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

Not Applicable

Recruiting

• Conditions: Hypoparathyroidism; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Parathyroid Diseases
• Interventions: Device: PTeye

• Registration Number: NCT05022667
• Lead Sponsor: University of Michigan

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-26
• Study Start: 2021-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTeye	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.

Primary Outcome Measures

Name	Time	Method
Blood parathyroid hormone (PTH) levels	6 months after surgery
Blood calcium levels	Within 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Number of frozen section analysis performed(By case)	Collected immediately following surgery
Permanent histology reports of all excised tissues	Permanent histology collected after report generated by pathologist (5-7 days)
Percent of frozen sections confirmed as parathyroid tissue	Frozen results collected immediately after surgery.
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.
Duration of calcium and/or Vitamin D supplementation	Up to 3 months after surgery	Duration measured in days
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.
Duration in minutes of surgery	Collected immediately following surgery
Number of postsurgical complications	Up to 3 months after surgery	Medical record review
History of calcium and/or Vitamin D supplementation	up to 3 months after surgery (including daily dose)
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.
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)

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States