ChiCTR2400092783 版本V1.0 版本创建时间2024/11/22 15:54:55 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：

 ChiCTR2400092783 

最近更新日期：

Date of Last Refreshed on：

 2024-11-22 15:54:49 

注册时间：

Date of Registration：

 2024-11-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

亚肝段射频消融治疗原发性肝癌的临床研究

Public title：

The clinical research of subhepatic radiofrequency ablation for primary hepatocellular carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

亚肝段射频消融治疗原发性肝癌的临床研究

Scientific title：

The clinical research of subhepatic radiofrequency ablation for primary hepatocellular carcinoma

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：

李长峰 

研究负责人：

毕华强 

Applicant：

Changfeng Li 

Study leader：

Huaqiang Bi 

申请注册联系人电话：

Applicant telephone：

 +86 153 4041 4511

研究负责人电话：

Study leader's
telephone：

+86 139 9614 1977

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：

 changfeng.Li2020@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

 psycho_med@sina.com

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：

重庆市沙坪坝区高滩岩正街29号

研究负责人通讯地址：

重庆市沙坪坝区高滩岩正街29号

Applicant address：

No. 29, Gaotanyanzheng Street, Shapingba District, Chongqing

Study leader's address：

No. 29, Gaotanyanzheng Street, Shapingba District, Chongqing

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：

陆军军医大学附属西南医院全军肝胆外科研究所

Applicant's institution：

Institution of Hepatobiliary Surgery, Southwest Hospital, Army Medical University

研究负责人所在单位：

陆军军医大学附属西南医院全军肝胆外科研究所

Affiliation of the Leader：

Institution of Hepatobiliary Surgery, Southwest Hospital, Army Medical University

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：

 (A)KY2022152

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：

中国人民解放军陆军军医大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-30 00:00:00

伦理委员会联系人：

毛青

Contact Name of the ethic committee：

Qing Mao

伦理委员会联系地址：

重庆市沙坪坝区高滩岩正街29号

Contact Address of the ethic committee：

No. 29, Gaotanyanzheng Street, Shapingba District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 23 6875 4035

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：

陆军军医大学附属西南医院

Primary sponsor：

Southwest Hospital, Army Medical University

研究实施负责（组长）单位地址：

重庆市沙坪坝区高滩岩正街29号

Primary sponsor's address：

No. 29, Gaotanyanzheng Street, Shapingba District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

陆军军医大学附属西南医院

具体地址：

重庆市沙坪坝区高滩岩正街29号

Institution
hospital：

Southwest Hospital, Army Medical University

Address：

No. 29, Gaotanyanzheng Street, Shapingba District, Chongqing

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

肝细胞肝癌  

Target disease：

Hepatocellular carcinoma

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1、以前瞻性研究为主要方法,观察亚肝段射频消融（subhepatic Radiofrequency ablation, SRFA）治疗原发性肝癌2年的无复发生存期（Recurrence-free survival, RFS）和总生存期（Overall survival, OS）,将其与常规射频消融（Radiofrequency ablation, RFA）治疗的近期疗效进行对比。 2、评估亚肝段射频消融疗法相对于常规射频消融治疗原发性肝癌的价值,以及该疗法的安全性和有效性。  

Objectives of Study：

1.With prospective study as the main method, the 2-year recurrence-free survival and overall survival of subhepatic radiofrequency ablation for primary liver cancer were observed, and the short-term efficacy of subhepatic radiofrequency ablation was compared with that of radiofrequency ablation. 2.To evaluate the value of subhepatic radiofrequency ablation compared with radiofrequency ablation in the treatment of primary liver cancer, as well as the safety and efficacy of this therapy.

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）研究对象理解研究内容及意义，获得书面知情同意书； 2）性别不限，年龄≥18周岁，≤75周岁； 3）有HCC切除或RFA病史，且按美国ASSLD标准获得HCC的临床或病理诊断；病灶数量1个；最大病灶≤3cm，以增强CT或增强MRI为标准； 4）不可或不愿再次行切除手术的患者； 5） Child Pugh A（≤7分）级，无需要治疗的胸腹水和肝性脑病；美国东部肿瘤协作组（ECOG）行为状态评分为0-1； 6）在入组前7天内，有足够的肝肾功能，合适的实验室指标（未经处理）：血红蛋白含量 ( hemoglobin, HGB)≥9.0g/dl，中性粒细胞≥1,500/mm3，PLT≥50×109/L，血清ALB≥28g/L，TBIL<50umol/L，ALT、AST< 5倍正常值上限值，Bun、Cr<1.5倍的正常上限值，INR<1.7或PT延长<4s； 7）瘤体位于肝实质内，有经肝实质的进针路径，周围无大血管、胆管及重要脏器； 8）术前未接受其他抗肿瘤治疗。

Inclusion criteria

1.The research object understands the research content and significance, and obtains written informed consent; 2.Gender is not limited, age ≥ 18 years old, ≤ 75 years old; 3.Patients had a history of HCC resection or RFA, and the clinical or pathological diagnosis of HCC was obtained according to the American ASSLD standard. The number of lesions was 1; the maximum lesion ≤ 3cm, with enhanced CT or enhanced MRI as the standard; 4.Patients who could not or did not want to undergo resection again; 5.Child Pugh A (≤ 7 points), no need for treatment of pleural effusion and ascites and hepatic encephalopathy; the Eastern Cooperative Oncology Group (ECOG) behavioral status score was 0-1; 6.Within 7 days before enrollment, there were enough liver and kidney function, appropriate laboratory indicators ( untreated ) : hemoglobin ( HGB ) ≥ 9.0g / dl, neutrophils ≥ 1,500 / mm3, PLT ≥ 50 × 109 / L, serum ALB ≥ 28g / L, TBIL < 50umol / L, ALT, AST < 5 times the upper limit of normal value, Bun, Cr < 1.5 times the upper limit of normal value, INR < 1.7 or PT extension < 4s; 7.The tumor was located in the liver parenchyma, and there was a needle path through the liver parenchyma. There were no large blood vessels, bile ducts and important organs around the tumor; 8.No other anti-tumor treatment was received before operation.

排除标准：

1）严重的心肺疾病；出、凝血功能障碍；门静脉高压症；妊娠； 2）ASA评分：>3分； 3）癫痫、精神病患者； 4）术前影像学提示病灶靠近肝脏表面、胆囊、肝门部重要血管、胆管及周围重要脏器等，预计手术可能会造成严重的误损伤及严重并发症； 5）明确的肝外转移及肝脏脉管癌栓。

Exclusion criteria：

1.Serious heart and lung disease ; bleeding, coagulation dysfunction; portal hypertension; pregnancy; 2.ASA score: > 3; 3.Epilepsy, psychiatric patients; 4.Preoperative imaging showed that the lesion was close to the surface of the liver, gallbladder, important blood vessels in the hepatic portal, bile duct and surrounding important organs. It is expected that the operation may cause serious accidental injury and serious complications; 5.Clear extrahepatic metastasis and hepatic vascular tumor thrombus.

研究实施时间：

Study execute time：

从 From 2023-03-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-01 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 100

Group：

Experimental group

Sample size：

干预措施：

通过术前CT肝血管3D成像及彩色多普勒超声，高选择性寻找并定位荷瘤的亚肝段肝蒂，通过射频消融技术进行损毁，阻断肿瘤的门静脉血供。同时，还通过彩色多普勒超声实时监测毁损效果；独创金字塔形三维立体消融，多针多层多角度全方位损毁荷瘤的亚肝段门静脉流域的肝实质，最大限度地保证射频消融的损毁范围效果。

干预措施代码：

Intervention：

Through preoperative CT hepatic vascular 3D imaging and color Doppler ultrasound, the subsegmental hepatic pedicle of the tumor-bearing liver was highly selectively searched and located, and the portal vein blood supply of the tumor was blocked by radiofrequency ablation. At the same time, the damage effect was monitored in real time by color Doppler ultrasound. The original pyramid-shaped three-dimensional ablation, multi-needle multi-layer multi-angle all-round damage to the liver parenchyma of the tumor-bearing sub-hepatic portal vein basin, to maximize the effect of radiofrequency ablation damage range.

Intervention code：

组别：

对照组

样本量：

 100

Group：

Control group

Sample size：

干预措施：

采用常规方式，超声引导下电极针直接穿刺进入肿瘤进行射频消融。

干预措施代码：

Intervention：

Ultrasound-guided electrode needle was directly punctured into the tumor for radiofrequency ablation in a conventional way.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 中国人民解放军陆军军医大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Army Medical University, PLA

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

2年总体生存期

指标类型：

主要指标

Outcome：

2-year overall survival

Type：

Primary indicator

测量时间点：

术后每三月测量一次，至术后2年

测量方法：

门诊随访，确认患者是否存活

Measure time point of outcome：

The measurement was performed every three months until 2 years after operation.

Measure method：

Outpatient follow-up to confirm whether the patient survived

指标中文名：

2年无复发生存期

指标类型：

主要指标

Outcome：

2-year recurrence-free survival

Type：

Primary indicator

测量时间点：

术后每三月测量一次，至术后2年

测量方法：

门诊随访，评估肿瘤是否复发

Measure time point of outcome：

The measurement was performed every three months until 2 years after operation.

Measure method：

Outpatient follow-up to assess whether the tumor recurrence.

指标中文名：

术后并发症

指标类型：

次要指标

Outcome：

postoperative complication

Type：

Secondary indicator

测量时间点：

术后至出院3月内

测量方法：

Measure time point of outcome：

Within 3 months after operation to discharge

Measure method：

指标中文名：

术后肝功能

指标类型：

次要指标

Outcome：

Postoperative liver function

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：

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：

正在进行

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）：

不适用

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

N/A

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

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）：

于2027.01将该临床试验原始数据公布于临床试验公共管理平台 ResMan

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

The original data of the clinical trial were published on the clinical trial public management platform ResMan in 2027.01

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：

筛选合格获得患者编号者填写正式病例报告表，所有参加研究的患者均需完整填写他们的病例报告表，只有研究者方可签署病例报告表。病例报告表第二联由各研究中心保存；第一联用于统计分析，并最终由申办方保存。同时将所有研究相关的受试者数据均记录在eCRF中，研究者负责通过在eCRF上进行电子签名核实数据录入准确、正确。本研究生成的所有数据均将在重庆和平新健康科技有限公司的专病管理系统中进行保存。

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

Qualified patients were screened to fill in the formal case report form. All patients participating in the study were required to complete their case report form, and only the researchers could sign the case report form. The second case report form was saved by the research center; the first couplet is used for statistical analysis and is eventually saved by the bidder. At the same time, all the subjects ' data related to the study were recorded in the eCRF, and the researchers were responsible for verifying the accuracy and correctness of the data entry by electronic signature on the eCRF. All data generated in this study will be stored in the special disease management system of Chongqing Pharmaceutical Group Peace New HEALTH Technology Co., Ltd.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-11-22 15:54:50