Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Study Overview
=================
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.

Official Title
-----------------
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Conditions
-----------------
Hypoparathyroidism, Thyroid Neoplasms, Thyroid Diseases, Endocrine System Diseases, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Head and Neck Neoplasms, Parathyroid Diseases

Intervention / Treatment
-----------------
* Device: PTeye


Participation Criteria
=================
Eligibility 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). 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTeye<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Duration measured in days | Within 1 month prior to surgery | 
| Duration of calcium and/or Vitamin D supplementation | Duration measured in days | Up to 3 months after surgery | 
| Number of postsurgical complications | Medical record review | Up to 3 months after surgery | 
| Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery | Medical record review | up to 30 days | 
| Number of auto-transplanted parathyroid glands | Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | Immediate. During total thyroidectomy procedure | 
| Number of nights spent in the hospital after total thyroidectomy | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. | 0 - 72 hours after total thyroidectomy | 
| Number of inadvertently resected parathyroid glands | Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. | Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report) | 
| Overall number of parathyroid glands identified. | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) | Immediate (During total thyroidectomy procedure) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative Hypoparathyroidism, Total Thyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Postoperative Hypocalcemia