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Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
Sponsor: Onze Lieve Vrouw Hospital
Summary
* Hypoparathyroidism (and the resulting hypocalcemia) remains the most common morbidity after a total thyroidectomy. * The identification and preservation of parathyroid glands during neck surgery has always been challenging but is crucial to avoid postoperative hypocalcemia. * Recently, the specific autofluorescent characteristics of endogenous fluorophores in the parathyroid tissue have been used to detect and confirm parathyroid glands during thyroid surgery. * Injecting indocyanine green and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands. * This randomized clinical trial aims to investigate whether using autofluorescence and indocyanine green during thyroid surgery can predict or prevent postoperative hypocalcemia.
Official title: The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2021-11-01
Completion Date
2025-05-31
Last Updated
2024-04-05
Healthy Volunteers
No
Interventions
Autofluorescent detection + Injection of indocyanine green
All four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue. The timepoints of AF will be: * 1 = after lateral dissection side 1 (side 1) * 2= after lateral dissection side 2 (side 2) The timepoints of ICG injection will be: * 1 = after the first thyroid lobectomy (side 1) * 2 = after the second thyroid lobectomy (side 2) Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016): * 1 = black = not viable/vascularized * 2 = grey = moderately viably/ moderately vascularized * 3 = white = viable/well-vascularized
Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Gold standard of visual identification and evaluation of viability of the parathyroid glands.
Locations (1)
Onze Lieve Vrouw Hospital
Aalst, Belgium