Fluorescence Angiography: Planning and Monitoring of Perforator Flaps

NCT ID: NCT01681797

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-10-10

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.

Detailed Description

Reconstructive surgery is intended to replace amputated anatomical regions by autologous tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal sequelae. Among the flaps available, perforator flaps have the advantage of being highly plastic, large and can be taken from accessory vessels the loss of wich does not compromise the vitality of the sampling site. However their more variable anatomy requires irradiating preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is not always performed by the surgeon himself and does not distinguish between muscle perforator and skin perforator.

Fluorescence angiography is a superficial exploration technique of vascularization. After intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides useful surface angiographic imaging in real-time. It can also help in monitoring intraoperative and postoperative quality of vascular anastomoses. Although fluorescence angiography has numerous applications (ophthalmology, neurosurgery, liver transplantation...), its usefulness in surgical flaps is only supported by a few publications. None really validate its clinical value by comparing it to reference investigations (CT angiography or doppler ultrasonography).

40 candidate for reconstructive surgery will be included in this study. The day before surgery, in addition to the usual technique used to locate perforator flaps, the patient will receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of interest of the flap will be explored with the Fluobeam™ camera.

Two hours after the surgery, during the usual clinical monitoring of the vitality of the flap, a new injection of Infracyanine® will test perfusion of the flap by measuring fluorescence intensity of the target area. These measurement will then be repeated every 6 hours for 4 days.

Conditions

Reconstructive Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

add-on fluorescence angiography

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

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

Intervention Type: DEVICE

Other Intervention Names

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)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georges BETTEGA, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital of Grenoble

Grenoble, Isere, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20210462 (View on PubMed)

Other Identifiers

DCIC/11/13

Identifier Type: -

Identifier Source: org_study_id