NCT02685553CompletedPhase 1
Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project
Universita di Verona1 site in 1 country10 target enrollmentStarted: February 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
Use of NIR
Intervention: NIR (Device)
Outcomes
Primary Outcomes
Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR
Time Frame: within the time of surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Salvatore Paiella, MD
MD, PhD student
Universita di Verona
Study Sites (1)
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