ChiCTR2500110457 版本V1.0 版本创建时间2025/10/14 11:42:44 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：

 ChiCTR2500110457 

最近更新日期：

Date of Last Refreshed on：

 2025-10-14 11:42:32 

注册时间：

Date of Registration：

 2025-10-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery

Public title：

Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery

Scientific title：

Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery

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：

Ip Ching Tak 

研究负责人：

Chok Siu Ho Kenneth 

Applicant：

Ip Ching Tak 

Study leader：

Chok Siu Ho Kenneth 

申请注册联系人电话：

Applicant telephone：

 +852 3505 2620

研究负责人电话：

Study leader's
telephone：

+852 3505 1496

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：

 philipip@surgery.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 kennethchok@surgery.cuhk.edu.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：

Rm 64005, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

研究负责人通讯地址：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Applicant address：

Rm 64005, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2025.486

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：

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

Name of the ethic committee：

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

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-02 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：

Joint CUHK-NTEC Clinical Research Ethics Committee, 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee, 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Primary sponsor's address：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

The Chinese University of Hong Kong

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

64042, 4/F, Department of Surgery, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Liver and pancreatic tumour, gallbladder stone and Mirizzi syndrome  

Target disease：

Liver and pancreatic tumour, gallbladder stone and Mirizzi syndrome

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The aim of this prospective study is to evaluate the clinical efficacy and safety of the Cornerstone Robotics Sentire Surgical System C1000 in performing major hepatobiliary and pancreatic robotic operations.  

Objectives of Study：

The aim of this prospective study is to evaluate the clinical efficacy and safety of the Cornerstone Robotics Sentire Surgical System C1000 in performing major hepatobiliary and pancreatic robotic operations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

General Inclusion Criteria for All Procedures 1. Body mass index <35 kg/m^2. 2. Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases. 3. Willingness to participate as demonstrated by giving informed consent. Procedure-Specific Criteria: Robotic partial hepatectomy Inclusion: 1.Primary liver malignancy, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, amenable to minimally invasive surgery. 2. Liver metastasis amendable to minimally invasive surgery. Robotic choledochochal cyst excision and hepatojejunostomy Inclusion: Type 1 and Type 4 choledochal cyst (Todani classification). Robotic Distal Pancreatectomy and Splenectomy (DPS) Inclusion: 1.Radiological or histology-proven adenocarcinoma of distal pancreas. 2.Radiological or histology-proven neuroendocrine tumor of distal pancreas. Robotic distal pancreatectomy with Splenic Vessels and spleen Preservation (SVP) Inclusion: Benign pancreatic neoplasm, including pancreatic cystic neoplasm and insulinoma. Robotic enucleation of pancreatic lesion Inclusion: Benign pancreatic neoplasm (insulinoma). Robotic Cholecystectomy with or without exploration of common bile duct Inclusion: 1. Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy. 2. Difficult choledocholithiasis: stone size > 1.5cm, and/or multiple stones > 3, and/or narrow and angled distal common bile duct (CBD) (< 135 degree). 3.Mirizzi syndrome.

Inclusion criteria

General Inclusion Criteria for All Procedures 1. Body mass index <35 kg/m^2. 2. Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases. 3. Willingness to participate as demonstrated by giving informed consent. Procedure-Specific Criteria: Robotic partial hepatectomy Inclusion: 1.Primary liver malignancy, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, amenable to minimally invasive surgery. 2. Liver metastasis amendable to minimally invasive surgery. Robotic choledochochal cyst excision and hepatojejunostomy Inclusion: Type 1 and Type 4 choledochal cyst (Todani classification). Robotic Distal Pancreatectomy and Splenectomy (DPS) Inclusion: 1.Radiological or histology-proven adenocarcinoma of distal pancreas. 2.Radiological or histology-proven neuroendocrine tumor of distal pancreas. Robotic distal pancreatectomy with Splenic Vessels and spleen Preservation (SVP) Inclusion: Benign pancreatic neoplasm, including pancreatic cystic neoplasm and insulinoma. Robotic enucleation of pancreatic lesion Inclusion: Benign pancreatic neoplasm (insulinoma). Robotic Cholecystectomy with or without exploration of common bile duct Inclusion: 1. Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy. 2. Difficult choledocholithiasis: stone size > 1.5cm, and/or multiple stones > 3, and/or narrow and angled distal common bile duct (CBD) (< 135 degree). 3.Mirizzi syndrome.

排除标准：

General Exclusion Criteria for All Procedures 1. Contraindication to general anesthesia. 2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention. 3. Untreated active infection. 4. Noncorrectable coagulopathy. 5. Presence of another malignancy or distant metastasis. 6. Emergency surgery. 7. Vulnerable population (e.g., mentally disabled, pregnancy). Procedure-Specific Criteria Robotic partial hepatectomy Exclusion: 1. Presence of inoperable primary tumor or extra-hepatic disease involvement; 2.Patients with advanced cirrhosis and/or portal hypertension ; 3.Extensive previous abdominal surgery precluding minimally invasive surgery. Robotic choledochochal cyst excision and hepatojejunostomy Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic Distal Pancreatectomy and Splenectomy (DPS) Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic distal pancreatectomy with Splenic Vessels and spleen Preservation (SVP) Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic enucleation of pancreatic lesion Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic Cholecystectomy with or without exploration of common bile duct Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery.

Exclusion criteria：

General Exclusion Criteria for All Procedures 1. Contraindication to general anesthesia. 2. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention. 3. Untreated active infection. 4. Noncorrectable coagulopathy. 5. Presence of another malignancy or distant metastasis. 6. Emergency surgery. 7. Vulnerable population (e.g., mentally disabled, pregnancy). Procedure-Specific Criteria Robotic partial hepatectomy Exclusion: 1. Presence of inoperable primary tumor or extra-hepatic disease involvement; 2.Patients with advanced cirrhosis and/or portal hypertension ; 3.Extensive previous abdominal surgery precluding minimally invasive surgery. Robotic choledochochal cyst excision and hepatojejunostomy Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic Distal Pancreatectomy and Splenectomy (DPS) Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic distal pancreatectomy with Splenic Vessels and spleen Preservation (SVP) Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic enucleation of pancreatic lesion Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery. Robotic Cholecystectomy with or without exploration of common bile duct Exclusion: extensive previous abdominal surgery precluding minimally invasive surgery.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2025-10-20 00:00:00 至 To 2027-09-15 00:00:00

干预措施：

Interventions：

组别：

Robotic surgery group

样本量：

 90

Group：

Robotic surgery group

Sample size：

干预措施：

Using Cornerstone Robotics Sentire Surgical System C1000 to perform major hepatobiliary and pancreatic robotic operations.

干预措施代码：

Intervention：

Using Cornerstone Robotics Sentire Surgical System C1000 to perform major hepatobiliary and pancreatic robotic operations.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 NA 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

Rate of conversions to open surgery

指标类型：

主要指标

Outcome：

Rate of conversions to open surgery

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Perioperative complications

指标类型：

主要指标

Outcome：

Perioperative complications

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Operative time

指标类型：

次要指标

Outcome：

Operative time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood loss during operation

指标类型：

次要指标

Outcome：

Blood loss during operation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Length of hospital stay

指标类型：

次要指标

Outcome：

Length of hospital stay

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：

NA

组织：

Sample Name：

NA

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：

尚未开始

Not yet recruiting

年龄范围：

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

None

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

None

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

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）：

None

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

None

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：

All data will be collected by authorized research staff in well designed CRF. All information collected in this study will be kept strictly confidential and will be stored in a password-encrypted computer system for 5 years. All the information and data collected in this study will be permanently deleted afterwards. Only the study investigators have rights to access the information.

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

All data will be collected by authorized research staff in well designed CRF. All information collected in this study will be kept strictly confidential and will be stored in a password-encrypted computer system for 5 years. All the information and data collected in this study will be permanently deleted afterwards. Only the study investigators have rights to access the information.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-10-14 11:42:32