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Near Infrared Technology and Laparoscopic Resection of Pancreatic Lesions: the COLPAN Project

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ClinicalTrials.gov Identifier: NCT02685553
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Salvatore Paiella, MD, Universita di Verona

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.

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumors Clear Cell Renal Carcinoma Solid Pseudopapillary Tumors of the Pancreas Device: NIR Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project
Actual Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: 1
Use of NIR
Device: NIR
Laparoscopic use of NIR




Primary Outcome Measures :
  1. Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR [ Time Frame: within the time of surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02685553


Locations
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Italy
University of Verona Hospital
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona

Publications:
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Responsible Party: Salvatore Paiella, MD, MD, PhD student, Universita di Verona
ClinicalTrials.gov Identifier: NCT02685553     History of Changes
Other Study ID Numbers: COLPAN
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Renal Cell
Kidney Neoplasms
Pancreatic Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases