Endocrine Gland Neoplasms, Endocrine System Diseases, Head and Neck Neoplasms, Hypoparathyroidism, Neoplasms, Neoplasms by Site, Parathyroid Diseases, Thyroid Diseases, Thyroid Neoplasms
Conditions
Keywords
Total Thyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Postoperative Hypocalcemia, Postoperative Hypoparathyroidism
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.
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, as per device functionality requirements.
Sponsors
Vanderbilt University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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. |
| 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. |
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 total thyroidectomy procedure.
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, as per device functionality requirements. | 57 |
| Standard of Care The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. | 57 |
| Total | 114 |
Baseline characteristics
| Characteristic | PTeye | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 16.9 | 51.9 years STANDARD_DEVIATION 16.4 | 52.6 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 109 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Final Diagnosis Goiters and nodular diseases | 13 Participants | 19 Participants | 6 Participants |
| Final Diagnosis Grave's disease | 18 Participants | 33 Participants | 15 Participants |
| Final Diagnosis Thyroid cancer | 26 Participants | 62 Participants | 36 Participants |
| Preoperative calcium (pg/dL) | 9.4 (pg/dL) STANDARD_DEVIATION 0.5 | 9.5 (pg/dL) STANDARD_DEVIATION 0.5 | 9.5 (pg/dL) STANDARD_DEVIATION 0.4 |
| Preoperative PTH (pg/mL) | 48.2 (pg/mL) STANDARD_DEVIATION 22.4 | 64.6 (pg/mL) STANDARD_DEVIATION 27.9 | 78.3 (pg/mL) STANDARD_DEVIATION 25 |
| Preoperative vitamin D (mcg) | 33 mcg STANDARD_DEVIATION 13.6 | 30.9 mcg STANDARD_DEVIATION 12 | 29.3 mcg STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Asian | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 47 Participants | 96 Participants | 49 Participants |
| Region of Enrollment United States | 57 Participants | 114 Participants | 57 Participants |
| Sex: Female, Male Female | 44 Participants | 87 Participants | 43 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 0 / 57 | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PTeye | The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient | 3.1 parathyroid glands per patient |
| Standard of Care | The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient | 2.9 parathyroid glands per patient |
p-value: 0.3t-test, 2 sided
Secondary
Blood Calcium Levels 24-48 Hours After Surgery
Blood calcium levels 24-48 hours after surgery
Time frame: Within 24-48 hours after surgery
Population: Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTeye | Blood Calcium Levels 24-48 Hours After Surgery | 9.4 pg/dL | Standard Deviation 0.5 |
| Standard of Care | Blood Calcium Levels 24-48 Hours After Surgery | 9.3 pg/dL | Standard Deviation 0.5 |
p-value: 0.3t-test, 2 sided
Secondary
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
Population: Not all participants returned for this lab assessment during the 24-48 hour data collection period. As such, no data for these participants was collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTeye | Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery | 20.7 pg/mL | Standard Deviation 11.6 |
| Standard of Care | Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery | 24.3 pg/mL | Standard Deviation 16.6 |
p-value: 0.2t-test, 2 sided
Secondary
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
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 | Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery | 35.6 pg/mL | Standard Deviation 25.3 |
| Standard of Care | Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery | 41 pg/mL | Standard Deviation 34.7 |
p-value: 0.5t-test, 2 sided
Secondary
Duration in Minutes of Surgery
Duration of surgery (minutes)
Time frame: Collected immediately following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PTeye | Duration in Minutes of Surgery | 126.2 minutes | Standard Deviation 39.6 |
| Standard of Care | Duration in Minutes of Surgery | 120.3 minutes | Standard Deviation 34.7 |
p-value: 0.4t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Number of Auto-transplanted Parathyroid Glands | 0 | 41 Participants |
| PTeye | Number of Auto-transplanted Parathyroid Glands | 1 | 16 Participants |
| PTeye | Number of Auto-transplanted Parathyroid Glands | 2 or more | 0 Participants |
| Standard of Care | Number of Auto-transplanted Parathyroid Glands | 0 | 46 Participants |
| Standard of Care | Number of Auto-transplanted Parathyroid Glands | 1 | 10 Participants |
| Standard of Care | Number of Auto-transplanted Parathyroid Glands | 2 or more | 1 Participants |
p-value: 0.3Chi-squared
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Number of Frozen Section Analysis Performed. | 0 | 55 Participants |
| PTeye | Number of Frozen Section Analysis Performed. | 1 or more | 2 Participants |
| Standard of Care | Number of Frozen Section Analysis Performed. | 0 | 55 Participants |
| Standard of Care | Number of Frozen Section Analysis Performed. | 1 or more | 2 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PTeye | Number of Inadvertently Resected Parathyroid Glands | 5 Participants |
| Standard of Care | Number of Inadvertently Resected Parathyroid Glands | 5 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PTeye | Number of Nights Spent in the Hospital After Total Thyroidectomy | 0 nights | 0 Participants |
| PTeye | Number of Nights Spent in the Hospital After Total Thyroidectomy | 1 night | 57 Participants |
| PTeye | Number of Nights Spent in the Hospital After Total Thyroidectomy | > 1 night | 0 Participants |
| Standard of Care | Number of Nights Spent in the Hospital After Total Thyroidectomy | 0 nights | 0 Participants |
| Standard of Care | Number of Nights Spent in the Hospital After Total Thyroidectomy | 1 night | 57 Participants |
| Standard of Care | Number of Nights Spent in the Hospital After Total Thyroidectomy | > 1 night | 0 Participants |