ChiCTR2200055608 版本V1.1 版本创建时间2022/01/24 12:31:08 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2200055608 

最近更新日期：

Date of Last Refreshed on：

2022-01-14 22:32:29 

注册时间：

Date of Registration：

2022-01-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

请与我们联系上传伦理审批文件。 颏下-颌下颌骨裂开进路舌鳞癌根治同期游离皮瓣修复的单中心、前瞻性、随机、对照临床研究

Public title：

A single-center, prospective, randomized, controlled clinical study of tongue squamous cell carcinoma radical surgery and simultaneous free flap repair in the submental-mandibular dehiscence approach

注册题目简写：

颏下-颌下颌骨裂开进路舌鳞癌根治同期游离皮瓣修复研究

English Acronym：

Study on the simultaneous free skin flap repair for tongue squamous cell carcinoma with the submental-mandibular dehiscence approach

研究课题的正式科学名称：

颏下-颌下颌骨裂开进路舌鳞癌根治同期游离皮瓣修复的单中心、前瞻性、随机、对照临床研究

Scientific title：

A single-center, prospective, randomized, controlled clinical study of tongue squamous cell carcinoma radical surgery and simultaneous free flap repair in the submental-mandibular dehiscence approach

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

芮涛 

研究负责人：

王友元 

Applicant：

Rui Tao 

Study leader：

Wang You Yuan 

申请注册联系人电话：

Applicant telephone：

18819486460

研究负责人电话：

Study leader's telephone：

13631333312

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

ruit@mail2.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

wangyy78@mail.sysu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

广东省广州市越秀区沿江西路107号

研究负责人通讯地址：

广东省广州市越秀区沿江西路107号

Applicant address：

107 Yanjiang W Rd,Yuexiu District, Guangzhou, Guangdong Province, China

Study leader's address：

107 Yanjiang W Rd,Yuexiu District, Guangzhou, Guangdong Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中山大学孙逸仙纪念医院口腔颌面外科

Applicant's institution：

Department of Oral and Maxillofacial Surgery，Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学孙逸仙纪念医院口腔颌面外科

Affiliation of the Leader：

Department of Oral and Maxillofacial Surgery，Sun Yat-sen Memorial Hospital of Sun Yat-sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2021-KY-117

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

中山大学孙逸仙纪念医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

2021-12-24 00:00:00

伦理委员会联系人：

林双秀

Contact Name of the ethic committee：

Lin Shuang Xiu

伦理委员会联系地址：

广东省广州市越秀区沿江西路107号

Contact Address of the ethic committee：

107 Yanjiang W Rd,Yuexiu District, Guangzhou, Guangdong Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中山大学孙逸仙纪念医院

Primary sponsor：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省广州市越秀区沿江西路107号

Primary sponsor's address：

107 Yanjiang W Rd, Yuexiu District, Guangzhou, Guangdong Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

中山大学孙逸仙纪念医院

具体地址：

越秀区沿江西路107号

Institution
hospital：

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Address：

107 Yanjiang Road West, Yuexiu District

经费或物资来源：

无经费

Source(s) of funding：

None

Target disease：

tongue squamous cell carcinoma

Target disease code：

C02.901

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

为解决舌鳞癌规范治疗同时兼顾颌面部外形这一临床问题，本申请项目通过多中心、前瞻性、随机、对照临床研究，观察颏下-颌下颌骨裂开进路组与对照组（正中裂开下唇及颌骨进路组），舌鳞癌根治同期游离皮瓣修复术后，两组患者3年总生存率，其次观察3年无瘤生存率，并通过华盛顿生活质量（UW-QOL）量表了解患者颌面部外形及由此导致的生活质量情况。  

Objectives of Study：

In order to solve the clinical problem of standardized treatment of tongue squamous cell carcinoma while taking into account the appearance of the maxillofacial region, this application project conducted a single-center, prospective, randomized, controlled clinical study to observe the submental-maxillomandibular dehiscence approach group and the control group ( Median dehiscence lower lip and jaw approach group), after radical tongue squamous cell carcinoma and free flap repair, the 3-year overall survival rate of the two groups of patients, followed by the 3-year disease-free survival rate, and the Washington quality of life (UW -QOL) scale to understand the patient's maxillofacial shape and the resulting quality of life.

药物成份或治疗方案详述：

治疗手段: 1）试验组（颏下-颌下颌骨裂开进路）手术方案： a. 患侧颏下-颌下切口切开皮肤及皮下组织（图一A），行颈淋巴清扫术。 b．对半舌切除者，向上翻开颏下-颌下切口，显露下颌骨颏部，将下颌骨裂开，离断舌外肌群并切开口底黏膜，将下颌骨近中断端向下后牵拉，远中断端向上牵拉，显露颌下空间，可直视舌鳞癌病灶，将舌从颌下空间牵拉出，即可在直视下行半舌切除术。对全舌或次全舌切除者，向上翻开颏下-颌下切口，显露下颌骨颏部，将下颌骨裂开，离断双侧二腹肌中间腱以及舌外肌群，切开口底黏膜，将下颌骨近、远中断端向两侧牵拉，显露颏下颌下空间，可直视舌鳞癌病灶，将舌从此空间牵拉出，即可在直视下行全舌或次全舌切除术。 c．皮瓣就位于舌缺损处，直视下对位缝合，再将舌重新推入口腔，将皮瓣动静脉分别与颈部受区血管吻合，钛板钛钉恢复下颌骨连续性及咬合关系，分层对位缝合颏下、颌下切口。 对照组（正中裂开下唇及颌骨进路）手术方案： a. 患侧颌下切口切开皮肤及皮下组织，行颈淋巴清扫术 b．对半舌切除者，正中切开下唇及颏部，与颈淋巴清扫切口相延续，显露下颌骨颏部，将下颌骨裂开，将下颌骨近、远中断端及唇颏部软组织向两侧牵拉，即可直视舌鳞癌病灶，离断舌外肌群并切开口底黏膜，将舌向口外牵拉，即可在直视下行半舌切除术。对全舌或次全舌切除者，同上显露舌病灶后，离断双侧二腹肌中间腱以及舌外肌群，切开口底黏膜，将将舌向口外牵拉，即可在直视下行全舌或次全舌切除术。 c．皮瓣就位于舌缺损处，直视下对位缝合，将皮瓣动静脉分别与颈部受区血管吻合，钛板钛钉恢复下颌骨连续性及咬合关系，分层对位缝合下唇、颏部及颌下切口。 

Description for medicine or protocol of treatment in detail：

1) The surgical plan of the experimental group (mental-mandibular dehiscence approach): a. The submental-submandibular incision on the affected side was used to incise the skin and subcutaneous tissue (Figure 1A), and a neck dissection was performed. b. For hemilingual excision, open the submental-submandibular incision upward to expose the chin of the mandible, split the mandible, cut off the extraglossus muscle group and cut the oral floor mucosa, and place the proximal end of the mandible downward and backward. The distal end is pulled upward to expose the submandibular space, and the tongue squamous cell carcinoma lesions can be viewed directly. For total or subtotal tongue resection, open the submental-submandibular incision upward to expose the chin of the mandible, split the mandible, cut off the middle tendon of the bilateral digastric muscles and the extraglossal muscle group, and make an incision. The bottom mucosa, the proximal and distal ends of the mandible are pulled to both sides to expose the submandibular space of the chin, and the tongue squamous cell carcinoma lesions can be viewed directly. Tongueectomy. c. The skin flap is located at the tongue defect, and the sutures are aligned under direct vision. The tongue is then pushed back into the oral cavity, and the arteries and veins of the skin flap are anastomosed with the vessels of the neck recipient area. The titanium plate and titanium screws restore the continuity and occlusal relationship of the mandible. Submental and submandibular incisions were sutured in layers. Control group (median dehiscence lower lip and jaw approach) surgical plan: a. Submandibular incision on the ipsilateral side to cut the skin and subcutaneous tissue, and perform neck dissection b. For the half-glossectomy, the lower lip and chin are incised in the middle, which is continued with the neck lymphatic dissection incision to expose the chin of the mandible. By pulling laterally, the squamous cell carcinoma of the tongue can be viewed directly, the extraglossal muscle group is cut off, the mucous membrane at the floor of the mouth is incised, and the tongue is pulled outside the mouth, and then hemiglossectomy can be performed under direct vision. For complete or sub-total tongue resection, after exposing the tongue lesions as above, the medial digastric tendon and the extraglossal muscle group on both sides are severed, the mucosa of the floor of the mouth is incised, and the tongue is pulled out of the mouth, and then the patient can be seen under direct vision. Perform a total or subtotal glossectomy. c. The flap was located at the tongue defect, and the flap was sutured in the opposite position under direct vision. The arterial and vein of the flap were anastomosed with the vessels of the neck recipient area. The titanium plate and titanium screws were used to restore the continuity and occlusal relationship of the mandible. Chin and submandibular incisions. 

纳入标准：

1）患者签署知情同意书当天的年龄为18周岁或以上；
2）病理诊断为舌鳞状细胞癌；
3）舌癌原发灶大小T2-T3，术前临床检查及影像学检查颈淋巴阴性（cN0），远处转移M0；
4）下唇、颏部无陈旧瘢痕及其他病变；
5）生命体征稳定，经常规检查表明可耐受手术者；
6）患者精神状态良好、能遵循医嘱，定期复诊者；
7）理解并愿意参加本项临床试验并提供签署的知情同意书。

Inclusion criteria

1) The age of the patient on the day of signing the informed consent is 18 years old or above;
2) The pathological diagnosis is tongue squamous cell carcinoma;
3) The primary tumor size of tongue cancer is T2-T3, the preoperative clinical examination and imaging examination are negative for cervical lymph node (cN0), and the distant metastasis is M0;
4) There are no old scars and other lesions on the lower lip and chin;
5) The vital signs are stable, and the routine examination shows that the operation can be tolerated;
6) The patient is in good mental state, can follow the doctor's orders, and have regular follow-up visits;
7) Understand and be willing to participate in this clinical trial and provide signed informed consent.

排除标准：

1）已存在的疾病会影响到切口愈合（如自身免疫病）；
2）瘢痕体质；
3）难以控制的高血糖（如HbA1c >12.0%）；
4) 经放疗科医生会诊需术后辅助放疗/放化疗的患者；
5）有严重未控制的疾病或全身急性感染者及合并其他严重心、肺、脑病等严重脏器疾病者；
6）合并有精神类疾病的患者；
7）研究人员认为不宜纳入者；
8）患者在过去任何时间参加这项研究。

Exclusion criteria：

1) Pre-existing disease will affect wound healing (such as autoimmune disease);
2) Scar constitution;
3) Uncontrolled hyperglycemia (such as HbA1c >12.0%);
4) Patients who need postoperative adjuvant radiotherapy/chemotherapy after consultation with radiotherapy physicians;
5) Those with severe uncontrolled disease or acute systemic infection, and those with other serious heart, lung, encephalopathy and other serious organ diseases;
6) Patients with psychiatric diseases;
7) Those who are considered inappropriate by the researchers to be included;
8) The patient participated in this study at any time in the past.

研究实施时间：

Study execute time：

从 From 2022-05-01 00:00:00至 To 2025-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2022-05-01 00:00:00 至 To 2025-04-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

92

Group：

Experimental group

Sample size：

干预措施：

颏下-颌下骨裂开入路

干预措施代码：

Intervention：

submental-submandibular dehiscence approach

Intervention code：

组别：

对照组

样本量：

92

Group：

Control group

Sample size：

干预措施：

正中裂开下唇入路

干预措施代码：

Intervention：

Median split lower lip approach

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China 

Province：

Guangdong 

City：

Guangzhou 

单位(医院)：

中山大学孙逸仙纪念医院 

单位级别：

三级甲等 

Institution
hospital：

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

华盛顿生活质量量表调查问卷

指标类型：

主要指标

Outcome：

University of Washington Quality of Life Questionnaire

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

3年总生存率

指标类型：

次要指标

Outcome：

3-year overall survival rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

3年无瘤生存率

指标类型：

次要指标

Outcome：

3-year disease-free survival rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

温哥华瘢痕量表

指标类型：

次要指标

Outcome：

Vancouver Scar Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机数法，由SAS软件生成随机号，实时短信反馈研究者分组组别

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random number method, random numbers are generated by SAS software, and real-time SMS feedback to researchers into groups

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

通过网盘文件，https://pan.baidu.com，于研究结束后可共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Through the network disk file, https://pan.baidu.com, can be shared after the study is completed

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1.使用CRF表收集数据 2.试验组患者与对照组患者的所有临床数据将会保存于项目负责人处并备份于科室内计算机。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1. Use the CRF form to collect data 2. All clinical data of the patients in the experimental group and the patients in the control group will be saved in the project leader and backed up on the computer in the department.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-01-14 22:32:26