Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project
Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 14, 2016
CompletedFirst Posted
Study publicly available on registry
February 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 7, 2017
March 1, 2017
8 months
February 14, 2016
March 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
within the time of surgery
Study Arms (1)
1
EXPERIMENTALUse of NIR
Interventions
Eligibility Criteria
You may qualify if:
- age between 18 and 80
- diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery
You may not qualify if:
- allergy to indocyanine green or other vital stains, indium, shellfish
- chronic kidney insufficiency
- chronic hepatopathy
- hyperthyroidism, thyroid adenomas
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Verona Hospital
Verona, Verona, 37134, Italy
Related Publications (4)
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.
PMID: 14580568BACKGROUNDVerbeek 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.
PMID: 22790312BACKGROUNDvan 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.
PMID: 22905287BACKGROUNDWiner 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.
PMID: 20033320BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
February 14, 2016
First Posted
February 18, 2016
Study Start
February 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 7, 2017
Record last verified: 2017-03