Clinical trial NCT03643081: Evaluation of the Interest of the Medical Device Called "Fluobeam" in the Localization, Visualization of the Parathyroid Glands for Patients With Mild Primary Hyperparathyroidism
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Primary Hyperparathyroidism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".
timeFrame: At Day 1(parathyroidectomy)
Secondary outcomes:
measure: To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.
timeFrame: At 6 months post parathyroïdectomy
measure: To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of number of visualized parathyroid glands.
timeFrame: At Day 1(parathyroidectomy)
measure: To compare the results of the surgery with or without the utilization of the "Fluobeam" in term of post-surgery laryngeal paralysis.
timeFrame: At 6 months post parathyroïdectomy
measure: 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)
timeFrame: At 6 months post parathyroïdectomy
measure: 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.
timeFrame: At 6 months post parathyroïdectomy
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Eric MIRALLIE, Pr
role: PRINCIPAL_INVESTIGATOR
References: