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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

* 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.

Who May Be Eligible (Plain English)

Who May Qualify: - All adult patients undergoing a total thyroidectomy without previous neck surgery. Who Should NOT Join This Trial: - Children and teenagers (\<18 years old) - Patients refusing participation or unable/unwilling to sign the willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * All adult patients undergoing a total thyroidectomy without previous neck surgery. Exclusion Criteria: * 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

Treatments Being Tested

DRUG

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

PROCEDURE

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