ChiCTR2600118271 版本V1.0 版本创建时间2026/02/03 18:12:05 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：

 ChiCTR2600118271 

最近更新日期：

Date of Last Refreshed on：

 2026-02-03 18:12:00 

注册时间：

Date of Registration：

 2026-02-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

新型淋巴示踪剂盐酸米托蒽醌在改善分化型甲状腺癌根治术后疗效及患者预后中的应用研究

Public title：

The Application of New Lymphatic Tracers Mitozantrone Hydrochloride in Improving the Efficacy and Prognosis of Patients After Radical Surgery for Differentiated Thyroid Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

新型淋巴示踪剂盐酸米托蒽醌在改善分化型甲状腺癌根治术后疗效及患者预后中的应用研究

Scientific title：

The Application of New Lymphatic Tracers Mitozantrone Hydrochloride in Improving the Efficacy and Prognosis of Patients After Radical Surgery for Differentiated Thyroid Cancer

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：

程宇 

研究负责人：

程宇 

Applicant：

Yu Cheng 

Study leader：

Yu Cheng 

申请注册联系人电话：

Applicant telephone：

 +86 176 1158 8968

研究负责人电话：

Study leader's
telephone：

+86 176 1158 8968

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：

 blue8968@foxmail.com

研究负责人电子邮件：

Study leader's E-mail：

 blue8968@foxmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Tianjin First Central Hospital

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：

天津市西青区西营门街道保山西道2号

研究负责人通讯地址：

天津市西青区西营门街道保山西道2号

Applicant address：

No. 2 Baoshan West Road, Xiyingmen Street, Xiqing District, Tianjin

Study leader's address：

No. 2 Baoshan West Road, Xiyingmen Street, Xiqing District, Tianjin

申请注册联系人邮政编码：

Applicant postcode：

 300192

研究负责人邮政编码：

Study leader's postcode：

 300192

申请人所在单位：

天津市第一中心医院

Applicant's institution：

Tianjin First Central Hospital

研究负责人所在单位：

天津市第一中心医院

Affiliation of the Leader：

Tianjin First Central Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022DZX02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

天津市第一中心医院科技伦理委员会

Name of the ethic committee：

Science and Technology Ethics Committee of TFCH

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-01 00:00:00

伦理委员会联系人：

巩欣媛

Contact Name of the ethic committee：

Xinyuan Gong

伦理委员会联系地址：

天津市西青区西营门街保山西道2号 天津市第一中心医院水西院区（药械伦理审查委员会办公室，F区健康广场118室）

Contact Address of the ethic committee：

No. 2 Baoshan West Road, Xiyingmen Street, Xiqing District, Tianjin, Tianjin First Central Hospital, Shuixi Campus (Office of the Ethics Committee for Drugs and Medical Devices, Room 118, F Zone Health Plaza).

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 22 2362 8843

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：

天津市第一中心医院

Primary sponsor：

Tianjin First Central Hospital

研究实施负责（组长）单位地址：

天津市西青区西营门街道保山西道2号

Primary sponsor's address：

No. 2 Baoshan West Road, Xiyingmen Street, Xiqing District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津市

市(区县)：

天津市

Country：

China

Province：

Tianjin

City：

Tianjin

单位(医院)：

天津市第一中心医院

具体地址：

天津市西青区西营门街道保山西道2号

Institution
hospital：

Tianjin First Central Hospital

Address：

No. 2 Baoshan West Road, Xiyingmen Street, Xiqing District, Tianjin

经费或物资来源：

北京健康促进会甲状腺中青年医生研究项目（项目：BJHPA-2022-JZHXZHQNYJ-LCH-12）

Source(s) of funding：

Beijing Health Promotion Association Young and Middle-aged Thyroid Doctors Research Program (Project No. BJHPA-2022-JZHXZHQNYJ-LCH-12)

研究疾病：

甲状腺肿瘤  

Target disease：

Thyroid tumor

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

前瞻性临床研究观察示踪用盐酸米托蒽醌在甲状腺癌根治术中区域淋巴结清扫中的临床疗效，通过分析盐酸米托蒽醌与纳米碳示踪法在淋巴结染色和淋巴结清扫数目差异性，评估盐酸米托蒽醌在实现甲状腺癌根治术治疗中的临床应用价值，阐明盐酸米托蒽醌应用在区域淋巴结清扫过程中对甲状旁腺及喉返神经保护的临床意义，进一步探究盐酸米托蒽醌在分化型甲状腺癌根治术中行彻底淋巴结清扫的临床优势，同时制定并完善诊疗方案，为临床推广提供循证依据。  

Objectives of Study：

This prospective clinical study investigates the clinical efficacy of mitoxantrone hydrochloride used as a tracer in regional lymph node dissection during radical surgery for thyroid cancer. By analyzing the differences between mitoxantrone hydrochloride and the carbon nanoparticle tracing method in terms of lymph node staining and the number of dissected lymph nodes, the clinical application value of mitoxantrone hydrochloride in achieving radical treatment of thyroid cancer is evaluated. The study further elucidates the clinical significance of mitoxantrone hydrochloride in protecting the parathyroid glands and the recurrent laryngeal nerve during regional lymph node dissection. In addition, it explores the clinical advantages of mitoxantrone hydrochloride in facilitating thorough lymph node dissection in radical surgery for differentiated thyroid carcinoma, while formulating and optimizing diagnostic and therapeutic protocols to provide evidence-based support for clinical promotion.

药物成份或治疗方案详述：

本研究为单中心前瞻性随机对照临床研究。选取2022年7月至2023年12月间在本单位确诊为分化型甲状腺癌并拟行外科手术治疗的患者为研究对象，遵循入选标准和排除标准筛选患者，并按照随机数表法将纳入患者分为盐酸米托蒽醌示踪组（实验组）、纳米碳示踪组（对照组）和空白组，每组纳入30例。其中实验组在甲状腺癌根治术中采用盐酸米托蒽醌对淋巴结进行染色示踪，对照组在手术过程中采用纳米碳进行染色示踪，空白组则采用常规外科方式进行操作，手术过程中不应用任何淋巴示踪剂进行辅助。临床招募过程中，确保三组患者性别、年龄、BMI、肿瘤大小等基线资料无统计学差异。详细记录所有患者术前一般临床资料。所有患者及其家属均需在术前详细了解入组情况，术前签署知情同意书，并经医院伦理委员会审批通过。 所有患者均行全甲状腺切除联合双侧颈部中央区淋巴结清扫，其中部分侧颈淋巴结转移者行侧颈淋巴结清扫术。患者采取全身麻醉方案，取仰卧位，头部后仰、肩部垫高。常规消毒后取胸骨上窝2cm处顺皮纹做弧形切口，逐层切开并沿中线切开颈前肌群拉向两侧，充分暴露甲状腺。待双侧腺叶显露后，实验组术中常规显露甲状腺腹侧被膜，一般不超过腺体中、外1/3处，避免因过多游离腺体破坏甲状腺周围淋巴管网，影响示踪剂的染色效果。实验组在腺体上注射示踪用盐酸米托蒽醌注射液，对照组注射纳米碳，空白组注射等量生理盐水。注射方法：1ml空针抽取0.2ml不同试剂，于甲状腺上极、下极各选取4个点，尽可能在瘤体四周选择注射点，以便示踪剂能快速进入淋巴系统进行染色；在注射推注过程前应进行回吸操作，避免将染色试剂注射到血管中；注射完成后用纱布稍作按压和轻揉等操作，防止注射试剂外漏并有利于均匀分布和吸收。随后见淋巴结和淋巴管蓝染或黑染后，继续手术切除病变腺叶。同时根据负染色情况应用双极电凝镊小心分离甲状旁腺及其滋养血管。同样在整个手术过程中清除双侧喉返神经周围脂肪及淋巴组织，上至甲状软骨水平，下至无名动脉上缘水平，外侧至颈动脉鞘内侧缘，内侧至对侧气管旁；同时清除气管前、气管旁及喉前淋巴结。创面彻底止血，放置1枚引流管，逐层关闭手术切口。另外，术中暴露喉返神经和区域淋巴结清扫的手术操作均由同一名副高级手术医师完成，尽可能避免研究偏倚。 

Description for medicine or protocol of treatment in detail：

This study was a single-center, prospective, randomized controlled clinical trial. Patients diagnosed with differentiated thyroid carcinoma at our institution between July 2022 and December 2023 and scheduled for surgical treatment were enrolled in this study. Eligible patients were screened in accordance with predefined inclusion and exclusion criteria and were randomly assigned, using a random number table, to the mitoxantrone hydrochloride tracing group (experimental group), the carbon nanoparticle tracing group (control group), or the blank group, with 30 patients in each group. In the experimental group, mitoxantrone hydrochloride was used for lymph node staining and tracing during radical thyroid cancer surgery. In the control group, carbon nanoparticles were used as the lymphatic tracer during surgery, whereas the blank group underwent conventional surgical procedures without the use of any lymphatic tracing agent. During patient recruitment, baseline characteristics, including sex, age, body mass index (BMI), tumor size, and other clinical parameters, were ensured to be comparable among the three groups, with no statistically significant differences. Detailed preoperative clinical data were recorded for all patients. All patients and their family members were fully informed about the study prior to surgery, provided written informed consent, and the study protocol was approved by the hospital ethics committee. All patients underwent total thyroidectomy combined with bilateral central neck lymph node dissection. Patients with lateral cervical lymph node metastasis additionally underwent lateral neck lymph node dissection. General anesthesia was administered, and patients were placed in the supine position with the head extended and shoulders elevated. After routine disinfection, a curved incision was made along the skin crease approximately 2 cm above the suprasternal notch. The incision was deepened layer by layer, and the anterior cervical muscles were divided along the midline and retracted laterally to fully expose the thyroid gland. After bilateral thyroid lobes were adequately exposed, the ventral capsule of the thyroid gland was routinely exposed in the experimental group, generally not exceeding the middle to lateral one-third of the gland, to avoid excessive mobilization that could damage the perithyroidal lymphatic network and compromise tracer staining. In the experimental group, mitoxantrone hydrochloride injection was administered into the thyroid gland as a lymphatic tracer; in the control group, carbon nanoparticles were injected; and in the blank group, an equivalent volume of normal saline was injected. Injection technique: a 1 mL syringe was used to draw 0.2 mL of the designated agent, and four injection points were selected at both the superior and inferior poles of the thyroid gland, preferentially around the tumor, to facilitate rapid entry of the tracer into the lymphatic system. Aspiration was performed prior to injection to avoid intravascular administration. After injection, gentle compression and massage with gauze were applied to prevent leakage and promote uniform distribution and absorption of the tracer. Once blue or black staining of lymph nodes and lymphatic vessels was observed, resection of the affected thyroid lobe was continued. Based on the negative staining pattern, the parathyroid glands and their nourishing vessels were carefully dissected using bipolar electrocautery forceps. Throughout the procedure, adipose and lymphatic tissues surrounding the bilateral recurrent laryngeal nerves were meticulously removed, with the superior boundary at the level of the thyroid cartilage, the inferior boundary at the upper border of the innominate artery, the lateral boundary at the medial edge of the carotid sheath, and the medial boundary extending to the contralateral paratracheal region. In addition, pretracheal, paratracheal, and prelaryngeal lymph nodes were dissected. After thorough hemostasis, a single drainage tube was placed, and the incision was closed in layers. To minimize potential bias, all procedures involving exposure of the recurrent laryngeal nerve and regional lymph node dissection were performed by the same senior attending surgeon. 

纳入标准：

1.患者年龄为18-69岁；2.患者经术前超声弹性成像、细针穿刺病理评估且均经术后组织病理学证实为双侧乳头状癌或滤泡状癌；3.均在术前或随访过程中获取完整的临床病理学资料，包括术前血钙水平、甲状旁腺素水平、病理组织学分级、肿瘤大小、肿瘤病灶数目等；4.患者术前未接受射频或微波消融、无水酒精注射、化疗或靶向药物等抗肿瘤方案治疗；5.所有患者均为首次手术；6.术前血清钙、甲状旁腺激素水平正常；7.患者神志清晰，生命体征平稳，能自主配合进行量表评估者；8.患者依从性良好，无精神疾病及意识障碍，能坚持定期复查。

Inclusion criteria

1.The patients were aged between 18 and 69 years.2.All patients were preoperatively evaluated using ultrasound elastography and fine-needle aspiration cytology, and subsequently confirmed by postoperative histopathological examination to have bilateral papillary or follicular thyroid carcinoma.3.Comprehensive clinicopathological data were obtained either preoperatively or during follow-up, including preoperative serum calcium levels, parathyroid hormone (PTH) levels, histological tumor grading, tumor size, and the number of tumor foci.4.None of the patients received anti-tumor therapies such as radiofrequency ablation, microwave ablation, percutaneous ethanol injection, chemotherapy, or targeted therapy prior to surgery.5.All patients underwent their first surgical procedure.6.Preoperative serum calcium and parathyroid hormone levels were within normal limits.7.Patients were conscious, hemodynamically stable, and able to cooperate independently in completing scale-based assessments.8.Patients demonstrated good compliance, had no psychiatric disorders or consciousness disturbances, and were able to adhere to regular follow-up examinations.

排除标准：

1.存在各种进展期代谢性疾病者；2.存在有症状的脑血管或外周血管病变；3.合并远处转移者；4.预计生存期?６个月；5.存在盐酸米托蒽醌或纳米碳过敏禁忌者；6.合并严重心、肝、肾功能障碍、凝血系统功能异常以及严重脑功能障碍者；7.有甲状腺癌以外的其他恶性肿瘤病史者。

Exclusion criteria：

1.Patients with various advanced-stage metabolic disorders.2.Patients with symptomatic cerebrovascular or peripheral vascular disease.3.Patients with concomitant distant metastases.4.Patients with an expected survival time of less than 6 months.5.Patients with known hypersensitivity or contraindications to mitoxantrone hydrochloride or nano-carbon.6.Patients with severe cardiac, hepatic, or renal dysfunction, coagulation disorders, or significant neurological impairment.7.Patients with a history of malignancies other than thyroid carcinoma.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-16 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 30

Group：

The experimental group

Sample size：

干预措施：

实验组在甲状腺癌根治术中采用示踪用盐酸米托蒽醌对淋巴结进行染色示踪

干预措施代码：

Intervention：

In the experimental group, mitoxantrone hydrochloride was used as a tracer for lymph node staining during radical thyroid cancer surgery.

Intervention code：

组别：

对照组

样本量：

 30

Group：

The control group

Sample size：

干预措施：

对照组在甲状腺癌根治术中采用纳米碳对淋巴结进行染色示踪

干预措施代码：

Intervention：

In the control group, carbon nanoparticles were used for lymph node staining and tracing during radical thyroid cancer surgery.

Intervention code：

组别：

空白组

样本量：

 30

Group：

The blank group

Sample size：

干预措施：

空白组在甲状腺癌根治术中采用等量生理盐水注射方法进行处理

干预措施代码：

Intervention：

In the blank group, an equivalent volume of normal saline was injected during radical thyroid cancer surgery.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津 

市(区县)：

 天津 

Country：

China

Province：

Tianjin

City：

Tianjin

单位(医院)：

 天津市第一中心医院 

单位级别：

 三甲 

Institution
hospital：

Tianjin First Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

手术时间

指标类型：

附加指标

Outcome：

Operation time

Type：

Additional indicator

测量时间点：

手术时间以开皮时刻开始计时，直至全部甲状腺完整切除停止计时

测量方法：

应用计时器，以分钟（min）为单位统计结果

Measure time point of outcome：

The surgical time is measured from the moment the skin is incised until the complete removal of the thyroid gland is completed.

Measure method：

Use a timer to record the results in minutes (min).

指标中文名：

术中出血量

指标类型：

附加指标

Outcome：

Intraoperative blood loss

Type：

Additional indicator

测量时间点：

手术前后纱布重量差计算得出吸收的血液量

测量方法：

采用微量称称量，每增重1克约等于1 ml血液

Measure time point of outcome：

The difference in the weight of the gauze before and after the surgery was used to calculate the amount of blood absorbed.

Measure method：

Using micro-weighing, each increase of 1 gram in weight is approximately equivalent to 1 milliliter of blood.

指标中文名：

住院时间

指标类型：

附加指标

Outcome：

Hospitalization period

Type：

Additional indicator

测量时间点：

住院时间自入院首日开始直至出院当日计算

测量方法：

以天（d）为单位统计结果

Measure time point of outcome：

From the first day of admission until the day of discharge

Measure method：

The results are presented in units of days (d).

指标中文名：

淋巴结清扫效果

指标类型：

主要指标

Outcome：

The effect of lymph node dissection

Type：

Primary indicator

测量时间点：

测量方法：

通过术后病理学诊断方法，分析三组患者手术过程中淋巴结清扫数目以及所清扫淋巴结中发生阳性转移的数目

Measure time point of outcome：

Measure method：

Through postoperative pathological diagnosis methods, the number of lymph nodes removed during the surgery and the number of positive metastases in the removed lymph nodes were analyzed for the three groups of patients.

指标中文名：

示踪效果评价

指标类型：

主要指标

Outcome：

Traceability effect evaluation

Type：

Primary indicator

测量时间点：

测量方法：

采用淋巴结染色程度评分和示踪成功率对示踪效果进行评价。其中淋巴结染色程度评分标准：0分：淋巴结颜色无改变；1分：可见淋巴结或边缘窦轻度或部分蓝染或黑染；2分：可见整个淋巴结深度蓝染或黑染。示踪成功率=（染色的淋巴结总数/清除的淋巴结总数）×100%。

Measure time point of outcome：

Measure method：

The tracing effect was evaluated by using the scoring of lymph node staining degree and the success rate of tracing. The scoring standard for lymph node staining degree: 0 points: no change in the color of the lymph node; 1 point: slight or partial blue or black staining of the lymph node or its margin; 2 points: deep blue or black staining of the entire lymph node. The success rate of tracing = (total number of stained lymph nodes / total number of removed lymph nodes) × 100%.

指标中文名：

甲状旁腺识别及误切损伤情况

指标类型：

主要指标

Outcome：

Parathyroid gland recognition and the situation of accidental resection or injury

Type：

Primary indicator

测量时间点：

测量方法：

Suspected parathyroid tissue was identified based on anatomical location, staining characteristics, morphology, and color. A 1-mL sterile syringe containing 0.1 mL of normal saline was used to puncture the capsule of the suspected parathyroid gland, followed by repeated aspiration of the tissue. A small amount of the aspirated fluid was then dropped onto a parathyroid hormone (PTH) test cassette and incubated for 3 minutes. PTH levels were determined using an immunochromatographic assay to confi

Measure time point of outcome：

Measure method：

指标中文名：

术野清晰度评价

指标类型：

主要指标

Outcome：

Evaluation of surgical field clarity

Type：

Primary indicator

测量时间点：

测量方法：

由同一术者参照Fromme评分术野质量评分表对淋巴染色区域清晰度进行评分，评价标准中共设置为1-5分，其中5分：术野除淋巴系统外，无特殊染色，甲状旁腺辨识清晰；4分：除淋巴系统外，术野其他区域存在轻微特殊染色，不妨碍术野，可通过负显影辨识甲状旁腺；3分：术野区域内除淋巴结外，仍存在小面积特殊染色，影响甲状旁腺辨识；2分：术野区域内除淋巴结外，存在大面积特殊染色，甲状旁腺辨识困难；1分：术野区域严重大面积染色，无法辨识甲状旁腺及周围毗邻神经，妨碍手术操作。分析三组患者术中术野清晰度评分，评价术中染色质量情况。

Measure time point of outcome：

Measure method：

The clarity of the lymphatic staining field was assessed by the same surgeon using the Fromme Surgical Field Quality Score. The evaluation scale ranged from 1 to 5 points, with the following criteria: 5 points: No abnormal staining was observed in the surgical field outside the lymphatic system, and the parathyroid glands were clearly identifiable; 4 points: Mild abnormal staining was present in areas other than the lymphatic system but did not interfere with the surgical field, and the parathyr

指标中文名：

血钙水平

指标类型：

主要指标

Outcome：

Calcium level

Type：

Primary indicator

测量时间点：

术后1天、3天、7天、1月

测量方法：

晨起静脉采血5mL，采用全自动生化分析仪测定血清钙水平，低于2.0mmol/L以下定义为低血钙

Measure time point of outcome：

One day, three days, seven days and one month after the operation

Measure method：

Collect 5 mL of venous blood in the morning. Use an automatic biochemical analyzer to measure the serum calcium level. A value below 2.0 mmol/L is defined as hypocalcemia.

指标中文名：

甲状旁腺激素水平

指标类型：

主要指标

Outcome：

PTH level

Type：

Primary indicator

测量时间点：

术后1天、3天、7天、1月

测量方法：

晨起静脉采血5mL，采用酶联免疫吸附法（ELISA）测定PTH水平，PTH?15pg/mL定义为甲状旁腺功能减退

Measure time point of outcome：

One day, three days, seven days and one month after the operation

Measure method：

Collect 5 mL of venous blood in the morning. Use the enzyme-linked immunosorbent assay (ELISA) to determine the PTH level. PTH less than 15 pg/mL is defined as hypoparathyroidism.

指标中文名：

围术期相关并发症

指标类型：

主要指标

Outcome：

Perioperative related complications

Type：

Primary indicator

测量时间点：

围手术期

测量方法：

观察并记录三组患者围手术期治疗中相关性并发症情况，有无声音嘶哑、肢体麻木、手足抽搐、惊厥、甲状旁腺功能减退等并发症情况。

Measure time point of outcome：

Perioperative period

Measure method：

Observe and record the occurrence of relevant complications during the perioperative treatment of the three groups of patients, including cases of hoarseness of voice, numbness of limbs, convulsions of hands and feet, seizures, and hypoparathyroidism.

指标中文名：

淋巴结转移率

指标类型：

主要指标

Outcome：

Lymph node metastasis rate

Type：

Primary indicator

测量时间点：

术后随访12个月

测量方法：

自接受手术治疗之日起计算，以月为单位，采用门诊复诊及电话随访方式对患者进行规律随访，随访时限为12个月。记录三组患者随访期间淋巴结转移率。

Measure time point of outcome：

Postoperative follow-up for 12 months

Measure method：

Follow-up was initiated from the date of surgical treatment and conducted on a monthly basis through outpatient visits and telephone interviews, with a follow-up duration of 12 months. The lymph node metastasis rate during the follow-up period was recorded for patients in all three groups.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

淋巴结组织

组织：

颈部区域淋巴结

Sample Name：

Lymph node tissue

Tissue：

Lymph nodes in the neck region

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 69 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）：

随机方法（随机序列的产生）：本研究为前瞻性随机对照研究，受试者在满足纳入/排除标准并签署知情同意后，按照1:1:1比例分配至盐酸米托蒽醌示踪组（实验组）、纳米碳示踪组（对照组）和无淋巴示踪剂组（空白组），计划每组30例。 随机序列由独立的统计学人员/临床研究秘书（不参与受试者招募、手术实施及结局评估）负责生成：采用计算机随机数方法（以随机数表法为原则实现），使用统计软件（如 SPSS 的随机数生成功能或同等可靠软件）生成受试者入组顺序对应的随机分配序列，并据此形成三组分配表，确保随机分配的不可预测性与可追溯性。

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

Randomization method (generation of the random sequence): This study was designed as a prospective randomized controlled trial. After meeting the inclusion and exclusion criteria and providing written informed consent, eligible participants were allocated in a 1:1:1 ratio to the mitoxantrone hydrochloride tracing group (experimental group), the carbon nanoparticle tracing group (control group), or the no–lymphatic tracer group (blank group), with a planned sample size of 30 patients per group. The random allocation sequence was generated by an independent statistician or clinical research coordinator who was not involved in participant recruitment, surgical procedures, or outcome assessment. A computer-generated random number method was used, based on the principles of a random number table, and implemented using statistical software (e.g., the random number generation function in SPSS or equivalent validated software). The resulting allocation sequence was used to create the three-group assignment list, thereby ensuring the unpredictability and traceability of the randomization process.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究为非盲法随机对照临床试验。由于不同淋巴示踪方式（盐酸米托蒽醌、纳米碳或未使用示踪剂）在手术过程中存在客观差异，手术操作者无法实施盲法。 为尽量减少观察者偏倚，本研究在数据收集与统计分析阶段采取部分盲法措施：研究结局评估人员及统计分析人员在数据分析前不知晓具体分组信息，各研究组以编码形式表示，在完成统计分析后方进行揭盲。 通过随机分组与结局评估及统计分析阶段的盲法设计，最大程度降低研究偏倚，确保研究结果的科学性与可靠性。

Blinding：

This study was conducted as an open-label randomized controlled clinical trial. Due to the inherent differences among the lymphatic tracing methods used during surgery (mitoxantrone hydrochloride, carbon nanoparticles, or no tracer), blinding of the operating surgeons was not feasible. To minimize observer bias, partial blinding was implemented during the data collection and statistical analysis phases. Outcome assessors and statistical analysts were blinded to group allocation prior to data analysis, with study groups identified using coded labels. Unblinding was performed only after completion of the statistical analyses. Through the combination of randomized allocation and blinding at the outcome assessment and statistical analysis stages, potential study bias was minimized to the greatest extent possible, thereby ensuring the scientific rigor and reliability of the study findings.

是否共享原始数据：

IPD sharing

是Yes

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）：

公开共享数据日期：2026年1月22日，国家生物信息中心（项目编号：PRJCA056498）；https://ngdc.cncb.ac.cn/gsub/submit/bioproject/list

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

China National center for Bioinformation(Project ID: PRJCA040505); https://ngdc.cncb.ac.cn/gsub/submit/bioproject/list

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：

电子采集和管理系统

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

Electronic Data Capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-02-03 18:12:00