ChiCTR2100044823 版本V1.0 版本创建时间2021/10/25 21:07:57 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：

 ChiCTR2100044823 

最近更新日期：

Date of Last Refreshed on：

 2021-03-28 02:38:14 

注册时间：

Date of Registration：

 2021-03-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Expanding donor pool for live donor liver transplantation: Utilization of donors with NASH after optimization

Public title：

Expanding donor pool for live donor liver transplantation: Utilization of donors with NASH after optimization

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Expanding donor pool for live donor liver transplantation: Utilization of donors with NASH after optimization

Scientific title：

Expanding donor pool for live donor liver transplantation: Utilization of donors with NASH after optimization

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：

viniyendra pamecha 

研究负责人：

viniyendra pamecha 

Applicant：

viniyendra pamecha 

Study leader：

viniyendra pamecha 

申请注册联系人电话：

Applicant telephone：

 +91 95 40946803

研究负责人电话：

Study leader's
telephone：

+91 95 40946803

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：

 viniyendra@yahoo.co.uk

研究负责人电子邮件：

Study leader's E-mail：

 viniyendra@yahoo.co.uk

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：

Institute of Liver & Biliary Sciences, D-1, Acharya Shree Tulsi Marg, Vasant Kunj, New Delhi, India

研究负责人通讯地址：

Institute of Liver & Biliary Sciences, D-1, Acharya Shree Tulsi Marg, Vasant Kunj, New Delhi, India

Applicant address：

Institute of Liver & Biliary Sciences, D-1, Acharya Shree Tulsi Marg, Vasant Kunj, New Delhi, India

Study leader's address：

Institute of Liver & Biliary Sciences, D-1, Acharya Shree Tulsi Marg, Vasant Kunj, New Delhi, India

申请注册联系人邮政编码：

Applicant postcode：

 110070

研究负责人邮政编码：

Study leader's postcode：

 110070

申请人所在单位：

印度新德里肝胆科学研究所

Applicant's institution：

Institute of Liver & Biliary Sciences

研究负责人所在单位：

印度新德里肝胆科学研究所

Affiliation of the Leader：

Institute of Liver & Biliary Sciences

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：

 IEC/2020/81/NA01

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：

Institutional Ethics Committee (IEC) / Institutional Review Board (IRB), ILBS, New Delhi, India

Name of the ethic committee：

Institutional Ethics Committee (IEC) / Institutional Review Board (IRB), ILBS, New Delhi, India

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-08-27 00:00:00

伦理委员会联系人：

Institutional Ethics Committee (IEC) / Institutional Review Board (IRB), ILBS, New Delhi, India

Contact Name of the ethic committee：

Institutional Ethics Committee (IEC) / Institutional Review Board (IRB), ILBS, New Delhi, India

伦理委员会联系地址：

D-1, Vasant Kunj, New Delhi, India, 110070

Contact Address of the ethic committee：

D-1, Vasant Kunj, New Delhi, India, 110070

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +91 95 46300000

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ethics@ilbs.in

研究实施负责（组长）单位：

not applicable

Primary sponsor：

not applicable

研究实施负责（组长）单位地址：

not applicable

Primary sponsor's address：

not applicable

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

no source of support

Source(s) of funding：

no source of support

研究疾病：

live liver donors (LLDs) with and without non-alcoholic steatohepatitis  

Target disease：

live liver donors (LLDs) with and without non-alcoholic steatohepatitis

研究疾病代码：

Target disease code：

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

Primary objective: - To study the effect of donor optimization protocol in donors with biopsy proven NASH - To study the biochemical (LFTSs & INR) recovery in donors with NASH after major hepatectomy - To compare their biochemical recovery parameters (LFTs & INR) with that of non NASH donors. Secondary objectives: - To study incidence of NASH among live liver donors - To study their respective recipients outcomes - To study the morbidity among LLDs with NASH after major hepatectomy  

Objectives of Study：

Primary objective: - To study the effect of donor optimization protocol in donors with biopsy proven NASH - To study the biochemical (LFTSs & INR) recovery in donors with NASH after major hepatectomy - To compare their biochemical recovery parameters (LFTs & INR) with that of non NASH donors. Secondary objectives: - To study incidence of NASH among live liver donors - To study their respective recipients outcomes - To study the morbidity among LLDs with NASH after major hepatectomy

药物成份或治疗方案详述：

Donors with >20% steatosis and NASH with/without fibrosis on liver biopsy were advised to follow the donor optimization protocol for weight reduction. Subjects with≥ grade 2 fibrosis were rejected for donation. Our donor optimization protocolincludes: (1) Lifestyle modifications: stop smoking and consumption of junk foods and alcohol, regular small meals (4 to 5 meals per day), low fat (<30% of total calories) and low carbohydrate diet (40 to 50 % of total calories). (2) Dietary modifications: 1200 – 1600 Kcal/day and 50-60grams of proteins/day, avoid animal fat and ghee. (3) Exercise regimen: 40-60 minutes of moderate activity in the form of brisk walking or jogging every day. These donors were motivated and followed up weekly during the process of weight reduction. LFTs were repeated after the target weight reduction of ≥5%. If the LFTs were within the normal range, a second liver biopsy was performed. These donors were considered for the donation if the repeat liver biopsy reveals <20% steatosis and complete reversal of NASH, otherwise they were advised to continue the donor optimization protocol. 

Description for medicine or protocol of treatment in detail：

Donors with >20% steatosis and NASH with/without fibrosis on liver biopsy were advised to follow the donor optimization protocol for weight reduction. Subjects with≥ grade 2 fibrosis were rejected for donation. Our donor optimization protocolincludes: (1) Lifestyle modifications: stop smoking and consumption of junk foods and alcohol, regular small meals (4 to 5 meals per day), low fat (<30% of total calories) and low carbohydrate diet (40 to 50 % of total calories). (2) Dietary modifications: 1200 – 1600 Kcal/day and 50-60grams of proteins/day, avoid animal fat and ghee. (3) Exercise regimen: 40-60 minutes of moderate activity in the form of brisk walking or jogging every day. These donors were motivated and followed up weekly during the process of weight reduction. LFTs were repeated after the target weight reduction of ≥5%. If the LFTs were within the normal range, a second liver biopsy was performed. These donors were considered for the donation if the repeat liver biopsy reveals <20% steatosis and complete reversal of NASH, otherwise they were advised to continue the donor optimization protocol. 

纳入标准：

Live liver donors (LLDs) who had undergone major hepatectomy (removal of >=3 liver segments).

Inclusion criteria

Live liver donors (LLDs) who had undergone major hepatectomy (removal of >=3 liver segments).

排除标准：

- LLDs who had undergone minor hepatectomy (removal of < 3 liver segments);
- LLDs of recipients with acute liver failure.

Exclusion criteria：

- LLDs who had undergone minor hepatectomy (removal of < 3 liver segments);
- LLDs of recipients with acute liver failure.

研究实施时间：

Study execute time：

从 From 2011-06-01 00:00:00至 To 2018-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2011-06-01 00:00:00 至 To 2018-01-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 410

Group：

Case series

Sample size：

干预措施：

No

干预措施代码：

Intervention：

No

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度

省(直辖市)：

 新德里 

市(区县)：

  

Country：

India

Province：

New Delhi

City：

单位(医院)：

 印度新德里肝胆科学研究所 

单位级别：

  

Institution
hospital：

ILBS

Level of the institution：

测量指标：

Outcomes：

指标中文名：

To study the effect of donor optimization protocol in donors with biopsy proven NASH and To study their biochemical (LFTSs & INR) recovery after major hepatectomy

指标类型：

主要指标

Outcome：

To study the effect of donor optimization protocol in donors with biopsy proven NASH and To study their biochemical (LFTSs & INR) recovery after major hepatectomy

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：

Liver biopsy

组织：

Sample Name：

Liver biopsy

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 50 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）：

No

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

Not applicable

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：

N/A

Blinding：

Not applicable

是否共享原始数据：

IPD sharing

否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）：

N/A

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

not applicable

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：

not applicable

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-03-28 02:38:14