nara, Japan
- On Hasegawa
- Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Tokyo Medical University, Tokyo, Japan
- Michihiro Ueda
- Department of Oral Surgical Oncology, National Hospital Organisation Hokkaido Cancer Center, Sapporo, Japan
- Yoshimasa Kitagawa
- Oral Diagnosis and Medicine, Hokkaido University, Sapporo, Japan
- Akimitsu Hiraki
- Department of Oral and Maxillofacial Surgery, Fukuoka Dental College, Fukuoka, Japan
- Toshihiro Hasegawa
- Department of Oral and Maxillofacial Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan
- Yoichi Ohiro
- Department of Oral and Maxillofacial Surgery, Hokkaido University, Sapporo, Japan
- Wataru Kobayashi
- Department of Oral and Maxillofacial surgery, Hirosaki University, Hirosaki, Aomori, Japan
- Takanori Kobayashi
- Department of Dentistry and Oral Surgery, Nagaoka Red Cross Hospital, Nagaoka, Japan
- Mitsuyoshi Iino
- Department of Dentistry, Yamagata University, Yamagata, Japan
- Masayuki Fukuda
- Department of Dentistry and Oral Surgery, Akita University, Akita, Japan
- Naomi Ishibashi-Kanno
- Department of Oral and Maxillofacial Surgery, Institute of Clinical Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
- Reona Aijima
- Department of Oral and Maxillofacial Surgery, Saga University, Saga, Japan
- Kazuma Noguchi
- Department of Oral and Maxillofacial Surgery, Hyogo College of Medicine, Nishinomiya, Japan
- Masaya Okura
- Department of Dentistry and Oral Surgery, Saiseikai Matsusaka General Hospital, Matsuzaka, Mie, Japan
- Tsuyoshi Sugiura
- Department of Maxillofacial Diagnostic and Surgical Science, Kagoshima University, Kagoshima, Japan
- Yukari Shintani
- Department of Oral and Maxillofacial Surgery, Wakayama Medical University, Wakayama, Japan
- Kazuhiro Yagihara
- Department of Oral Surgery, Saitama Cancer Center, Saitama, Japan
- Masashi Yamashiro
- Dentistry and Oral Surgery, NTT Medical Center Tokyo, Tokyo, Japan
- Yoshihide Ota
- Department of Oral and Maxillofacial Surgery, Tokai University School of Medicine, Isehara, Kanagawa, Japan
- Akihiro Miyazaki
- Department of Oral Surgery, Sapporo Medical University, Sapporo, Japan
- Akinori Takeshita
- Department of Oral and Maxillofacial Surgery II, Osaka University Graduate School of Dentistry, Suita, Osaka, Japan
- Hitoshi Kawamata
- Department of Oral and Maxillofacial Surgery, Dokkyo Medical University, Shimotsuga-gun, Tochigi, Japan
- Iwabuchi Hiroshi
- Kanagawa Dental University, Yokosuka, Kanagawa, Japan
- Hiroshi Kurita
- Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan
- DOI
- https://doi.org/10.1136/bmjopen-2021-059615
- Journal volume & issue
-
Vol. 12,
no. 9
Abstract
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.Trial registration number UMIN000027875.
