【ChiCTR2500110457】Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery

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基本信息

登记号

ChiCTR2500110457

试验状态

尚未开始

药物名称

腔镜手术机器人

药物类型

规范名称

首次公示信息日的期

2025-10-14

临床申请受理号

靶点

适应症

Liver and pancreatic tumour, gallbladder stone and Mirizzi syndrome

试验通俗题目

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

试验专业题目

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

申办单位信息

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临床试验信息

试验目的

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.

试验分类

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试验类型

单臂

试验分期

其它

随机化

None

盲法

试验项目经费来源

None

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-10-01

试验终止时间

2027-10-01

是否属于一致性

入选标准

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.；

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.；

研究者信息

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试验机构

The Chinese University of Hong Kong

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