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

Pancreatic Neuroendocrine Tumors Clinical Trial

Official title:

Use of Near Infrared Technology as a Guide in Laparoscopic Resection of Pancreatic Lesions: the COLPAN "Colour-and-resect" Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685553
• Other study ID #: COLPAN
• Status: Completed
• Phase: Phase 1
• First received: February 14, 2016
• Last updated: March 4, 2017
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Renal Cell
• Clear Cell Renal Carcinoma
• Kidney Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Pancreatic Neuroendocrine Tumors
• Solid Pseudopapillary Tumors of the Pancreas

Intervention

Device:
• NIR
Laparoscopic use of NIR

Locations

Country	Name	City	State
Italy	University of Verona Hospital	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Frangioni JV. In vivo near-infrared fluorescence imaging. Curr Opin Chem Biol. 2003 Oct;7(5):626-34. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypervascular pancreatic neoplasms detected intraoperatively by NIR		within the time of surgery