NIRAF-camera Versus Conventional Surgery in Preoperative Imaging Negative Primary Hyperparathyroidism
Outcomes of Parathyroidectomy Using NIRAF-camera Versus Conventional Surgery in Patients With Preoperative Imaging Negative Primary Hyperparathyroidism: A Randomized Controlled Trial
Primary hyperparathyroidism (PHPT) is a prevalent endocrine disorder, with an estimated prevalence of 0.86% in the United States. The only definitive treatment for PHPT is parathyroidectomy. Preoperative localization of abnormal parathyroid glands (PGs) is typically achieved using ultrasound imaging and 99mTc-sestamibi scans, which aid in surgical planning and reducing intraoperative gland detection time and increasing the likelihood of successful gland identification. However, reported cure rates can be as low as 79.5%, because of the challenges in identifying PGs intraoperatively.
Near-infrared autofluorescence (NIRAF) imaging has recently emerged as a promising adjunctive tool for intraoperative PG identification, particularly in thyroidectomy and parathyroidectomy procedures. It has been FDA-approved as an adjunctive tool for parathyroid identification. NIRAF imaging distinguishes normal PGs, which typically appear bright and homogeneous, from abnormal PGs, which are dim and heterogeneous (Figure). Previous studies have demonstrated that NIRAF-camera technology enhances PG detection during thyroidectomy, leading to improved surgical outcomes and reduced postoperative hypoparathyroidism rates. However, limited research exists regarding its application in parathyroidectomy procedures, with only a few studies suggesting its potential benefits, such as a reduction in the need for frozen sections. At the Cleveland Clinic, parathyroidectomy procedures are done with or without the use of this NIRAF technology, based on surgeon preference and both approaches are considered as part of standard of care.
To date, no study has specifically investigated the use of NIRAF technology in PHPT patients in terms of time to PG detection. Given the challenges associated with localizing abnormal PGs in such cases, further research is warranted to explore the potential of NIRAF imaging in improving surgical outcomes. This is a study, randomizing patients to parathyroidectomy with or without (conventional surgery) NIRAF imaging. Surgeons in the control group (conventional) will not be using the NIRAF camera in the procedures unless he/she/they feel a need to use it based on intraoperative findings and surgeon decision. The conventional surgery patients in whom the surgeon decides to use the camera will continue to be analyzed in the original group, with the intention to treat principle, but these cross overs will be recorded and reported as a data field.
Primary Study Aim: To assess whether NIRAF-Camera helps to decrease the gland detection time in PHPT cases.
Secondary Study Aim: To evaluate the impact of NIRAF-Camera on post-operative cure rates and number of frozen sections done in PHPT cases.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- Chaise Brewer
- Phone Number: 216-672-2131
- Email: brewerc3@ccf.org
-
Principal Investigator:
- Eren Berber
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with primary hyperparathyroidism
- Undergoing bilateral neck exploration
- Will under go only parathyroidectomy surgery
Exclusion Criteria:
- Diagnosed with secondary or tertiary hyperparathyroidism
- Undergoing focal PG exploration
- Will undergo concomitant surgery (total thyroidectomy, thyroid lobectomy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conventional Parathyroidectomy (without NIRAF-camera)
|
|
|
Active Comparator: Parathyroidectomy with NIRAF-camera
|
Near-infrared autofluorescence (NIRAF) camera as an adjunctive tool used for intraoperative identification of abnormal parathyroid glands.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gland detection time
Time Frame: intraoperative
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cure rates
Time Frame: 2 weeks and 6 months post-op
|
2 weeks and 6 months post-op
|
|
Number of Frozen Sections
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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