The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice. PRIMARY OBJECTIVES: I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues. II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries. III. Assess the impact of PTeye on minimizing risk of post-surgical complications. Participants will be randomized to either the experimental or control arm. The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not. For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. Participants will be follow-ed up for up to 6 months after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
79
Intraoperative Tool
University of California, San Francisco
San Francisco, California, United States
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
Time frame: At the end of the parathyroidectomy, up to 5 hours
Number of Participants With Persistent Hyperparathyroidism (Immediate)
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop \> 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop \< 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
Time frame: 5-14 days after PTx procedure
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)
Elevated blood calcium levels (total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH \> 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
Time frame: 5-14 days after PTx procedure
Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level \> 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH \> 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
Time frame: Up to 6 months after PTx procedure
Number of Parathyroid Glands (PG) Identified
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent
The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration Taken to Identify First Parathyroid Gland
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
Time frame: During parathyroidectomy, up to 5 hours
Median Duration Taken to Identify Last Parathyroid Gland
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration of Parathyroidectomy (PTx) Procedure
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
Time frame: Up to 5 hours
Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize
Median time in minutes taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops \> 50% of its baseline value and/or PTH drops \< 65 pg/ml or 6.9 pmol/L
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Nights in the Hospital After Parathyroidectomy
Median number of nights spent in the hospital post-surgery is defined as having spent \<= 23 hours (0 nights) or \> 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.
Time frame: 0-72 hours after PTx procedure
Median Number of 'False Positive' Tissue Samples Excised by Surgeon
The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
Time frame: Up to 10 days after PTx procedure
Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions
Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.
Time frame: Up to 6 months after PTx procedure
Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)
Time frame: From 6 - 12 months after PTx procedure
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