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

Not Applicable

Completed

• Conditions: Mild Primary Hyperparathyroidism
• Interventions: Device: Use of the camera "Fluobeam"

• Registration Number: NCT03643081
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Study Start: 2018-12-20
• Status Verified: 2024-01
• Primary Completion: 2024-01-08
• Study Completion: 2024-01-08
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
use of camera "Fluobeam"	Use of the camera "Fluobeam"	-

Primary Outcome Measures

Name	Time	Method
To compare the time required for the parathyroidectomy with or without the utilization of the camera "Fluobeam".	At Day 1(parathyroidectomy)

Secondary Outcome Measures

Name	Time	Method
To compare the results of the parathyroidectomy with or without the utilization of the camera "Fluobeam" in term of biological recovery.	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.
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France