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2014-04
2014-12
2014-12
156
NCT02125929
Peking Union Medical College Hospital
Peking Union Medical College Hospital
INTERVENTIONAL
Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-04-26 | N/A | 2015-08-04 |
2014-04-28 | N/A | 2015-08-06 |
2014-04-29 | N/A | 2015-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Factorial
Masking:
None
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
|
| EXPERIMENTAL: Laparoscopic surgery laparoscopic surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 50 | PROCEDURE: Laparoscopic surgery
|
| EXPERIMENTAL: Open surgery Open surgery for enucleation benign Pancreatic Neuroendocrine Tumors Case number = 100 | PROCEDURE: Open surgery
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pancreatic fistula rate | up to 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Mortality rate | up to 30 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
