Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2023-07-31

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

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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.

Conditions

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Hypoparathyroidism Postprocedural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The participant is not informed of the assigned group, whereas the the care giver (surgeon) is informed due to the use (or not) of the Fluobeam®-LX.

Randomization is performed 1: 1 in blocks of 10 via the Eurocrine quality register platform.

Study Groups

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Fluobeam® LX

Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands

Group Type EXPERIMENTAL

Fluobeam® LX

Intervention Type DEVICE

Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.

Control

In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fluobeam® LX

Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No