Pancreatic Neuroendocrine Tumors
Conditions
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.
Interventions
PROCEDURERobotic surgery
Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
PROCEDURELaparoscopic surgery
Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
PROCEDUREOpen surgery
Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pancreatic fistula rate | up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Mortality rate | up to 30 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate to open surgery | Intra operative | Only applied to the robotic surgery arm and laparoscopic arm |
| Quality of life and pain scores | up to 30 days | — |
| Delayed gastric emptying rate | up to 30 days | — |
| Intra-operative bleeding volume | intra operative | — |
| Postoperative infection rate | up to 30 days | — |
| Hospital stay time | up to 30 days | — |
| Intra-abdominal bleeding rate | up to 30 days | — |
| Operation Time | Intra operative | — |
Countries
China
Outcome results
None listed