ChiCTR2500110457尚未招募Unknown
Prospective Evaluation of Cornerstone Robotics Sentire Surgical System in Major Hepatobiliary and Pancreatic surgery
未提供1 个研究点 分布在 1 个国家开始时间: 2025年10月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 试验地点
- 1
- 主要终点
- Rate of conversions to open surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 单臂
入排标准
- 性别
- All
入选标准
- •General Inclusion Criteria for All Procedures
- •Body mass index <35 kg/m^
- •Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases.
- •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.
- •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:
- •Symptomatic gallbladder stones clinically indicated for laparoscopic cholecystectomy.
- •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
- •Contraindication to general anesthesia.
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention.
- •Untreated active infection.
- •Noncorrectable coagulopathy.
- •Presence of another malignancy or distant metastasis.
- •Emergency surgery.
- •Vulnerable population (e.g., mentally disabled, pregnancy).
- •Procedure-Specific Criteria
- •Robotic partial hepatectomy Exclusion:
- •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.
研究组 & 干预措施
Robotic surgery group
结局指标
主要结局
Rate of conversions to open surgery
Perioperative complications
次要结局
- Operative time
- Blood loss during operation
- Length of hospital stay
研究者
研究点 (1)
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