Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
Not Applicable
Completed
- Conditions
- Pancreatic Neuroendocrine Tumors
- Registration Number
- NCT02125929
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
- 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
Exclusion Criteria
- Severe cardio/pulmonary complications
- Other pancreatic diseases, including pancreatitis and pancreatic cancer
- Multiple pancreatic neuroendocrine tumors
- Distant metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Pancreatic fistula rate up to 30 days
- Secondary Outcome Measures
Name Time Method Mortality rate up to 30 days
Trial Locations
- Locations (1)
Department of General Surgery, Peking Union medical school hospital
🇨🇳Beijing, Beijing, China
Department of General Surgery, Peking Union medical school hospital🇨🇳Beijing, Beijing, China