Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

Hypoparathyroidism Postprocedural Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509011
• Other study ID #: 2019-05948
• Status: Completed
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: July 31, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism
• Hypoparathyroidism Postprocedural

Intervention

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

Locations

Country	Name	City	State
Austria	Rudolfstiftung	Vienna
Norway	Haukeland University Hospital	Bergen
Poland	Jagiellonian University Medical College	Krakow
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Skåne University Hospital, Department of Surgery, Lund	Lund

Sponsors (5)

Lead Sponsor	Collaborator
Region Skane	Haukeland University Hospital, Hospital Rudolfstiftung, Jagiellonian University, Sahlgrenska University Hospital, Sweden

Countries where clinical trial is conducted

Austria,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative level of Parathyroid hormone (PTH)	Low plasma parathyroid hormone (PTH) (below the normal reference range)	First postoperative day
Secondary	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
Secondary	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
Secondary	Identification of parathyroid glands	Number of identified parathyroid glands	Intraoperatively
Secondary	Autotransplantation of parathyroid tissue	Number of autotransplanted parathyroid glands	Intraoperatively
Secondary	Excised parathyroid glands	Number of excised parathyroid glands found on the specimen at histopathology	One week
Secondary	Time for operation	Time for surgery (skin to skin) in minutes	Intraoperatively
Secondary	Hospital stay	Hospital stay in days	One week
Secondary	Re-hospitalization due to hypocalcaemia	Any subsequent hospitalization within 30 days for hypocalcaemia-related symptoms	One month