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

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

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2022

Übergeordnetes Werk:	In: BMJ Open - BMJ Publishing Group, 2011, 12(2022), 9
Übergeordnetes Werk:	volume:12 ; year:2022 ; number:9

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1136/bmjopen-2021-059615

Katalog-ID:	DOAJ029249627

Internformat


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520			\|a 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.
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allfields	10.1136/bmjopen-2021-059615 doi (DE-627)DOAJ029249627 (DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52 DE-627 ger DE-627 rakwb eng Masahiro Umeda verfasserin aut Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study) 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Medicine R Akira Tanaka verfasserin aut Tadaaki Kirita verfasserin aut Souichi Yanamoto verfasserin aut Kenichiro Uchida verfasserin aut Seiji Asoda verfasserin aut Koji Kawaguchi verfasserin aut Mitsunobu Otsuru verfasserin aut Yoshiko Yamamura verfasserin aut Takumi Hasegawa verfasserin aut Shin-ichi Yamada verfasserin aut Yasuyuki Michi verfasserin aut Toru Inomata verfasserin aut Hideki Nakayama verfasserin aut Takeshi Nomura verfasserin aut Jingo Kusukawa verfasserin aut Nobuhiro Yamakawa verfasserin aut On Hasegawa verfasserin aut Michihiro Ueda verfasserin aut Yoshimasa Kitagawa verfasserin aut Akimitsu Hiraki verfasserin aut Toshihiro Hasegawa verfasserin aut Yoichi Ohiro verfasserin aut Wataru Kobayashi verfasserin aut Takanori Kobayashi verfasserin aut Mitsuyoshi Iino verfasserin aut Masayuki Fukuda verfasserin aut Naomi Ishibashi-Kanno verfasserin aut Reona Aijima verfasserin aut Kazuma Noguchi verfasserin aut Masaya Okura verfasserin aut Tsuyoshi Sugiura verfasserin aut Yukari Shintani verfasserin aut Kazuhiro Yagihara verfasserin aut Masashi Yamashiro verfasserin aut Yoshihide Ota verfasserin aut Akihiro Miyazaki verfasserin aut Akinori Takeshita verfasserin aut Hitoshi Kawamata verfasserin aut Iwabuchi Hiroshi verfasserin aut Hiroshi Kurita verfasserin aut In BMJ Open BMJ Publishing Group, 2011 12(2022), 9 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:12 year:2022 number:9 https://doi.org/10.1136/bmjopen-2021-059615 kostenfrei https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 kostenfrei https://bmjopen.bmj.com/content/12/9/e059615.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 9
spelling	10.1136/bmjopen-2021-059615 doi (DE-627)DOAJ029249627 (DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52 DE-627 ger DE-627 rakwb eng Masahiro Umeda verfasserin aut Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study) 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Medicine R Akira Tanaka verfasserin aut Tadaaki Kirita verfasserin aut Souichi Yanamoto verfasserin aut Kenichiro Uchida verfasserin aut Seiji Asoda verfasserin aut Koji Kawaguchi verfasserin aut Mitsunobu Otsuru verfasserin aut Yoshiko Yamamura verfasserin aut Takumi Hasegawa verfasserin aut Shin-ichi Yamada verfasserin aut Yasuyuki Michi verfasserin aut Toru Inomata verfasserin aut Hideki Nakayama verfasserin aut Takeshi Nomura verfasserin aut Jingo Kusukawa verfasserin aut Nobuhiro Yamakawa verfasserin aut On Hasegawa verfasserin aut Michihiro Ueda verfasserin aut Yoshimasa Kitagawa verfasserin aut Akimitsu Hiraki verfasserin aut Toshihiro Hasegawa verfasserin aut Yoichi Ohiro verfasserin aut Wataru Kobayashi verfasserin aut Takanori Kobayashi verfasserin aut Mitsuyoshi Iino verfasserin aut Masayuki Fukuda verfasserin aut Naomi Ishibashi-Kanno verfasserin aut Reona Aijima verfasserin aut Kazuma Noguchi verfasserin aut Masaya Okura verfasserin aut Tsuyoshi Sugiura verfasserin aut Yukari Shintani verfasserin aut Kazuhiro Yagihara verfasserin aut Masashi Yamashiro verfasserin aut Yoshihide Ota verfasserin aut Akihiro Miyazaki verfasserin aut Akinori Takeshita verfasserin aut Hitoshi Kawamata verfasserin aut Iwabuchi Hiroshi verfasserin aut Hiroshi Kurita verfasserin aut In BMJ Open BMJ Publishing Group, 2011 12(2022), 9 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:12 year:2022 number:9 https://doi.org/10.1136/bmjopen-2021-059615 kostenfrei https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 kostenfrei https://bmjopen.bmj.com/content/12/9/e059615.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 9
allfields_unstemmed	10.1136/bmjopen-2021-059615 doi (DE-627)DOAJ029249627 (DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52 DE-627 ger DE-627 rakwb eng Masahiro Umeda verfasserin aut Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study) 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Medicine R Akira Tanaka verfasserin aut Tadaaki Kirita verfasserin aut Souichi Yanamoto verfasserin aut Kenichiro Uchida verfasserin aut Seiji Asoda verfasserin aut Koji Kawaguchi verfasserin aut Mitsunobu Otsuru verfasserin aut Yoshiko Yamamura verfasserin aut Takumi Hasegawa verfasserin aut Shin-ichi Yamada verfasserin aut Yasuyuki Michi verfasserin aut Toru Inomata verfasserin aut Hideki Nakayama verfasserin aut Takeshi Nomura verfasserin aut Jingo Kusukawa verfasserin aut Nobuhiro Yamakawa verfasserin aut On Hasegawa verfasserin aut Michihiro Ueda verfasserin aut Yoshimasa Kitagawa verfasserin aut Akimitsu Hiraki verfasserin aut Toshihiro Hasegawa verfasserin aut Yoichi Ohiro verfasserin aut Wataru Kobayashi verfasserin aut Takanori Kobayashi verfasserin aut Mitsuyoshi Iino verfasserin aut Masayuki Fukuda verfasserin aut Naomi Ishibashi-Kanno verfasserin aut Reona Aijima verfasserin aut Kazuma Noguchi verfasserin aut Masaya Okura verfasserin aut Tsuyoshi Sugiura verfasserin aut Yukari Shintani verfasserin aut Kazuhiro Yagihara verfasserin aut Masashi Yamashiro verfasserin aut Yoshihide Ota verfasserin aut Akihiro Miyazaki verfasserin aut Akinori Takeshita verfasserin aut Hitoshi Kawamata verfasserin aut Iwabuchi Hiroshi verfasserin aut Hiroshi Kurita verfasserin aut In BMJ Open BMJ Publishing Group, 2011 12(2022), 9 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:12 year:2022 number:9 https://doi.org/10.1136/bmjopen-2021-059615 kostenfrei https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 kostenfrei https://bmjopen.bmj.com/content/12/9/e059615.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 9
allfieldsGer	10.1136/bmjopen-2021-059615 doi (DE-627)DOAJ029249627 (DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52 DE-627 ger DE-627 rakwb eng Masahiro Umeda verfasserin aut Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study) 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Medicine R Akira Tanaka verfasserin aut Tadaaki Kirita verfasserin aut Souichi Yanamoto verfasserin aut Kenichiro Uchida verfasserin aut Seiji Asoda verfasserin aut Koji Kawaguchi verfasserin aut Mitsunobu Otsuru verfasserin aut Yoshiko Yamamura verfasserin aut Takumi Hasegawa verfasserin aut Shin-ichi Yamada verfasserin aut Yasuyuki Michi verfasserin aut Toru Inomata verfasserin aut Hideki Nakayama verfasserin aut Takeshi Nomura verfasserin aut Jingo Kusukawa verfasserin aut Nobuhiro Yamakawa verfasserin aut On Hasegawa verfasserin aut Michihiro Ueda verfasserin aut Yoshimasa Kitagawa verfasserin aut Akimitsu Hiraki verfasserin aut Toshihiro Hasegawa verfasserin aut Yoichi Ohiro verfasserin aut Wataru Kobayashi verfasserin aut Takanori Kobayashi verfasserin aut Mitsuyoshi Iino verfasserin aut Masayuki Fukuda verfasserin aut Naomi Ishibashi-Kanno verfasserin aut Reona Aijima verfasserin aut Kazuma Noguchi verfasserin aut Masaya Okura verfasserin aut Tsuyoshi Sugiura verfasserin aut Yukari Shintani verfasserin aut Kazuhiro Yagihara verfasserin aut Masashi Yamashiro verfasserin aut Yoshihide Ota verfasserin aut Akihiro Miyazaki verfasserin aut Akinori Takeshita verfasserin aut Hitoshi Kawamata verfasserin aut Iwabuchi Hiroshi verfasserin aut Hiroshi Kurita verfasserin aut In BMJ Open BMJ Publishing Group, 2011 12(2022), 9 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:12 year:2022 number:9 https://doi.org/10.1136/bmjopen-2021-059615 kostenfrei https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 kostenfrei https://bmjopen.bmj.com/content/12/9/e059615.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 9
allfieldsSound	10.1136/bmjopen-2021-059615 doi (DE-627)DOAJ029249627 (DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52 DE-627 ger DE-627 rakwb eng Masahiro Umeda verfasserin aut Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study) 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Medicine R Akira Tanaka verfasserin aut Tadaaki Kirita verfasserin aut Souichi Yanamoto verfasserin aut Kenichiro Uchida verfasserin aut Seiji Asoda verfasserin aut Koji Kawaguchi verfasserin aut Mitsunobu Otsuru verfasserin aut Yoshiko Yamamura verfasserin aut Takumi Hasegawa verfasserin aut Shin-ichi Yamada verfasserin aut Yasuyuki Michi verfasserin aut Toru Inomata verfasserin aut Hideki Nakayama verfasserin aut Takeshi Nomura verfasserin aut Jingo Kusukawa verfasserin aut Nobuhiro Yamakawa verfasserin aut On Hasegawa verfasserin aut Michihiro Ueda verfasserin aut Yoshimasa Kitagawa verfasserin aut Akimitsu Hiraki verfasserin aut Toshihiro Hasegawa verfasserin aut Yoichi Ohiro verfasserin aut Wataru Kobayashi verfasserin aut Takanori Kobayashi verfasserin aut Mitsuyoshi Iino verfasserin aut Masayuki Fukuda verfasserin aut Naomi Ishibashi-Kanno verfasserin aut Reona Aijima verfasserin aut Kazuma Noguchi verfasserin aut Masaya Okura verfasserin aut Tsuyoshi Sugiura verfasserin aut Yukari Shintani verfasserin aut Kazuhiro Yagihara verfasserin aut Masashi Yamashiro verfasserin aut Yoshihide Ota verfasserin aut Akihiro Miyazaki verfasserin aut Akinori Takeshita verfasserin aut Hitoshi Kawamata verfasserin aut Iwabuchi Hiroshi verfasserin aut Hiroshi Kurita verfasserin aut In BMJ Open BMJ Publishing Group, 2011 12(2022), 9 (DE-627)654747075 (DE-600)2599832-8 20446055 nnns volume:12 year:2022 number:9 https://doi.org/10.1136/bmjopen-2021-059615 kostenfrei https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 kostenfrei https://bmjopen.bmj.com/content/12/9/e059615.full kostenfrei https://doaj.org/toc/2044-6055 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_375 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 12 2022 9
language	English
source	In BMJ Open 12(2022), 9 volume:12 year:2022 number:9
sourceStr	In BMJ Open 12(2022), 9 volume:12 year:2022 number:9
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Medicine R
isfreeaccess_bool	true
container_title	BMJ Open
authorswithroles_txt_mv	Masahiro Umeda @@aut@@ Akira Tanaka @@aut@@ Tadaaki Kirita @@aut@@ Souichi Yanamoto @@aut@@ Kenichiro Uchida @@aut@@ Seiji Asoda @@aut@@ Koji Kawaguchi @@aut@@ Mitsunobu Otsuru @@aut@@ Yoshiko Yamamura @@aut@@ Takumi Hasegawa @@aut@@ Shin-ichi Yamada @@aut@@ Yasuyuki Michi @@aut@@ Toru Inomata @@aut@@ Hideki Nakayama @@aut@@ Takeshi Nomura @@aut@@ Jingo Kusukawa @@aut@@ Nobuhiro Yamakawa @@aut@@ On Hasegawa @@aut@@ Michihiro Ueda @@aut@@ Yoshimasa Kitagawa @@aut@@ Akimitsu Hiraki @@aut@@ Toshihiro Hasegawa @@aut@@ Yoichi Ohiro @@aut@@ Wataru Kobayashi @@aut@@ Takanori Kobayashi @@aut@@ Mitsuyoshi Iino @@aut@@ Masayuki Fukuda @@aut@@ Naomi Ishibashi-Kanno @@aut@@ Reona Aijima @@aut@@ Kazuma Noguchi @@aut@@ Masaya Okura @@aut@@ Tsuyoshi Sugiura @@aut@@ Yukari Shintani @@aut@@ Kazuhiro Yagihara @@aut@@ Masashi Yamashiro @@aut@@ Yoshihide Ota @@aut@@ Akihiro Miyazaki @@aut@@ Akinori Takeshita @@aut@@ Hitoshi Kawamata @@aut@@ Iwabuchi Hiroshi @@aut@@ Hiroshi Kurita @@aut@@
publishDateDaySort_date	2022-01-01T00:00:00Z
hierarchy_top_id	654747075
id	DOAJ029249627
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ029249627</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230307133913.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230226s2022 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1136/bmjopen-2021-059615</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ029249627</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJ89e3ab15286b423db003c82d6abe4c52</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Masahiro Umeda</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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.</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Medicine</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">R</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Akira Tanaka</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Tadaaki Kirita</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Souichi Yanamoto</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="0" ind2=" "><subfield code="a">Kenichiro Uchida</subfield><subfield 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author	Masahiro Umeda
spellingShingle	Masahiro Umeda misc Medicine misc R 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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topic_title	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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title	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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title_full	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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author_browse	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
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title_sort	protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (end-tc study)
title_auth	Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)
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.
abstractGer	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.
abstract_unstemmed	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.
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title_short	Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)
url	https://doi.org/10.1136/bmjopen-2021-059615 https://doaj.org/article/89e3ab15286b423db003c82d6abe4c52 https://bmjopen.bmj.com/content/12/9/e059615.full https://doaj.org/toc/2044-6055
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author2	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
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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. 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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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