Postoperative Hypoparathyroidism, Thyroid Cancer, Thyroid Disease, Thyroid Neoplasms
Conditions
Brief summary
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Detailed description
Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (\< 6 months) in 5 - 35% of cases or permanent hypocalcemia (\> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach as utilized in 'PTeye', which is medical device that was recently FDA-cleared. However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.
Interventions
Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid. Other Name: PTeye Device
Sponsors
National Cancer Institute (NCI)
Vanderbilt University
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Only participants will be masked to the intervention.
Intervention model description
NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group. Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology). The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (nm) laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid). (ii) All patients undergoing completion thyroidectomy.
Exclusion criteria
(i) Patients with concurrent parathyroid disease. (ii) Patients with incidental enlarged parathyroid discovered during TTx. (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Transient Hypoparathyroidism. | 24-48 hours post-op | The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL. |
| Patients With Hypoparathyroidism at Last Follow-up | 2 days to 1 year after surgery | The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Auto-transplanted Parathyroid Glands | Immediate (during total thyroidectomy, up to 3 hours) | Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. |
| Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | 0-72 hours after total thyroidectomy | Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure. |
| Overall Average Number of Parathyroid Glands Identified With High Confidence. | Immediate (during total thyroidectomy, up to 3 hours) | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) |
| Number of Doctor Visits/Emergency Department Visits or Hospital Admissions | Up to 6 months after total thyroidectomy | Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms. |
| Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery | Up to 6 months after total thyroidectomy | Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation. |
| Number of Participants With Inadvertently Resected Parathyroid Glands | Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report) | Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. |
| Number of Participants With Frozen Sections Sent for Analysis. | Immediate (during total thyroidectomy, up to 3 hours) | Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIRAF Detection Technology (+) Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
NIRAF Detection Technology: Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
Other Name: PTeye Device | 39 |
| NIRAF Detection Technology (-) Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). | 41 |
| Total | 80 |
Baseline characteristics
| Characteristic | NIRAF Detection Technology (+) | NIRAF Detection Technology (-) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 11 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 30 Participants | 61 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 32 Participants | 64 Participants |
| Region of Enrollment United States | 39 participants | 41 participants | 80 participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 56 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 0 / 39 | 0 / 41 |
| serious Total, serious adverse events | 0 / 39 | 0 / 41 |
Outcome results
Primary
Patients With Hypoparathyroidism at Last Follow-up
The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.
Time frame: 2 days to 1 year after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIRAF Detection Technology (+) | Patients With Hypoparathyroidism at Last Follow-up | 1 Participants |
| NIRAF Detection Technology (-) | Patients With Hypoparathyroidism at Last Follow-up | 1 Participants |
Primary
Subjects With Transient Hypoparathyroidism.
The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL.
Time frame: 24-48 hours post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIRAF Detection Technology (+) | Subjects With Transient Hypoparathyroidism. | 10 Participants |
| NIRAF Detection Technology (-) | Subjects With Transient Hypoparathyroidism. | 14 Participants |
Secondary
Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.
Time frame: Up to 6 months after total thyroidectomy
Population: We would not be able to provide precise data regarding duration and total daily dosage. Following surgery, those at risk for hypocalcemia are prescribed calcium standing dose and patients are also counseled to take additional calcium supplements. It is not possible to calculate an exact dose. Patients often take calcium supplements. Therefore, the additional calcium and the exact duration of when they stopped additional calcium is challenging for patients and was not collected in the trial.
Secondary
Number of Doctor Visits/Emergency Department Visits or Hospital Admissions
Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.
Time frame: Up to 6 months after total thyroidectomy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIRAF Detection Technology (+) | Number of Doctor Visits/Emergency Department Visits or Hospital Admissions | 0 Number of events |
| NIRAF Detection Technology (-) | Number of Doctor Visits/Emergency Department Visits or Hospital Admissions | 0 Number of events |
Secondary
Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy
Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure.
Time frame: 0-72 hours after total thyroidectomy
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NIRAF Detection Technology (+) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | 0 nights | 0 Participants |
| NIRAF Detection Technology (+) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | 1 night | 39 Participants |
| NIRAF Detection Technology (+) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | more than one night | 0 Participants |
| NIRAF Detection Technology (-) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | 0 nights | 1 Participants |
| NIRAF Detection Technology (-) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | 1 night | 38 Participants |
| NIRAF Detection Technology (-) | Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy | more than one night | 2 Participants |
Secondary
Number of Participants With Auto-transplanted Parathyroid Glands
Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NIRAF Detection Technology (+) | Number of Participants With Auto-transplanted Parathyroid Glands | o auto-transplanted parathyroid glands | 31 Participants |
| NIRAF Detection Technology (+) | Number of Participants With Auto-transplanted Parathyroid Glands | 1 auto-transplanted parathyroid glands | 7 Participants |
| NIRAF Detection Technology (+) | Number of Participants With Auto-transplanted Parathyroid Glands | greater than or equal to 2 auto-transplanted parathyroid glands | 1 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Auto-transplanted Parathyroid Glands | o auto-transplanted parathyroid glands | 31 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Auto-transplanted Parathyroid Glands | 1 auto-transplanted parathyroid glands | 8 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Auto-transplanted Parathyroid Glands | greater than or equal to 2 auto-transplanted parathyroid glands | 2 Participants |
Secondary
Number of Participants With Frozen Sections Sent for Analysis.
Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NIRAF Detection Technology (+) | Number of Participants With Frozen Sections Sent for Analysis. | 0 frozen sections | 38 Participants |
| NIRAF Detection Technology (+) | Number of Participants With Frozen Sections Sent for Analysis. | greater than or equal to 1 frozen sections | 1 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Frozen Sections Sent for Analysis. | 0 frozen sections | 30 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Frozen Sections Sent for Analysis. | greater than or equal to 1 frozen sections | 11 Participants |
Secondary
Number of Participants With Inadvertently Resected Parathyroid Glands
Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NIRAF Detection Technology (+) | Number of Participants With Inadvertently Resected Parathyroid Glands | 9 Participants |
| NIRAF Detection Technology (-) | Number of Participants With Inadvertently Resected Parathyroid Glands | 8 Participants |
Secondary
Overall Average Number of Parathyroid Glands Identified With High Confidence.
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, up to 3 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NIRAF Detection Technology (+) | Overall Average Number of Parathyroid Glands Identified With High Confidence. | 3.4 Number of parathyroid glands |
| NIRAF Detection Technology (-) | Overall Average Number of Parathyroid Glands Identified With High Confidence. | 2.9 Number of parathyroid glands |