Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

University of Michigan160 enrolled

Overview

This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

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

160

Conditions

Parathyroid Adenoma Parathyroid Neoplasms Parathyroid Cancer Hypercalcemia

Interventions

PTeyeDEVICE

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.

Standard of CareOTHER

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary hyperparathyroidism who will be undergoing parathyroid surgery * Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: * Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.) * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy * Patients with secondary or tertiary hyperparathyroidism

Outcomes

Primary Outcomes

Average Number of Parathyroid Glands Identified

Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.

Time frame: Measured within the procedure, generally not more than 2 hours

Secondary Outcomes

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

Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.

Time frame: 5-14 days after surgery

Appropriate Intraoperative Parathyroid Hormone Drop

\>50% drop from baseline at 10 minutes post-resection

Time frame: baseline to 10 minutes

Duration of Surgery

Surgery duration in minutes

Time frame: Measured within the procedure, generally not more than 2 hours

Number of Nights Spent in the Hospital After Parathyroidectomy

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

Time frame: 0-72 hours after PTx procedure.

Number of Frozen Sections

Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.

Time frame: Immediate