Fluorescence Angiography: Planning and Monitoring of Perforator Flaps

NCT01681797 | Terminated DMC

• 1 other identifier: DCIC/11/13
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.

Conditions

Reconstructive Surgery

Keywords

fluorescent angiography; reconstructive surgery; perforator flap

Outcome Measures

Primary Outcomes (1)

• Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection

  For each flap, the position of the flap determined by fluorescent angiography will be compared with the anatomic position (actual) determined on the relevant flap after dissection (gold standard).

  During the first fluorescent angiography

Secondary Outcomes (3)

• Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)

  During the first fluorescent angiography

• Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography

  Just after micro-vascular anastomoses

• Postoperative monitoring of flap perfusion using fluorescence angiography

  Every six hours for four days after surgery

Study Arms (1)

add-on fluorescence angiography

EXPERIMENTAL

The surgeon will prescribe the usual morphological assessment of the proposed flap: * CT angiography for an anterolateral thigh flap or an epigastric inferior flap * A Doppler ultrasonography for a fibula flap. In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days.

Device: Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)

Interventions

Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company) DEVICE

Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)

Also known as: The device used in this study is the Fluobeam™ imaging system developed by the company Fluoptics., the technique requires the injection of a tracer Infracyanine® (SERB pharmaceutical company)

add-on fluorescence angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• perforator flap reconstruction whatever the indication (cancer, trauma, malformations). The main targets are the fibula flaps, anterolateral thigh flaps and inferior epigastric flaps
• consenting patient

You may not qualify if:

• known indocyanine green allergy
• pregnant woman, parturient woman or nursing woman

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital of Grenoble

Grenoble, Isere, 38043, France

Location

Related Publications (1)

• Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.

  PMID: 20210462 BACKGROUND

MeSH Terms

Interventions

Fluorescein Angiography

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Study Officials

• Georges BETTEGA, MD, PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 10, 2012
• Study Start: August 1, 2012
• Primary Completion: October 10, 2015
• Study Completion: October 10, 2015
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

FR (1)