Actively Recruiting
PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.
Led by Marcin Barczynski · Updated on 2025-09-02
154
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this randomized clinical trial is to learn if there are any added benefits of using near-infrared autofluorescence (NIRAF) probe-based imaging system (the PTeye) for intraoperative identification of parathyroid glands (PGs) during thyroid surgery in comparison to visual identification of PGs by the surgeon's naked eyes without PTeye. The main questions it aims to answer are: * Is number of PGs identified intraoperatively and preserved in situ larger in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with undetectable or low parathormone serum level on postoperative day 1 fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients requiring substitution therapy with calcium and vitamin D analogue fewer after thyroid operations with PTeye versus surgeon's naked eyes without PTeye in a short-term (\< 6 weeks) and/or in a long-term (at 6 months) follow-up? * Is numer of inadvertenly removed and reimplanted PGs fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of frozen sections fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of PGs identified by pathologist in the surgical specimen fewer in in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? * Is number of patients with symptomatic hypoparathyroidism within 30 days of the operation fewer in thyroid operations with PTeye versus surgeon's naked eyes without PTeye? The hypothesis explored in this study is that use of PTeye in comparison to the surgeon's naked eyes may be beneficial for intraoperative identification and preservation of PGs in thyroid surgery leading to reduced risk of postoperative hypoparathyroidism. A prospective, randomized study with 2 arms: use of PTeye vs. visual identification of PGs without PTeye (n=77 patients, each). The primary outcome measure is number of intraoperatively identified PGs with use of PTeye vs without it.
CONDITIONS
Official Title
PTeye vs Surgeons Eyes in Intraoperative Identification and Functional Preservation of Parathyroid Glands During Thyroid Surgery: A Parallel Randomized Controlled Clinical Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with thyroid disease qualified for first-time total thyroidectomy.
You will not qualify if you...
- History of thyroid or parathyroid surgery
- Planned simultaneous thyroid and parathyroid surgery
- Renal failure
- Pregnancy
- Lactation
- Allergy to contrast agents and/or iodine
- Inability to understand the study protocol
- Inability to participate in planned postoperative follow-up
- Age below 18 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Endocrine Surgery, Faculty of Medicine, Jagiellonian University Medical College
Krakow, Małopolska, Poland, 31-501
Actively Recruiting
Research Team
M
Marcin Barczyński, MD, PhD
CONTACT
A
Aleksander Konturek, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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