Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy
The Use of Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Total Thyroidectomy: A Randomized Clinical Trial
Onze Lieve Vrouw Hospital
300 participants
Nov 1, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- All adult patients undergoing a total thyroidectomy without previous neck surgery.
Exclusion Criteria6
- Children and teenagers (\<18 years old)
- Patients refusing participation or unable/unwilling to sign the informed consent
- Patients with a completion thyroidectomy
- Patients with planned central and lateral neck lymph node dissections (thyroid cancer)
- Patients with previous neck surgery
- Patients with a known allergy/hypersensitivity to indocyanine green
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05117853