Clinical trial NCT05022667: Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Official title: Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Neoplasms
Thyroid Diseases
Hypoparathyroidism
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Parathyroid Diseases
Keywords: Total Thyroidectomy
Intraoperative Parathyroid Identification
Near Infrared Autofluorescence
Postoperative Hypocalcemia
Postoperative Hypoparathyroidism
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2021-08-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Blood calcium levels
timeFrame: Before surgery (baseline)
measure: Blood calcium levels
timeFrame: Within 24 hours after surgery
measure: Blood parathyroid hormone (PTH) levels
timeFrame: Within 24 hours after surgery
measure: Blood parathyroid hormone (PTH) levels
timeFrame: 5-14 days after surgery
measure: Blood parathyroid hormone (PTH) levels
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Duration in minutes of surgery
timeFrame: Collected immediately following surgery
measure: Number of frozen section analysis performed(By case)
timeFrame: Collected immediately following surgery
measure: Percent of frozen sections confirmed as parathyroid tissue
timeFrame: Frozen results collected immediately after surgery.
measure: Permanent histology reports of all excised tissues
timeFrame: Permanent histology collected after report generated by pathologist (5-7 days)
measure: History of calcium and/or Vitamin D supplementation
timeFrame: Within 1 month prior to surgery (including daily dose)
measure: History of calcium and/or Vitamin D supplementation
timeFrame: up to 3 months after surgery (including daily dose)
measure: Duration of calcium and/or Vitamin D supplementation
timeFrame: Within 1 month prior to surgery
measure: Duration of calcium and/or Vitamin D supplementation
timeFrame: Up to 3 months after surgery
measure: Number of postsurgical complications
timeFrame: Up to 3 months after surgery
measure: Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery
timeFrame: up to 30 days
measure: Number of auto-transplanted parathyroid glands
timeFrame: Immediate. During total thyroidectomy procedure
measure: Number of nights spent in the hospital after total thyroidectomy
timeFrame: 0 - 72 hours after total thyroidectomy
measure: Number of inadvertently resected parathyroid glands
timeFrame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)
measure: Overall number of parathyroid glands identified.
timeFrame: Immediate (During total thyroidectomy procedure)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul Gauger, MD
role: PRINCIPAL_INVESTIGATOR
References: