Near Infrared Technology And Laparoscopic Resection Of Pancreatic Lesions: The COLPAN Project

Study Overview

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

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.

N/A

Pancreatic Neuroendocrine Tumors
Clear Cell Renal Carcinoma
Solid Pseudopapillary Tumors of the Pancreas

DEVICE: NIR

COLPAN

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-04
First Submitted that Met QC Criteria 2016-02-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-07
First Posted (ACTUAL) 2016-02-18	Results First Posted N/A	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 Use of NIR	DEVICE: NIR Laparoscopic use of NIR

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

Use of NIR

DEVICE: NIR

Laparoscopic use of NIR

Primary Outcome Measures	Measure Description	Time Frame
Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR		within the time of surgery

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

age between 18 and 80
diagnosis of hypervascular pancreatic neoplasms to be treated with laparoscopic surgery

allergy to indocyanine green or other vital stains, indium, shellfish
chronic kidney insufficiency
chronic hepatopathy
hyperthyroidism, thyroid adenomas

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.
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.

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