ChiCTR1900021409 版本V1.0 版本创建时间2019/02/24 17:52:37 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：

ChiCTR1900021409 

最近更新日期：

Date of Last Refreshed on：

2019-02-19 23:12:29 

注册时间：

Date of Registration：

2019-02-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

腔内激光联合泡沫硬化剂治疗下肢静脉曲张的疗效分析

Public title：

Efficacy of endovenous laser combined with sclerosing foam in the treatment of varicose veins of the lower extremities

注册题目简写：

English Acronym：

研究课题的正式科学名称：

腔内激光联合泡沫硬化剂治疗下肢静脉曲张的疗效分析

Scientific title：

Efficacy of endovenous laser combined with sclerosing foam in the treatment of varicose veins of the lower extremities

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：

孟庆义 

研究负责人：

孟庆义 

Applicant：

Qing-Yi Meng 

Study leader：

Qing-Yi Meng 

申请注册联系人电话：

Applicant telephone：

+86 13370582128

研究负责人电话：

Study leader's telephone：

+86 13370582128

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：

1543864012@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1543864012@qq.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：

山东省济南市历下区解放路105号山东省济南市中心医院

研究负责人通讯地址：

山东省济南市历下区解放路105号

Applicant address：

105 Jiefang Road, Ji'nan, Shandong, China

Study leader's address：

105 Jiefang Road, Ji'nan, Shandong, China

申请注册联系人邮政编码：

Applicant postcode：

250013

研究负责人邮政编码：

Study leader's postcode：

250013

申请人所在单位：

山东省济南市中心医院

Applicant's institution：

Ji'nan Central Hospital of Shandong University

研究负责人所在单位：

山东省济南市中心医院

Affiliation of the Leader：

Ji'nan Central Hospital of Shandong 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：

2016-054-01

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：

济南市中心医院伦理委员会

Name of the ethic committee：

Jinan Central Hospital ethic committee

伦理委员会批准日期：

Date of approved by ethic committee：

1990-01-01 00:00:00

伦理委员会联系人：

孟庆义

Contact Name of the ethic committee：

Qing-Yi Meng

伦理委员会联系地址：

山东省济南市历下区解放路105号山东省济南市中心医院

Contact Address of the ethic committee：

Ji'nan Central Hospital of Shandong University, 105 Jiefang Road, Ji'nan, Shandong, 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：

山东省济南市中心医院

Primary sponsor：

Ji'nan Central Hospital of Shandong University

研究实施负责（组长）单位地址：

山东省济南市历下区解放路105号

Primary sponsor's address：

105 Jiefang Road, Ji'nan, Shandong, 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)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Ji'nan

单位(医院)：

山东省济南市中心医院

具体地址：

山东省济南市历下区解放路105号山东省济南市中心医院

Institution
hospital：

Ji'nan Central Hospital of Shandong University

Address：

105 Jiefang Road, Ji'nan, Shandong, China

经费或物资来源：

自费

Source(s) of funding：

self-paying

Target disease：

varicose veins of the lower extremities

Target disease code：

研究类型：

观察性研究

Study type：

Observational 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：

单臂 

Study design：

Single arm 

研究目的：

对零切口腔内激光联合硬化剂治疗下肢静脉曲张的疗效进行研究  

Objectives of Study：

This study aims to investigate the efficacy of incision-free endovenous laser treatment (EVLT) combined with sclerosing foam in the treatment of varicose veins of the lower extremities (VVLE)

药物成份或治疗方案详述：

患者取平卧位，全麻成功后，消毒铺巾，应用Seldinger穿刺技术穿刺内踝前方大隐静脉起始处，后引入激光光纤，将光纤头端引入腹股沟区大隐静脉汇入股静脉下约一横指处，启动激光放电装置，激光功率为16W，激光能量为6000J，以0.5-1cm/s的速度移动激光导丝，直至将大隐静脉主干膝上段完全闭塞，至此退出激光导丝。对于膝下小腿段分支曲张静脉及溃疡面的处理采用头皮针多点穿刺注入聚桂醇泡沫硬化剂（陕西天宇制药有限公司 国药准字H20080445）的方法。泡沫硬化剂的制备采用Tessari法，即将两个10ml空注射器用三通阀连接，分别抽取2ml聚桂醇注射液和6ml空气，快速交换推注注射器内的药液与气体混合约20次,在完成前10次交换后将三通阀尽可能关小，由此得到8ml泡沫硬化剂。根据术前标记确定穿刺点,使用头皮针穿刺曲张静脉,待头皮针内回血后，由近端向远端推注，注射2-3 mL聚桂醇泡沫硬化剂到曲张静脉腔内，待曲张静脉变硬后更换注射点，每例患者聚桂醇注射液单次使用量一般不得超过10ml。注射完成后，再一次消毒各个穿刺点，立即佩戴医用弹力袜，并使用自粘绷带自踝部至腹股沟区加压包扎。 

Description for medicine or protocol of treatment in detail：

Patients were placed in the supine position. After the success of the general anesthesia, routine disinfection was performed and surgical drapes were placed. The Seldinger technique was used to puncture at the beginning of the great saphenous vein, before the medial malleolus. Then, a laser optical fiber was introduced, and the head of the optic fiber was inserted into the great saphenous vein in the inguinal area at the site one transverse finger long below the confluence site with the femoral vein. The discharge device of the laser instrument was started with a laser power of 16 W and a laser energy level of 6000 J. The laser guide wire was moved at a speed of 0.5-1 cm/s, until the upper part of the trunk of the great saphenous vein was completely obliterated. At that time, the laser guide wire was withdrawn . Varicose branch veins and ulcers in the lower leg were treated with multiple-site puncture with scalp acupuncture and injected with the lauromacrogol sclerosing foam (Shaanxi Tianyu Pharmaceutical Co., Ltd.; H20080445). The sclerosing foam was prepared using the Tessari method , that is, two 10-ml empty syringes are connected by a three-way valve, in which 2 ml of lauromacrogol and 6 ml of air were extracted, respectively. Then, the pistons of the two syringes were rapidly and alternatively pushed to mix the liquid and gas approximately 20 times, where the three-way valve was turned down as much as possible after 10 times of mixing, thereby allowing 8 ml of sclerosing foam to be obtained. Through the puncture sites that were determined and marked before the operation, the varicose vein was punctured using a scalp needle. After the scalp needle presented with blood returning, the piston was pushed from the proximal end to the distal end, and 2-3 mL of lauromacrogol sclerosing foam was injected into the lumen of the varicose vein. After the varicose vein hardened, the injection point was altered. The single use of lauromacrogol injection in each patient was generally not more than 10 mL . After the injection, each puncture site was sterilized again. Then, medical elastic stockings were immediately worn, and a compression bandage was applied to the area from the ankle to the inguinal region with self-adhesive bandage. 

纳入标准：

根据CEAP分级，静脉曲张临床分级C2—C6的患者

Inclusion criteria

patients with CEAP C2-C6 of varicose veins

排除标准：

1.既往有下肢深静脉血栓形成病史或正患有下肢深静脉血栓形成病的患者。2.近6个月内有心梗、肺栓塞、卒中病史的患者。3.近6个月内有重大手术史的患者.4.有严重的肾功能、肝功能障碍的患者。5.Cockett综合征的患者。6.正在孕期及哺乳期的患者。7.硬化剂过敏的患者

Exclusion criteria：

(1) patients with a history of deep venous thrombosis of the lower extremities or patients who presently have deep venous thrombosis of the lower extremities;
(2) patients with a history of myocardial infarction, pulmonary embolism and stroke in the past six months;
(3) patients with a history of major surgery in the past six months;
(4) patients with severe kidney and liver dysfunction;
(5) patients with Cockett syndrome;
(6) patients who are pregnant and lactating patients;
(7) patients allergic to the sclerosing agent. This study was conducted with approval from the Ethics Committee of our hospital.

研究实施时间：

Study execute time：

从 From 2016-10-01 00:00:00至 To 2017-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2016-10-01 00:00:00 至 To 2017-03-01 00:00:00  

干预措施：

Interventions：

组别：

Case series

样本量：

186

Group：

Case series

Sample size：

干预措施：

激光联合硬化剂

干预措施代码：

Intervention：

endovenous laser treatment combined with sclerosing foam in the treatment of varicose veins of the lower extremities

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

山东大学附属济南市中心医院 

单位级别：

三甲医院 

Institution
hospital：

Ji'nan Central Hospital of Shandong University

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

曲张静脉是否治愈

指标类型：

主要指标

Outcome：

the cure of the varicose veins

Type：

Primary indicator

测量时间点：

术后1周，1月，3月及6月

测量方法：

多普勒超声

Measure time point of outcome：

The time point was one week, one month, and three months after the operation

Measure method：

Doppler ultrasound

指标中文名：

溃疡面愈合情况

指标类型：

主要指标

Outcome：

the healing of the ulcer surface

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

每条患肢的手术时间

指标类型：

次要指标

Outcome：

The operation time of each affected limb

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

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 28 岁 years
最大 Max age 76 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）：

N/A

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：

N/A

Blinding：

N/A

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）：

通过电话邮箱联系作者; ResMan

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

contact the author by phone or email; ResMan

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：

病历记录表

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-02-19 23:12:29