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

University of Michigan114 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

114

Conditions

Thyroid Neoplasms Thyroid Diseases Hypoparathyroidism Endocrine System Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient

Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

Time frame: Immediate (During total thyroidectomy procedure)

Secondary Outcomes

Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery

Blood parathyroid hormone (PTH) levels at 5-14 days post-op

Time frame: 5-14 days after surgery

Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery

Blood parathyroid hormone (PTH) levels at 24-48 hours after surgery

Time frame: Within 24-48 hours after surgery

Blood Calcium Levels 24-48 Hours After Surgery

Blood calcium levels 24-48 hours after surgery

Time frame: Within 24-48 hours after surgery

Duration in Minutes of Surgery

Duration of surgery (minutes)

Time frame: Collected immediately following surgery

Number of Frozen Section Analysis Performed.

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.

Time frame: Collected immediately following surgery

Number of Auto-transplanted Parathyroid Glands

Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.

Time frame: Immediate. During total thyroidectomy procedure

Number of Nights Spent in the Hospital After Total Thyroidectomy

Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

Time frame: 0 - 4 nights after total thyroidectomy

Number of Inadvertently Resected Parathyroid Glands

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.

Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)