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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
132
Use of the camera "Fluobeam" to localize, visualize the parathyroid glands during a parathyroidectomy.
CHU de Nantes
Nantes, France
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
Time frame: At Day 1(parathyroidectomy)
To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.
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 6 months post parathyroïdectomy
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.
Time frame: At Day 1(parathyroidectomy)
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis.
Time frame: At 6 months post parathyroïdectomy
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of parathyroid morbidity (hypocalcemia with calcémia below 2 mmol/L)
Time frame: At 6 months post parathyroïdectomy
To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of cost-utility analysis according to the societal perspective and over a 6 months' time horizon of the surgery.
Time frame: At 6 months post parathyroïdectomy
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