CHU de Nantes
Nantes, 44093, France
NCT Number: NCT03643081
The aim of our study is to evaluate the value of the camera called "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nantes, 44093, France
Recently, it has been shown that parathyroid glands presented auto fluorescence, visible in the near infra-red light. Parathyroid glands emit at 822 nanometers when they are stimulated by a laser of 785 nanometers. Fluoptics Company (Fluoptics SAS, Grenoble, France) will provide a camera called "Fluobeam", facilitating the visualization of the parathyroid glands. The fluorescence intensity of the parathyroid glands is much more elevated than that of the surrounding tissues.
Preliminary work showed the interest of this technique. Benmiloud and collabortors have shown that the utilization of the "Fluobeam" enable to decrease the post total thyroidectomy hypocalcemia rate by a better visualization and preservation of the parathyroid glands.
The aim of this study is to evaluate the value of "Fluobeam" in the localization, visualization of the parathyroid glands for patients with mild primary hyperparathyroidism.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
Time frame: At Day 1(parathyroidectomy)
Time frame: At 6 months post parathyroïdectomy
To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery determined by normocalcemia (2,20 mmol/L < calcium < 2,60 mmol/L) at 6 months post surgery.
Time frame: At Day 1(parathyroidectomy)
Time frame: At 6 months post parathyroïdectomy
Time frame: At 6 months post parathyroïdectomy
Time frame: At 6 months post parathyroïdectomy
Nantes University Hospital
Other
Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism. A Randomized Controled Prospective Open -Labeled Monocentric Study.
Acronym: FLUO-PARA
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