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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| Jagiellonian University | OTHER |
| Sahlgrenska University Hospital | OTHER |
| Hospital Rudolfstiftung |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluobeam® LX | Experimental | Fluobeam® LX is used to detect autofluorescens and identify and evaluate parathyroid glands |
|
| Control | No Intervention | In the control group, the parathyroid glands are identified and evaluated by eye (ocular examination). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluobeam® LX | Device | Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative level of Parathyroid hormone (PTH) | Low plasma parathyroid hormone (PTH) (below the normal reference range) | First postoperative day |
| 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 |
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Inclusion Criteria:
Patients with thyroid disease planned for total thyroidectomy regardless of diagnosis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders OJ Bergenfelz, PhD | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rudolfstiftung | Vienna | 1030 | Austria | |||
| Haukeland University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37758507 | Derived | Bergenfelz A, Barczynski M, Heie A, Muth A, Passler C, Schneider M, Wierzbicka P, Konturek A, Brauckhoff K, Elf AK, Dahlberg J, Hermann M. Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial. Br J Surg. 2023 Nov 9;110(12):1824-1833. doi: 10.1093/bjs/znad278. |
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All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified
Starting 12 months after publication and for five years
Researchers within the medical community The principal investigator or the Central Contact Backup will review requests.
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| OTHER |
Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
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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.
| 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 |
| Bergen |
| 5021 |
| Norway |
| Jagiellonian University Medical College | Krakow | 31-008 | Poland |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Skåne University Hospital, Department of Surgery, Lund | Lund | 22185 | Sweden |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |