Clinical trial NCT04509011: Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoparathyroidism Postprocedural
Keywords: Hypoparathyroidism
PTH
Hypocalcemia
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Jagiellonian University
name: Sahlgrenska University Hospital
name: Hospital Rudolfstiftung
First posted: 2020-08-11
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (intraoperative use of Fluobeam®-LX during thyroid surgery) Control group (clinical assessment and identification of parathyroid glands during thyroid surgery)
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Postoperative level of Parathyroid hormone (PTH)
timeFrame: First postoperative day
Secondary outcomes:
measure: Postoperative medication with Active vitamin D
timeFrame: At discharge (up to 7 days), at 1 month and at 6 months
measure: Postoperative medication with oral calcium
timeFrame: At discharge (up to 7 days), at 1 month and at 6 months
measure: Identification of parathyroid glands
timeFrame: Intraoperatively
measure: Autotransplantation of parathyroid tissue
timeFrame: Intraoperatively
measure: Excised parathyroid glands
timeFrame: One week
measure: Time for operation
timeFrame: Intraoperatively
measure: Hospital stay
timeFrame: One week
measure: Re-hospitalization due to hypocalcaemia
timeFrame: One month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudolfstiftung
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Krakow
country: Poland
facility: Jagiellonian University Medical College
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital, Department of Surgery, Lund
Study officials:
affiliation: Skane University Hospital
name: Anders OJ Bergenfelz, PhD
role: PRINCIPAL_INVESTIGATOR
References: