Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

Souichi Yanamoto; Yasuyuki Michi; Mitsunobu Otsuru; Toru Inomata; Hideki Nakayama; Takeshi Nomura; Takumi Hasegawa; Yoshiko Yamamura; Shin-Ichi Yamada; Jingo Kusukawa; Nobuhiro Yamakawa; On Hasegawa; Michihiro Ueda; Yoshimasa Kitagawa; Akimitsu Hiraki; Toshihiro Hasegawa; Yoichi Ohiro; Wataru Kobayashi; Seiji Asoda; Takanori Kobayashi; Mitsuyoshi Iino; Masayuki Fukuda; Naomi Ishibashi-Kanno; Koji Kawaguchi; Reona Aijima; Kazuma Noguchi; Masaya Okura; Akira Tanaka; Tsuyoshi Sugiura; Yukari Shintani; Kazuhiro Yagihara; Masashi Yamashiro; Yoshihide Ota; Akihiro Miyazaki; Akinori Takeshita; Hitoshi Kawamata; Iwabuchi Hiroshi; Kenichiro Uchida; Masahiro Umeda; Hiroshi Kurita; Tadaaki Kirita

doi:10.1136/bmjopen-2021-059615

Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

BMJ Open. 2022 Sep 13;12(9):e059615. doi: 10.1136/bmjopen-2021-059615.

Authors

Souichi Yanamoto¹, Yasuyuki Michi², Mitsunobu Otsuru³, Toru Inomata⁴, Hideki Nakayama⁵, Takeshi Nomura⁶, Takumi Hasegawa⁷, Yoshiko Yamamura⁸, Shin-Ichi Yamada⁹, Jingo Kusukawa¹⁰, Nobuhiro Yamakawa¹¹, On Hasegawa¹², Michihiro Ueda¹³, Yoshimasa Kitagawa¹⁴, Akimitsu Hiraki¹⁵, Toshihiro Hasegawa¹⁶, Yoichi Ohiro¹⁷, Wataru Kobayashi¹⁸, Seiji Asoda¹⁹, Takanori Kobayashi²⁰, Mitsuyoshi Iino²¹, Masayuki Fukuda²², Naomi Ishibashi-Kanno²³, Koji Kawaguchi²⁴, Reona Aijima²⁵, Kazuma Noguchi²⁶, Masaya Okura²⁷, Akira Tanaka²⁸, Tsuyoshi Sugiura²⁹, Yukari Shintani³⁰, Kazuhiro Yagihara³¹, Masashi Yamashiro³², Yoshihide Ota³³, Akihiro Miyazaki³⁴, Akinori Takeshita³⁵, Hitoshi Kawamata³⁶, Iwabuchi Hiroshi³⁷, Kenichiro Uchida³⁸, Masahiro Umeda³, Hiroshi Kurita⁹, Tadaaki Kirita¹¹

Affiliations

¹ Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan souichi.yanamoto@gmail.com.
² Department of Oral and Maxillofacial Surgical Oncology, Tokyo Medical and Dental University, Tokyo, Japan.
³ Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
⁴ Department of Oral and Maxillofacial Surgery, The Nippon Dental University, Tokyo, Japan.
⁵ Department of Oral and Maxillofacial Surgery, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
⁶ Department of Oral Oncology, Oral and Maxillofacial Surgery, Tokyo Dental College, Tokyo, Japan.
⁷ Department of Oral and Maxillofacial Surgery, Kobe University, Kobe, Japan.
⁸ Department of Oral Surgery, Tokushima University, Tokushima, Japan.
⁹ Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, Matsumoto, Nagano, Japan.
¹⁰ Dental and Oral Medical Center, Kurume University School of Medicine, Kurume, Japan.
¹¹ Department of Oral and Maxillofacial Surgery, Nara Medical University, Kashihara, Nara, Japan.
¹² Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Tokyo Medical University, Tokyo, Japan.
¹³ Department of Oral Surgical Oncology, National Hospital Organisation Hokkaido Cancer Center, Sapporo, Japan.
¹⁴ Oral Diagnosis and Medicine, Hokkaido University, Sapporo, Japan.
¹⁵ Department of Oral and Maxillofacial Surgery, Fukuoka Dental College, Fukuoka, Japan.
¹⁶ Department of Oral and Maxillofacial Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
¹⁷ Department of Oral and Maxillofacial Surgery, Hokkaido University, Sapporo, Japan.
¹⁸ Department of Oral and Maxillofacial surgery, Hirosaki University, Hirosaki, Aomori, Japan.
¹⁹ Department of Dentistry and Oral Surgery, Keio University School of Medicine, Tokyo, Japan.
²⁰ Department of Dentistry and Oral Surgery, Nagaoka Red Cross Hospital, Nagaoka, Japan.
²¹ Department of Dentistry, Yamagata University, Yamagata, Japan.
²² Department of Dentistry and Oral Surgery, Akita University, Akita, Japan.
²³ Department of Oral and Maxillofacial Surgery, Institute of Clinical Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
²⁴ Department of Oral and Maxillofacial Surgery, Tsurumi University, Yokohama, Japan.
²⁵ Department of Oral and Maxillofacial Surgery, Saga University, Saga, Japan.
²⁶ Department of Oral and Maxillofacial Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
²⁷ Department of Dentistry and Oral Surgery, Saiseikai Matsusaka General Hospital, Matsuzaka, Mie, Japan.
²⁸ Department of Oral and Maxillofacial Surgery, The Nippon Dental University, Niigata, Japan.
²⁹ Department of Maxillofacial Diagnostic and Surgical Science, Kagoshima University, Kagoshima, Japan.
³⁰ Department of Oral and Maxillofacial Surgery, Wakayama Medical University, Wakayama, Japan.
³¹ Department of Oral Surgery, Saitama Cancer Center, Saitama, Japan.
³² Dentistry and Oral Surgery, NTT Medical Center Tokyo, Tokyo, Japan.
³³ Department of Oral and Maxillofacial Surgery, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
³⁴ Department of Oral Surgery, Sapporo Medical University, Sapporo, Japan.
³⁵ Department of Oral and Maxillofacial Surgery II, Osaka University Graduate School of Dentistry, Suita, Osaka, Japan.
³⁶ Department of Oral and Maxillofacial Surgery, Dokkyo Medical University, Shimotsuga-gun, Tochigi, Japan.
³⁷ Kanagawa Dental University, Yokosuka, Kanagawa, Japan.
³⁸ Department of Oral and Maxillofacial Surgery, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan.

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.

Keywords: Head & neck surgery; ONCOLOGY; ORAL & MAXILLOFACIAL SURGERY.

Publication types

Multicenter Study
Observational Study
Research Support, Non-U.S. Gov't

MeSH terms

Carcinoma, Squamous Cell*
Head and Neck Neoplasms* / surgery
Humans
Neck Dissection / methods
Neoplasm Recurrence, Local / surgery
Prospective Studies
Quality of Life
Squamous Cell Carcinoma of Head and Neck / surgery
Tongue Neoplasms* / pathology
Tongue Neoplasms* / surgery