Nishimura Goshi, Sano Daisuke, Yabuki Kenichiro, Arai Yasuhiro, Chiba Yoshihiro, Tanabe Teruhiko, Oridate Nobuhiko
Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.
JMIR Res Protoc. 2017 Dec 5;6(12):e235. doi: 10.2196/resprot.8907.
Transoral videolaryngoscopic surgery (TOVS) has been widely applied for early T stage head and neck cancer. The resection is performed with a minimum safety margin for function preservation under a limited surgical field of view, making it difficult to be certain of complete resection.
Our aim is the evaluation of the completeness of resection by initial TOVS resection, and the possibility of primary control by TOVS alone, allowing for repeat procedures for function preserving treatment in early T stage laryngeal, oropharyngeal, and hypopharyngeal cancer patients.
Patients are treated by TOVS for the primary site with or without neck dissection. Patients are divided in two groups based on the results of the pathological evaluation of the surgical specimen; the control group in which the resection is considered to be complete, and the intervention (second-look procedure) group in which incomplete tumor resection is suspected. The predictive factors for the possibility of complete resection by TOVS will then be analyzed.
Patient enrollment started on January 1, 2014, and closed on March 31, 2016, with 54 patients. The control group consists of 27 patients, the intervention group is 21 patients, and 6 patients were excluded. There were no clinical differences between the control and intervention groups. The observation period will end on December 31, 2018.
TOVS has potential for both definitive resection and function preservation with minimal invasiveness. Identifying the limitations of TOVS is beneficial to ensure accurate treatment selection in early T stage head and neck cancer patients.
UMIN Clinical Trials Registry: UMIN000012485; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000014472 (Archived by WebCite at http://www.webcitation.org/6v1b741Iw).
经口视频喉镜手术（TOVS）已广泛应用于早期T分期的头颈癌。手术在有限的手术视野下进行，以最小安全切缘进行切除以保留功能，这使得难以确定是否完全切除。
我们的目的是评估初次TOVS切除的切除完整性，以及仅通过TOVS实现原发灶控制的可能性，从而为早期T分期喉癌、口咽癌和下咽癌患者进行保留功能的重复治疗。
患者接受TOVS治疗原发灶，可联合或不联合颈部清扫。根据手术标本的病理评估结果将患者分为两组；切除被认为完整的对照组，以及怀疑肿瘤切除不完全的干预（二次探查手术）组。然后分析TOVS完全切除可能性的预测因素。
患者入组于2014年1月1日开始，2016年3月31日结束，共54例患者。对照组27例患者，干预组21例患者，6例患者被排除。对照组和干预组之间无临床差异。观察期将于2018年12月31日结束。
TOVS具有微创性的根治性切除和功能保留的潜力。明确TOVS的局限性有助于确保早期T分期头颈癌患者的准确治疗选择。
UMIN临床试验注册中心：UMIN000012485；https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014472（由WebCite存档于http://www.webcitation.org/6v1b741Iw）
