Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fluobeam® LX Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands |
Device: Fluobeam® LX
Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.
|
| No Intervention: Control In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination). |
Outcome Measures
Primary Outcome Measures
- Postoperative level of Parathyroid hormone (PTH) [First postoperative day]
Low plasma parathyroid hormone (PTH) (below the normal reference range)
Secondary Outcome Measures
- 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)
- 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)
- Identification of parathyroid glands [Intraoperatively]
Number of identified parathyroid glands
- Autotransplantation of parathyroid tissue [Intraoperatively]
Number of autotransplanted parathyroid glands
- 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
- Hospital stay [One week]
Hospital stay in days
- Re-hospitalization due to hypocalcaemia [One month]
Any subsequent hospitalization within 30 days for hypocalcaemia-related symptoms
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rudolfstiftung | Vienna | Austria | 1030 | |
| 2 | Haukeland University Hospital | Bergen | Norway | 5021 | |
| 3 | Jagiellonian University Medical College | Krakow | Poland | 31-008 | |
| 4 | Sahlgrenska University Hospital | Gothenburg | Sweden | 41345 | |
| 5 | Skåne University Hospital, Department of Surgery, Lund | Lund | Sweden | 22185 |
Sponsors and Collaborators
- Region Skane
- Haukeland University Hospital
- Jagiellonian University
- Sahlgrenska University Hospital, Sweden
- Hospital Rudolfstiftung
Investigators
- Principal Investigator: Anders OJ Bergenfelz, PhD, Skane University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-05948