Hypercalcemia, Parathyroid Adenoma, Parathyroid Cancer, Parathyroid Neoplasms, Primary Hyperparathyroidism
Conditions
Keywords
Parathyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy
Brief summary
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.
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.
Interventions
DEVICEPTeye
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.
OTHERStandard of Care
The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Sponsors
National Cancer Institute (NCI)
Vanderbilt University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Only participants will be masked to the intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Parathyroid Glands Identified | Measured within the procedure, generally not more than 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | 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. |
| Appropriate Intraoperative Parathyroid Hormone Drop | baseline to 10 minutes | \>50% drop from baseline at 10 minutes post-resection |
| Duration of Surgery | Measured within the procedure, generally not more than 2 hours | Surgery duration in minutes |
| Number of Nights Spent in the Hospital After Parathyroidectomy | 0-72 hours after PTx procedure. | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. |
| Number of Frozen Sections | Immediate | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PTeye The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery.
PTeye: 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. | 81 |
| Standard of Care The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. | 79 |
| Total | 160 |
Baseline characteristics
| Characteristic | PTeye | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 15.2 | 61.1 years STANDARD_DEVIATION 15.5 | 61.2 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants | 78 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Final Diagnosis Other | 0 Participants | 2 Participants | 2 Participants |
| Final Diagnosis Primary sporadic hyperparathyroidism | 78 Participants | 77 Participants | 155 Participants |
| Final Diagnosis Recurrent/persistent hyperparathyroidism | 3 Participants | 0 Participants | 3 Participants |
| Preoperative calcium (pg/dL) | 11.5 pg/dL STANDARD_DEVIATION 4.4 | 10.8 pg/dL STANDARD_DEVIATION 0.6 | 11.2 pg/dL STANDARD_DEVIATION 3.2 |
| Preoperative PTH (pg/mL) | 125.9 pg/mL STANDARD_DEVIATION 78 | 124.1 pg/mL STANDARD_DEVIATION 66.4 | 125 pg/mL STANDARD_DEVIATION 72.3 |
| Preoperative vitamin D (mcg) | 37.7 mcg STANDARD_DEVIATION 16 | 35.8 mcg STANDARD_DEVIATION 15.2 | 36.8 mcg STANDARD_DEVIATION 15.6 |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 76 Participants | 69 Participants | 145 Participants |
| Region of Enrollment United States | 81 participants | 79 participants | 160 participants |
| Sex: Female, Male Female | 59 Participants | 65 Participants | 124 Participants |
| Sex: Female, Male Male | 22 Participants | 14 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 79 |
| other Total, other adverse events | 0 / 81 | 0 / 79 |
| serious Total, serious adverse events | 0 / 81 | 0 / 79 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTeye | Average Number of Parathyroid Glands Identified | 2.7 parathyroid glands per patient |
| Standard of Care | Average Number of Parathyroid Glands Identified | 2.6 parathyroid glands per patient |
p-value: 0.6t-test, 2 sided
Secondary
Appropriate Intraoperative Parathyroid Hormone Drop
\>50% drop from baseline at 10 minutes post-resection
Time frame: baseline to 10 minutes
Population: Some participants' data was not collected by the surgeons during the baseline-to-10-minute time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Appropriate Intraoperative Parathyroid Hormone Drop | Yes | 45 Participants |
| PTeye | Appropriate Intraoperative Parathyroid Hormone Drop | No | 35 Participants |
| Standard of Care | Appropriate Intraoperative Parathyroid Hormone Drop | No | 19 Participants |
| Standard of Care | Appropriate Intraoperative Parathyroid Hormone Drop | Yes | 56 Participants |
p-value: 0.02Chi-squared
Secondary
Duration of Surgery
Surgery duration in minutes
Time frame: Measured within the procedure, generally not more than 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTeye | Duration of Surgery | 92.3 minutes | Standard Deviation 40.2 |
| Standard of Care | Duration of Surgery | 88.8 minutes | Standard Deviation 42.3 |
p-value: 0.6t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Number of Frozen Sections | 0 frozen sections taken | 49 Participants |
| PTeye | Number of Frozen Sections | 1 or more frozen sections taken | 32 Participants |
| Standard of Care | Number of Frozen Sections | 0 frozen sections taken | 47 Participants |
| Standard of Care | Number of Frozen Sections | 1 or more frozen sections taken | 32 Participants |
p-value: 0.6Chi-squared
Secondary
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Number of Nights Spent in the Hospital After Parathyroidectomy | 0 nights | 77 Participants |
| PTeye | Number of Nights Spent in the Hospital After Parathyroidectomy | 1 night | 4 Participants |
| Standard of Care | Number of Nights Spent in the Hospital After Parathyroidectomy | 0 nights | 76 Participants |
| Standard of Care | Number of Nights Spent in the Hospital After Parathyroidectomy | 1 night | 3 Participants |
Secondary
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
Population: Not all participants returned for this lab assessment during the 5-14 day data collection period. As such, no data for these participants was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTeye | Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | 23 pg/mL | Standard Deviation 26.9 |
| Standard of Care | Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery | 25.3 pg/mL | Standard Deviation 23.4 |
p-value: 0.65t-test, 2 sided