Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

Study Overview
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Brief Summary
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The purpose of the investigation is to study if the use of Fluobeam®-LX to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low PTH in patients undergoing total thyroidectomy

Detailed Description
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Temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. The rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery. Patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active Vitamin D analogue therapy for more than 6 months, are at increased risk of renal insufficiency. They also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. Patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. Finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication. If, by using a technique for autofluorescence (Fluobeam® -LX), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease. Patients undergoing total thyroidectomy are randomized to the use of Fluobeam® -LX to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). Outcome is evaluated by parathyroid hormon (PTH) levels the first postoperative day and the need for medication with calcium and Vitamin D up to 6 months postoperatively.

Official Title
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Randomized Controlled Trial of Fluobeam® LX Compared With Clinical Assessment of Parathyroid Glands to Counteract Postoperatively Failing Parathyroid Function With Low Blood Calcium After Thyroid Surgery

Conditions
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Hypoparathyroidism Postprocedural

Intervention / Treatment
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* Device: Fluobeam® LX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis Exclusion Criteria: Previous thyroid surgery Previous parathyroid surgery Concurrent parathyroid surgery Renal insufficiency Pregnancy Breast feeding Allergy (contrast agent, iodine) Inability to understand study information Patient unable to participate in planned follow-up program

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluobeam® LX<br>Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands | Device: Fluobeam® LX<br>* Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.<br>|
| No Intervention: Control<br>In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative level of Parathyroid hormone (PTH) | Low plasma parathyroid hormone (PTH) (below the normal reference range) | First postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative medication with Active vitamin D | Medication with active Vitamin D; dihydrotachysterol (ATC A11CC02), alfacalcidol (ATC A11CC03), or calcitriol (ATC A11CC04) due to postoperative hypocalcaemia. Evaluated by standard questionaire in the database Eurocrine (yes/no) | At discharge (up to 7 days), at 1 month and at 6 months | 
| Postoperative medication with oral calcium | Medication with oral calcium; calcium carbonate (A12AA04), and calcium lactate gluconate (A12AA06) Evaluated by standard questionaire in the database Eurocrine (yes/no) | At discharge (up to 7 days), at 1 month and at 6 months | 
| Identification of parathyroid glands | Number of identified parathyroid glands | Intraoperatively | 
| Autotransplantation of parathyroid tissue | Number of autotransplanted parathyroid glands | Intraoperatively | 
| Excised parathyroid glands | Number of excised parathyroid glands found on the specimen at histopathology | One week | 
| Time for operation | Time for surgery (skin to skin) in minutes | Intraoperatively | 
| Hospital stay | Hospital stay in days | One week | 
| Re-hospitalization due to hypocalcaemia | Any subsequent hospitalization within 30 days for hypocalcaemia-related symptoms | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoparathyroidism, PTH, Hypocalcemia