Autofluorescence vs Clinical Assessment of Parathyroid Glands During Thyroid Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Hypoparathyroidism Postprocedural
• Intervention / Treatment: Device: Fluobeam® LX

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 Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1030
    • Rudolfstiftung
• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital
• Poland
  • Krakow, Poland, 31-008
    • Jagiellonian University Medical College
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital
  • Lund, Sweden, 22185
    • Skåne University Hospital, Department of Surgery, Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative level of Parathyroid hormone (PTH)	Low plasma parathyroid hormone (PTH) (below the normal reference range)	First postoperative day

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Jagiellonian University; Sahlgrenska University Hospital, Sweden; Haukeland University Hospital; Hospital Rudolfstiftung
• Investigators: Principal Investigator: Anders OJ Bergenfelz, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Hypocalcemia; Hypoparathyroidism; PTH
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hypoparathyroidism
• Other Study ID Numbers: 2019-05948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in a publication. Individuals are de-identified
• IPD Sharing Time Frame: Starting 12 months after publication and for five years
• IPD Sharing Access Criteria: Researchers within the medical community The principal investigator or the Central Contact Backup will review requests.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No