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

Not Applicable

Completed

• Conditions: Pancreatic Neuroendocrine Tumors
• Interventions: Procedure: Laparoscopic surgery; Procedure: Robotic surgery; Procedure: Open surgery

• 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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-26
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06

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

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgery	Laparoscopic surgery	laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
robotic arm	Robotic surgery	robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
Open surgery	Open surgery	Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100

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