Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

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

Haukeland University Hospital, Jagiellonian University, Sahlgrenska University Hospital, Sweden, Hospital Rudolfstiftung

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

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.

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

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.

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

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

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)

Medication with oral calcium; calcium carbonate (A12AA04), and calcium lactate gluconate (A12AA06) Evaluated by standard questionaire in the database "Eurocrine" (yes/no)

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

All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified

Researchers within the medical community The principal investigator or the Central Contact Backup will review requests.