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

August 4, 2015 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Department of General Surgery, Peking Union medical school hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pancreatic fistula rate
Time Frame: up to 30 days
up to 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: up to 30 days
up to 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative bleeding volume
Time Frame: intra operative
intra operative
Operation Time
Time Frame: Intra operative
Intra operative
Conversion rate to open surgery
Time Frame: Intra operative
Only applied to the robotic surgery arm and laparoscopic arm
Intra operative
Quality of life and pain scores
Time Frame: up to 30 days
up to 30 days
Delayed gastric emptying rate
Time Frame: up to 30 days
up to 30 days
Intra-abdominal bleeding rate
Time Frame: up to 30 days
up to 30 days
Postoperative infection rate
Time Frame: up to 30 days
up to 30 days
Hospital stay time
Time Frame: up to 30 days
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 26, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCHGS2013
  • ENRLO (Other Identifier: Peking Union Medical College Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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