Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms

Study Overview
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Brief Summary
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To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors

Detailed Description
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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.

Official Title
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Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors

Conditions
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Pancreatic Neuroendocrine Tumors

Intervention / Treatment
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* Procedure: Robotic surgery
* Procedure: Laparoscopic surgery
* Procedure: Open surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic arm<br>robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 | Procedure: Robotic surgery<br>* Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors<br>|
| Experimental: Laparoscopic surgery<br>laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 | Procedure: Laparoscopic surgery<br>* Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors<br>|
| Experimental: Open surgery<br>Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100 | Procedure: Open surgery<br>* Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic fistula rate |  | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | up to 30 days |