Back to resultsNear Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
Primary Purpose
Pancreatic Neuroendocrine Tumors, Clear Cell Renal Carcinoma, Solid Pseudopapillary Tumors of the Pancreas
Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
NIR
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 80
- diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery
Exclusion Criteria:
- allergy to indocyanine green or other vital stains, indium, shellfish
- chronic kidney insufficiency
- chronic hepatopathy
- hyperthyroidism, thyroid adenomas
Sites / Locations
- University of Verona Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Use of NIR
Outcomes
Primary Outcome Measures
Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02685553
Brief Title
Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
Official Title
Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the use of Near-Infrared Technology can guide the laparoscopic resection of hypervascular neoplasms of the pancreas.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neuroendocrine Tumors, Clear Cell Renal Carcinoma, Solid Pseudopapillary Tumors of the Pancreas
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Use of NIR
Intervention Type
Device
Intervention Name(s)
NIR
Intervention Description
Laparoscopic use of NIR
Primary Outcome Measure Information:
Title
Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
Time Frame
within the time of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age between 18 and 80
diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery
Exclusion Criteria:
allergy to indocyanine green or other vital stains, indium, shellfish
chronic kidney insufficiency
chronic hepatopathy
hyperthyroidism, thyroid adenomas
Facility Information:
Facility Name
University of Verona Hospital
City
Verona
ZIP/Postal Code
37134
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
14580568
Citation
Frangioni JV. In vivo near-infrared fluorescence imaging. Curr Opin Chem Biol. 2003 Oct;7(5):626-34. doi: 10.1016/j.cbpa.2003.08.007.
Results Reference
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PubMed Identifier
22790312
Citation
Verbeek FP, van der Vorst JR, Schaafsma BE, Hutteman M, Bonsing BA, van Leeuwen FW, Frangioni JV, van de Velde CJ, Swijnenburg RJ, Vahrmeijer AL. Image-guided hepatopancreatobiliary surgery using near-infrared fluorescent light. J Hepatobiliary Pancreat Sci. 2012 Nov;19(6):626-37. doi: 10.1007/s00534-012-0534-6.
Results Reference
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PubMed Identifier
22905287
Citation
van der Vorst JR, Vahrmeijer AL, Hutteman M, Bosse T, Smit VT, van de Velde CJ, Frangioni JV, Bonsing BA. Near-infrared fluorescence imaging of a solitary fibrous tumor of the pancreas using methylene blue. World J Gastrointest Surg. 2012 Jul 27;4(7):180-4. doi: 10.4240/wjgs.v4.i7.180.
Results Reference
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PubMed Identifier
20033320
Citation
Winer JH, Choi HS, Gibbs-Strauss SL, Ashitate Y, Colson YL, Frangioni JV. Intraoperative localization of insulinoma and normal pancreas using invisible near-infrared fluorescent light. Ann Surg Oncol. 2010 Apr;17(4):1094-100. doi: 10.1245/s10434-009-0868-8. Epub 2009 Dec 22.
Results Reference
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Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
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