Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Pancreatic fistula rate
研究概览
简要总结
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors
详细描述
The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Body Mass Index<30
- •Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
- •Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
- •largest diameter < 4cm
- •Preoperative CT showed no evidence that tumor was connected with main pancreatic duct
排除标准
- •Severe cardio/pulmonary complications
- •Other pancreatic diseases, including pancreatitis and pancreatic cancer
- •Multiple pancreatic neuroendocrine tumors
- •Distant metastasis
研究组 & 干预措施
Open surgery
Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100
干预措施: Open surgery (Procedure)
robotic arm
robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
干预措施: Robotic surgery (Procedure)
Laparoscopic surgery
laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
干预措施: Laparoscopic surgery (Procedure)
结局指标
主要结局
Pancreatic fistula rate
时间窗: up to 30 days
次要结局
- Mortality rate(up to 30 days)