- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681797
Fluorescence Angiography: Planning and Monitoring of Perforator Flaps (AFLU)
Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Isere
-
Grenoble, Isere, France, 38043
- University hospital of Grenoble
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: add-on fluorescence angiography
The surgeon will prescribe the usual morphological assessment of the proposed 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. |
Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection
Time Frame: During the first fluorescent angiography
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: During the first fluorescent angiography
|
For each flap, the position of the flap determined by fluorescent angiography will be compared with the position 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
Time Frame: Just after micro-vascular anastomoses
|
Intraoperative monitoring of vascular flow through the micro-anastomoses will be determined by:
|
Just after micro-vascular anastomoses
|
Postoperative monitoring of flap perfusion using fluorescence angiography
Time Frame: Every six hours for four days after surgery
|
This is to test the hypothesis that the dynamics of the fluorescence intensity in the area of interest is a prognostic factor for postoperative complications.
|
Every six hours for four days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Georges BETTEGA, MD, PHD, University Hospital, Grenoble
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DCIC/11/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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