Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery
- Conditions
- Hypoparathyroidism Postprocedural
- Interventions
- Device: Fluobeam® LX
- Registration Number
- NCT04509011
- Lead Sponsor
- Region Skane
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fluobeam® LX Fluobeam® LX Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands
- Primary Outcome Measures
Name Time Method Postoperative level of Parathyroid hormone (PTH) First postoperative day Low plasma parathyroid hormone (PTH) (below the normal reference range)
- Secondary Outcome Measures
Name Time Method Hospital stay One week Hospital stay in days
Excised parathyroid glands One week Number of excised parathyroid glands found on the specimen at histopathology
Time for operation Intraoperatively Time for surgery (skin to skin) in minutes
Identification of parathyroid glands Intraoperatively Number of identified parathyroid glands
Postoperative medication with oral calcium At discharge (up to 7 days), at 1 month and at 6 months Medication with oral calcium; calcium carbonate (A12AA04), and calcium lactate gluconate (A12AA06) Evaluated by standard questionaire in the database "Eurocrine" (yes/no)
Postoperative medication with Active vitamin D At discharge (up to 7 days), at 1 month and at 6 months 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)
Autotransplantation of parathyroid tissue Intraoperatively Number of autotransplanted parathyroid glands
Re-hospitalization due to hypocalcaemia One month Any subsequent hospitalization within 30 days for hypocalcaemia-related symptoms
Trial Locations
- Locations (5)
Skåne University Hospital, Department of Surgery, Lund
🇸🇪Lund, Sweden
Rudolfstiftung
🇦🇹Vienna, Austria
Jagiellonian University Medical College
🇵🇱Krakow, Poland
Haukeland University Hospital
🇳🇴Bergen, Norway
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden