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Clinical Trials/NCT02125929
NCT02125929
Completed
N/A

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

Peking Union Medical College Hospital1 site in 1 country156 target enrollmentApril 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic Neuroendocrine Tumors
Sponsor
Peking Union Medical College Hospital
Enrollment
156
Locations
1
Primary Endpoint
Pancreatic fistula rate
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pancreatic fistula rate

Time Frame: up to 30 days

Secondary Outcomes

  • Mortality rate(up to 30 days)

Study Sites (1)

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