Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
|
| No Intervention: 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. |
Outcome Measures
Primary Outcome Measures
- Blood calcium levels [Before surgery (baseline)]
- Blood calcium levels [Within 24 hours after surgery]
- Blood parathyroid hormone (PTH) levels [Within 24 hours after surgery]
- Blood parathyroid hormone (PTH) levels [5-14 days after surgery]
- Blood parathyroid hormone (PTH) levels [6 months after surgery]
Secondary Outcome Measures
- Duration in minutes of surgery [Collected immediately following surgery]
- Number of frozen section analysis performed(By case) [Collected immediately following surgery]
- Percent of frozen sections confirmed as parathyroid tissue [Frozen results collected immediately after surgery.]
- Permanent histology reports of all excised tissues [Permanent histology collected after report generated by pathologist (5-7 days)]
- History of calcium and/or Vitamin D supplementation [Within 1 month prior to surgery (including daily dose)]
- History of calcium and/or Vitamin D supplementation [up to 3 months after surgery (including daily dose)]
- Duration of calcium and/or Vitamin D supplementation [Within 1 month prior to surgery]
Duration measured in days
- Duration of calcium and/or Vitamin D supplementation [Up to 3 months after surgery]
Duration measured in days
- Number of postsurgical complications [Up to 3 months after surgery]
Medical record review
- Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery [up to 30 days]
Medical record review
- 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 - 72 hours 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.
- Overall number of parathyroid glands identified. [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)
Eligibility Criteria
Criteria
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).
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Cancer Institute (NCI)
- Vanderbilt University
Investigators
- Principal Investigator: Paul Gauger, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00194322
- R01CA212147