Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Not Applicable

Completed

• Conditions: Hypoparathyroidism; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Parathyroid Diseases

• Registration Number: NCT05022667
• Lead Sponsor: University of Michigan

Brief Summary

This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Detailed Description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-26
• Study Start: 2021-12-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Disposition First Submitted: 2025-05-30
• Results First Submitted: 2025-07-06
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Results First Posted: 2025-08-08
• Disposition First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
• Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

Exclusion Criteria

• Pregnant women
• Patients with concurrent parathyroid and thyroid disease
• Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
• Patients undergoing thyroid lobectomy or partial thyroidectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient	Immediate (During total thyroidectomy procedure)	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

Secondary Outcome Measures

Name	Time	Method
Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery	5-14 days after surgery	Blood parathyroid hormone (PTH) levels at 5-14 days post-op
Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery	Within 24-48 hours after surgery	Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery
Blood Calcium Levels 24-48 Hours After Surgery	Within 24-48 hours after surgery	Blood calcium levels 24-48 hours after surgery
Duration in Minutes of Surgery	Collected immediately following surgery	Duration of surgery (minutes)
Number of Frozen Section Analysis Performed.	Collected immediately following surgery	Number of frozen section analysis performed. Samples of a suspected piece of parathyroid tissue were removed and analyzed to confirm whether they were actually parathyroid tissue. Results reflect the participants who were determined to have had a frozen section conducted.
Number of Auto-transplanted Parathyroid Glands	Immediate. During total thyroidectomy procedure	Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Number of Nights Spent in the Hospital After Total Thyroidectomy	0 - 4 nights after total thyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of Inadvertently Resected Parathyroid Glands	Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)	Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. Results reflect the participants who had an inadvertently resected parathyroid gland.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States