ChiCTR2500112678 版本V1.0 版本创建时间2025/11/18 11:17:38 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：

ChiCTR2500112678 

最近更新日期：

Date of Last Refreshed on：

2025-11-18 11:17:27 

注册时间：

Date of Registration：

2025-11-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

实时手术导航技术辅助腹腔镜半肝切除术的安全性和可行性评估：一项单中心单盲随机对照临床试验

Public title：

Safety and feasibility of laparoscopic hemihepatectomy assisted by real-time surgical navigation technology: a single-center, single-blind, randomized controlled clinical trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

实时手术导航技术辅助腹腔镜半肝切除术的安全性和可行性评估：一项单中心单盲随机对照临床试验

Scientific title：

Safety and feasibility of laparoscopic hemihepatectomy assisted by real-time surgical navigation technology: a single-center, single-blind, randomized controlled clinical trial

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：

刘利平 

研究负责人：

刘利平 

Applicant：

Liping Liu 

Study leader：

Liping Liu 

申请注册联系人电话：

Applicant telephone：

+86 137 5103 7156

研究负责人电话：

Study leader's telephone：

+86 137 5103 7156

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：

liuliping@mail.sustech.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

liuliping@mail.sustech.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：

深圳市罗湖区东门北路1017号

研究负责人通讯地址：

深圳市罗湖区东门北路1017号

Applicant address：

No. 1017, Dongmen North Road, Luohu District, Shenzhen

Study leader's address：

No. 1017, Dongmen North Road, Luohu District, Shenzhen

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：

深圳市人民医院

Applicant's institution：

Shenzhen People's Hospital

研究负责人所在单位：

深圳市人民医院

Affiliation of the Leader：

Shenzhen People's Hospital

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：

LL-KY-2025250-02

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：

深圳市人民医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee of Shenzhen People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-10 00:00:00

伦理委员会联系人：

骆老师

Contact Name of the ethic committee：

Mr. Luo

伦理委员会联系地址：

深圳市罗湖区东门北路1017号

Contact Address of the ethic committee：

No. 1017, Dongmen North Road, Luohu District, Shenzhen

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 2294 3881

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：

深圳市人民医院

Primary sponsor：

Shenzhen People's Hospital

研究实施负责（组长）单位地址：

深圳市罗湖区东门北路1017号

Primary sponsor's address：

No. 1017, Dongmen North Road, Luohu District, Shenzhen

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

深圳市人民医院

具体地址：

深圳市罗湖区东门北路1017号

Institution
hospital：

Shenzhen People's Hospital

Address：

No. 1017, Dongmen North Road, Luohu District, Shenzhen

经费或物资来源：

深圳市科技创新委员会重点项目

Source(s) of funding：

Key project of Shenzhen Science and Technology Innovation Committee

Target disease：

Hepatocellular carcinoma

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：

主要目的：评价实时手术导航系统辅助下的腹腔镜半肝切除术在减少术中单位肝切面积出血和提高手术安全性方面的应用价值。 次要目的：探索导航系统对单位肝切面积手术时长、手术并发症和肿瘤切除质量（R0切除率、术后肝功能恢复、住院时间等恢复指标的影响；分析不同解剖复杂度患者中导航系统的临床应用价值。  

Objectives of Study：

Main objective: To evaluate the application value of laparoscopic hemihepatectomy assisted by real-time surgical navigation system in reducing intraoperative blood loss per unit hepatectomy area and improving surgical safety. Secondary objectives: To explore the effects of the navigation system on the operation time per unit liver resection area, surgical complications, and tumor resection quality (R0 resection rate, postoperative liver function recovery, length of hospital stay, and other recovery indicators), and to analyze the clinical application value of the navigation system in patients with different anatomical complexity.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 年龄在18–75岁，性别不限；2. 影像学及术前评估明确肝脏占位病变（可疑肝脏肿瘤），且拟行腹腔镜半肝切除术；3. 术前肝功能 Child-Pugh A 或 B 级，ICG R15 ≤ 15%；4. ECOG评分0-1分；5.术前经多学科团队和科室术前讨论评估具备腹腔镜手术适应证者；6.自愿参加研究并签署知情同意书者。

Inclusion criteria

1. Age of 18-75 years old, both sexes; 2. Imaging and preoperative evaluation confirmed liver occupying lesions (suspected liver tumor), and laparoscopic hemihepatectomy was planned; 3.Preoperative liver function Child-Pugh A or B, ICG R15 <= 15%; 4. ECOG score 0-1; 5. The indications for laparoscopic surgery were evaluated by the multidisciplinary team and the department before surgery; 6. Those who volunteered to participate in the study and signed the informed consent form.

排除标准：

1. 存在严重心肺功能障碍或其他重要脏器功能不全，无法耐受手术者；2.合并远处转移或腹膜广泛种植者；3. 既往上腹部重大手术史导致严重粘连影响腹腔镜操作者；4. 妊娠或哺乳期妇女；精神或认知功能障碍无法配合研究者；5. 术中因肿瘤侵犯范围或其他原因需要扩大手术切除范围，导致无法完成预定方案者。

Exclusion criteria：

1. Patients with severe cardiopulmonary dysfunction or other important organ dysfunction, unable to tolerate surgery; 2. Distant metastasis or extensive peritoneal dissemination; 3.Previous history of major upper abdominal surgery leading to severe adhesion affecting the laparoscopic operator; 4. Pregnant or lactating women; Inability to cooperate with the investigator due to mental or cognitive impairment; 5. The planned plan could not be completed because of tumor invasion or other reasons to expand the scope of surgical resection during operation.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2028-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-11-30 00:00:00 至 To 2027-10-01 00:00:00  

干预措施：

Interventions：

组别：

导航组

样本量：

28

Group：

Navigation group

Sample size：

干预措施：

使用手术辅助导航系统进行腹腔镜半肝切除术

干预措施代码：

Intervention：

A surgical navigation system was used to perform laparoscopic hemihepatectomy.

Intervention code：

组别：

非导航组

样本量：

28

Group：

Non-navigation group

Sample size：

干预措施：

不使用手术辅助导航系统进行腹腔镜半肝切除术，就传统的腹腔镜半肝切除术

干预措施代码：

Intervention：

Conventional laparoscopic hemihepatectomy was performed without the use of surgical navigation system.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 深圳 

Country：

China 

Province：

Guangdong 

City：

Shenzhen 

单位(医院)：

深圳市人民医院 

单位级别：

三甲 

Institution
hospital：

Shenzhen People's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术中单位肝切面积的出血量

指标类型：

主要指标

Outcome：

Intraoperative blood loss per unit liver resection area

Type：

Primary 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：

血液

组织：

Sample Name：

Blood

Tissue：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

1.所有符合纳入标准并签署知情同意的患者，将在术前按照1:1比例随机分配至实时手术导航系统辅助腹腔镜半肝切除组或常规腹腔镜半肝切除组；2. 随机化过程由独立的研究协调员通过计算机生成的随机数字表完成，并使用封闭不透明信封进行分配，确保分组的不可预测性；3. 患者一经分组，不得随意更改，除非出现不可抗力或严重医疗安全原因。

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

1.All patients who met the inclusion criteria and signed informed consent were randomly assigned in a 1:1 ratio to the real-time surgical navigation system assisted laparoscopic hemihepatectomy group or the conventional laparoscopic hemihepatectomy group before surgery. 2. Randomization was performed by an independent study coordinator with the use of computer-generated random-number tables and was performed with the use of closed opaque envelopes to ensure unpredictability of treatment assignments. 3. The grouping of patients shall not be changed at will, unless there is force majeure or serious medical safety reasons.

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：

1. 术者非盲法；2. 患者盲法（单盲）：患者在入组时仅被告知接受腹腔镜半肝切除，不告知是否使用导航系统；3. 术后评估盲法：术后随访、并发症评估、影像学复查及病理切缘判定均由不参与手术、未知分组信息的独立评估团队完成；4. 数据分析盲法：统计人员在数据分析前，使用匿名编码隐藏分组信息，仅在分析完成后才进行揭盲。

Blinding：

1. The surgeon was unblinded; 2.Patient blinding (single blind) : patients were only informed that they would undergo laparoscopic hemihepatectomy at enrollment, and were not informed whether to use the navigation system or not; 3. Blind method of postoperative evaluation: postoperative follow-up, complication evaluation, imaging review and pathological margin determination were completed by an independent evaluation team who did not participate in the operation and did not know the grouping information. 4. Blinding of data analysis: the statisticians used anonymous codes to hide group information before data analysis, and unblinding was performed only after the analysis was completed.

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）：

共享原始数据需本研究以论文的形式发表后（2028年10月31日后）通过与项目负责人联系沟通的方式共享

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

The raw data should be shared with the principal investigator after the publication of the study in the form of a paper (after October 31, 2028)

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：

本研究的数据管理按照严格的分步流程进行。首先，在术前基线、术中实时、术后住院期间每日及术后1、3、6、12个月随访阶段，由手术医生、护理人员及随访成员负责完成数据采集，所有原始信息记录在纸质标准化病例报告表（CRF）中，暂时保存在科室或病案室，随后由专人录入至Excel电子数据库。如发现采集错误或遗漏，将重新核实并补充。纸质CRF在录入并复核后存档，后续由数据管理员统一管理，不再改动。 其次，数据录入工作在采集后1–3个工作日内由专职数据录入的研究成员完成，录入介质为加密电子数据采集系统（Excel），系统具有用户权限管理和日志记录功能。录入错误或发现数据不符时，需通过质疑流程申请校正。录入后实行双人复核，复核通过后数据暂时锁定。 随后，数据质疑环节在数据录入完成后立即启动，并在随访期间持续进行，至少每月开展一次，由数据管理和统计人员负责。质疑过程在电子表格的质疑管理模块中完成，所有质疑与回复均有电子记录。若发现异常值、逻辑冲突或数据缺失，系统会自动通知相关采集人员，经确认无误后方可修改，未解决的问题则暂停锁定相关字段。 数据修改须在收到质疑后3个工作日内完成，由原始数据采集人员、数据录入员及数据管理员共同参与。所有修改在电子系统中自动记录修改日志，并须说明原因。任何修改必须经过审批，未经批准不得擅自更改，修改完成后需重新提交复核。 最后，数据将在预计2028年3月至6月研究随访及核查工作结束后统一锁定，由数据管理负责人和研究项目负责人执行。锁定操作在电子系统中完成，生成最终备份并存储于安全服务器。锁定前将进行全库备份，并生成锁定报告，记录锁定时间、操作人员及签名确认。锁定后数据不得再修改，仅供最终统计分析使用。

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

Data management in this study followed a strict step-by-step process. Firstly, data collection was performed by the surgeon, nursing staff and follow-up members at baseline before surgery, real-time during surgery, daily during postoperative hospitalization, and at 1, 3, 6, and 12 months after surgery. All original information was recorded in a paper standardized case report form (CRF), which was temporarily stored in the department or medical record room. Subsequently, it was entered into an Excel electronic database by a special person. If any collection error or omission is found, it will be re-verified and supplemented. The paper CRF was archived after input and review, and subsequently managed by the data manager without any changes. Second, data entry was completed within 1 to 3 working days by full-time data entry members in an encrypted electronic data acquisition system (Excel) with user rights management and log recording functions. If inputting errors or data discrepancies are found, they need to apply for correction through the challenge process. After the input, double review is carried out, and the data is temporarily locked after the review is passed. Subsequently, data challenge was initiated immediately after data entry and continued during follow-up, at least monthly, by data management and statisticians. The challenge process was completed in the challenge management module of the spreadsheet, and all queries and responses were recorded electronically. If abnormal values, logical conflicts or missing data are found, the system will automatically notify the relevant collection personnel, and the correction can only be made after confirmation. If the unsolved problems are not solved, the relevant fields will be suspended. Data modification must be completed within 3 working days after the query is received, and the original data collection personnel, data entry personnel, and data managers participate in the process. All changes are automatically logged in the electronic system and the reason for the change must be explained. Any modification must be approved, and no modification shall be made without approval. After the modification is completed, it must be resubmitted for review. Finally, data will be locked after the completion of study follow-up and verification, which is expected to occur from March to June 2028, and will be performed by the data management officer and the study director. The locking operation is completed in the electronic system, and a final backup is generated and stored on a secure server. Before locking, a full database backup will be performed and a locking report will be generated, recording the locking time, operator and signature confirmation. Data could not be modified after lock and were used only for the final statistical analysis.

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：

  2025-11-18 11:17:27