Evaluation of the Interest of the Medical Device Called Fluobeam in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Mild Primary Hyperparathyroidism

Intervention / Treatment
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* Device: Use of the camera Fluobeam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult between 18 and 80 years old. Given signed written informed consent. Patient with moderated and sporadic primary hyperparathyroism (albumin-corrected serum calcium ≤2.85 mmol/l) requiring to be operated on. Patient affiliated to a social security system. Exclusion Criteria: Underage and adults under guardianship. Pregnant or breast feeding women. Patients with history of cervical radiotherapy or cervicotomy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: use of camera Fluobeam<br> | Device: Use of the camera Fluobeam<br>* Use of the camera Fluobeam to localize, visualize the parathyroid glands during a parathyroidectomy.<br>|
| No Intervention: Without use of the camera Fluobeam<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the time required for the parathyroidectomy with or without the utilization of the camera Fluobeam. |  | At Day 1(parathyroidectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. |  | 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. |  | 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) |  | 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. |  | At 6 months post parathyroïdectomy |