Comparison Between Robotic and Laparoscopic Surgery for Patients With Pancreatic Cystic Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Complication Rate
研究概览
简要总结
Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Conventionally, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail. In the ear of minimally invasive pancreatic surgery, when compared with open surgery, laparoscopic technology or Da Vinci robotic technology can avoid some open procedures limitations.
Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures.
详细描述
Background: Pancreatic cystic neoplasm (PCN) is a type of neoplastic lesion formed by the proliferation of pancreatic duct or acinar epithelial cells and retention of pancreatic secretions. Its heterogeneity is large, which can be benign, borderline, and poor differentiation and even evolve into pancreatic cancer. The tumor can be located in the head and neck of the pancreas or the body and tail of the pancreas. Some patients may be accompanied by recurrent pancreatitis, abdominal pain, nausea, vomiting, jaundice, and other gastrointestinal symptoms, usually with the help of abdominal ultrasound and endoscopy, ERCP, CT, nuclear magnetic, or MRCP imaging The examination can diagnose the disease. For PCN patients with large tumors, risk of malignant transformation, and accompanying symptoms that affect the quality of life, surgery is an effective treatment.
Based on the conventional routine treatment, open pancreaticoduodenectomy or open distal pancreatectomy was performed for patients with PCN locates either at the head or tail.
After more than 20 years of development, minimally invasive pancreatic surgery technology can be divided into two categories: laparoscopic technology and Da Vinci robotic technology. In general, compared with open surgery, minimally invasive pancreatic surgery technology can avoid some open procedures limitations, reduce the loss of intraoperative body fluid and its impact on the internal environment, and avoid excessive disturbance to other abdominal organs. It also helps reduce the pain of patients and shorten the length of hospital stay. Because most PCNs are benign or borderline tumors, such patients are eligible for minimally invasive pancreatic surgery.
Aim and Hypothesis: Here we design this prospective randomized clinical trial to compare robotic surgery to laparoscopic surgery for the treatment of PCN and verify the safety and feasibility of both two minimally invasive procedures. We conduct a single-center prospective randomized clinical trial to compare the outcomes of different minimally invasive techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older;
- •Diagnosed as PCN;
- •Patients with head or neck PCNs are eligible for minimal invasive PD, or patients with distal PCNs are eligible for minimal invasive DP.
排除标准
- •Not a PCN base on the sample's pathology;
- •Procedure change from MIDP/MIPD to others during the operation;
- •ASA more than 4;
- •Patients or families deny certain treatment.
结局指标
主要结局
Complication Rate
时间窗: up to 90 days
The rate of frequency of Clavein-Dindo Grade II-IV complication
次要结局
- Grade B and C pancreatic fistula(up to 90 days)
- VAS score(up to 90 days)
- 90-day death rate(up to 90 days)
- The rate of spleen-preservation(up to 90 days)
- Postoperative length of stay(during the treatment)
- QOL score(up to 90 days)
- Expense(during the treatment)