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Percutaneous cryoablation: An alternative treatment for breast cancer in elderly patients
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注册号：

Registration number：

 ChiCTR2100044587 

最近更新日期：

Date of Last Refreshed on：

 2021-03-24 04:28:28 

注册时间：

Date of Registration：

 2021-03-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Percutaneous cryoablation: An alternative treatment for breast cancer in elderly patients

Public title：

Percutaneous cryoablation: An alternative treatment for breast cancer in elderly patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Percutaneous cryoablation: An alternative treatment for breast cancer in elderly patients

Scientific title：

Percutaneous cryoablation: An alternative treatment for breast cancer in elderly patients

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：

Hung Ka Wai Ray 

研究负责人：

HUNG KA WAI RAY 

Applicant：

Hung Ka Wai Ray 

Study leader：

HUNG KA WAI RAY 

申请注册联系人电话：

Applicant telephone：

 +852 91616765

研究负责人电话：

Study leader's
telephone：

+852 91616765

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：

 hkw879@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 hkw879@ha.org.hk

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：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong, China

研究负责人通讯地址：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong, China

Applicant address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong, China

Study leader's address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong

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：

香港上水北區醫院

Applicant's institution：

North District Hospital

研究负责人所在单位：

香港上水北區醫院

Affiliation of the Leader：

North District 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：

 2020.646-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-03-09 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Ngan Shing Street, Shatin, N.T., Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

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：

Hung Ka Wai Ray

Primary sponsor：

Hung Ka Wai Ray

研究实施负责（组长）单位地址：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong, China

Primary sponsor's address：

Department of Surgery, 2/F, North District Hospital, Sheung Shui, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Breast Cancer  

Target disease：

Breast Cancer

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：

单臂 

Study design：

Single arm 

研究目的：

Breast cancer is the most common cancer in women. Although surgery is the standard of care, not all patients, especially the elderly are medically fit to undergo surgical excision. Hormonal treatment is an alternative for that but the local failure rate is up to 43% according to the literature. This study aimed to assess the treatment efficacy of the use of cryoablation for treatment of breast cancer in the elderly.  

Objectives of Study：

Breast cancer is the most common cancer in women. Although surgery is the standard of care, not all patients, especially the elderly are medically fit to undergo surgical excision. Hormonal treatment is an alternative for that but the local failure rate is up to 43% according to the literature. This study aimed to assess the treatment efficacy of the use of cryoablation for treatment of breast cancer in the elderly.

药物成份或治疗方案详述：

Pre-ablation assessment All patients confirmed to have breast cancer will be managed according to the departmental protocol. Surgery is the standard of treatment for all non-metastatic diseases. They will be recruited to the trial if they are not fit or refuse surgical intervention. The index lesion will be assessed for feasibility of treatment by target ultrasonography performed by surgeons. Multifocal disease, tumors larger than 2 cm in size or attaching to the skin will be excluded. A pre-ablation contrast breast MRI will be arranged for all patients enrolled to the trial. Ablation technique The procedure is performed under local anaesthesia and with day surgery. The tumor will be localized by ultrasonography and the longest dimension will be chosen as the longitudinal axis for the ablation probe to pass through. The entry site, the lesion and the path of probe insertion will be marked on skin. A stab incision will be made at the entry point after injection of local anaesthesia. The probe will then pierce through the lesion under real time ultrasound guidance with the tip located at around 2 cm from the center of the tumor and ablation will be started once the position is confirmed. Each treatment session consists of first freezing, thaw, second freezing and warming (double freezing method). During the freezing procedure, the probe is lifted up and shaken to prevent thermal injury to the chest wall. Injection of normal saline to the space between the skin and the subcutaneous fascia is carried out to avoid thermal injury to the skin. The size of the iceball will be monitored throughout the procedure and a minimum margin of 1 cm of adjacent tissue is obtained to ensure complete freezing of the tumor. Post-ablation follow up After the procedure, patients will be follow-up 24-48 hours for assessment of pain and local complications. If the tumor is hormonal sensitive, endocrine therapy will be given and continued after procedure. Subsequently, 3 monthly clinical assessments with target ultrasonography will be arranged until 1 year after the procedure. Size of the lesion will be recorded in each visit. A contrast breast MRI will be arranged 3 months after the procedure to assess the post-ablation radiological imaging. When the tumor and the iceball is shrinked to less than 2 cm, excision of the tumor with margin will be performed under local anesthesia for pathological assessment.  

Description for medicine or protocol of treatment in detail：

Pre-ablation assessment All patients confirmed to have breast cancer will be managed according to the departmental protocol. Surgery is the standard of treatment for all non-metastatic diseases. They will be recruited to the trial if they are not fit or refuse surgical intervention. The index lesion will be assessed for feasibility of treatment by target ultrasonography performed by surgeons. Multifocal disease, tumors larger than 2 cm in size or attaching to the skin will be excluded. A pre-ablation contrast breast MRI will be arranged for all patients enrolled to the trial. Ablation technique The procedure is performed under local anaesthesia and with day surgery. The tumor will be localized by ultrasonography and the longest dimension will be chosen as the longitudinal axis for the ablation probe to pass through. The entry site, the lesion and the path of probe insertion will be marked on skin. A stab incision will be made at the entry point after injection of local anaesthesia. The probe will then pierce through the lesion under real time ultrasound guidance with the tip located at around 2 cm from the center of the tumor and ablation will be started once the position is confirmed. Each treatment session consists of first freezing, thaw, second freezing and warming (double freezing method). During the freezing procedure, the probe is lifted up and shaken to prevent thermal injury to the chest wall. Injection of normal saline to the space between the skin and the subcutaneous fascia is carried out to avoid thermal injury to the skin. The size of the iceball will be monitored throughout the procedure and a minimum margin of 1 cm of adjacent tissue is obtained to ensure complete freezing of the tumor. Post-ablation follow up After the procedure, patients will be follow-up 24-48 hours for assessment of pain and local complications. If the tumor is hormonal sensitive, endocrine therapy will be given and continued after procedure. Subsequently, 3 monthly clinical assessments with target ultrasonography will be arranged until 1 year after the procedure. Size of the lesion will be recorded in each visit. A contrast breast MRI will be arranged 3 months after the procedure to assess the post-ablation radiological imaging. When the tumor and the iceball is shrinked to less than 2 cm, excision of the tumor with margin will be performed under local anesthesia for pathological assessment.  

纳入标准：

Inclusion criteria

排除标准：

Tumor size more than 2 cm.

Exclusion criteria：

Tumor size more than 2 cm.

研究实施时间：

Study execute time：

从 From 2021-03-15 00:00:00至 To 2023-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-03-15 00:00:00 至 To 2023-03-31 00:00:00

干预措施：

Interventions：

组别：

Breast cancer cases

样本量：

 30

Group：

Breast cancer cases

Sample size：

干预措施：

Cryoablation

干预措施代码：

Intervention：

Cryoablation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 上水北區醫院 

单位级别：

 三级醫院 

Institution
hospital：

North District Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Local control of tumor

指标类型：

主要指标

Outcome：

Local control of tumor

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：

组织：

Sample Name：

Breast lump

Tissue：

Post ablation lesion

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 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

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

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）：

N/A

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

N/A

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：

N/A

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

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-24 04:28:28
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