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

Primary Purpose

Pancreatic Neuroendocrine Tumors

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robotic surgery
Laparoscopic surgery
Open surgery
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neuroendocrine Tumors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General Surgery, Peking Union medical school hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

robotic arm

Laparoscopic surgery

Open surgery

Arm Description

robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50

laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50

Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100

Outcomes

Primary Outcome Measures

Pancreatic fistula rate

Secondary Outcome Measures

Mortality rate

Full Information

First Posted
April 26, 2014
Last Updated
August 4, 2015
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02125929
Brief Title
Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
Official Title
Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neuroendocrine Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
robotic arm
Arm Type
Experimental
Arm Description
robotic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
Arm Title
Laparoscopic surgery
Arm Type
Experimental
Arm Description
laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50
Arm Title
Open surgery
Arm Type
Experimental
Arm Description
Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100
Intervention Type
Procedure
Intervention Name(s)
Robotic surgery
Intervention Description
Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic surgery
Intervention Description
Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Intervention Type
Procedure
Intervention Name(s)
Open surgery
Intervention Description
Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors
Primary Outcome Measure Information:
Title
Pancreatic fistula rate
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Mortality rate
Time Frame
up to 30 days
Other Pre-specified Outcome Measures:
Title
Intra-operative bleeding volume
Time Frame
intra operative
Title
Operation Time
Time Frame
Intra operative
Title
Conversion rate to open surgery
Description
Only applied to the robotic surgery arm and laparoscopic arm
Time Frame
Intra operative
Title
Quality of life and pain scores
Time Frame
up to 30 days
Title
Delayed gastric emptying rate
Time Frame
up to 30 days
Title
Intra-abdominal bleeding rate
Time Frame
up to 30 days
Title
Postoperative infection rate
Time Frame
up to 30 days
Title
Hospital stay time
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yupei Zhao, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Surgery, Peking Union medical school hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27480993
Citation
Tian F, Hong XF, Wu WM, Han XL, Wang MY, Cong L, Dai MH, Liao Q, Zhang TP, Zhao YP. Propensity score-matched analysis of robotic versus open surgical enucleation for small pancreatic neuroendocrine tumours. Br J Surg. 2016 Sep;103(10):1358-64. doi: 10.1002/bjs.10220. Epub 2016 Aug 2.
Results Reference
derived

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

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