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

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ClinicalTrials.gov Identifier: NCT02125929
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors Procedure: Robotic surgery Procedure: Laparoscopic surgery Procedure: Open surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


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




Primary Outcome Measures :
  1. Pancreatic fistula rate [ Time Frame: up to 30 days ]

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: up to 30 days ]

Other Outcome Measures:
  1. Intra-operative bleeding volume [ Time Frame: intra operative ]
  2. Operation Time [ Time Frame: Intra operative ]
  3. Conversion rate to open surgery [ Time Frame: Intra operative ]
    Only applied to the robotic surgery arm and laparoscopic arm

  4. Quality of life and pain scores [ Time Frame: up to 30 days ]
  5. Delayed gastric emptying rate [ Time Frame: up to 30 days ]
  6. Intra-abdominal bleeding rate [ Time Frame: up to 30 days ]
  7. Postoperative infection rate [ Time Frame: up to 30 days ]
  8. Hospital stay time [ Time Frame: up to 30 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125929


Locations
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China, Beijing
Department of General Surgery, Peking Union medical school hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Yupei Zhao, MD Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02125929     History of Changes
Other Study ID Numbers: PUMCHGS2013
ENRLO ( Other Identifier: Peking Union Medical College Hospital )
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases