Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of in
| Condition(s) | Iatrogenic Hypocalcemia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism. The goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arterio |
| Who can participate | Inclusion Criteria: * Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology. * The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document. Exclusion Criteria: * Previous surgical intervention on the thyroid or parathyroid gland. * Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act. * Patients with contraindications for the administration of ICG. * Current drug use or alcohol abuse that could interfere with compliance with the study requirements. * Participation in any other drug trials in the month prior to randomization. |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Hospital Universitari de Bellvitge |
| Locations | L'Hospitalet de Llobregat, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain |
| Start date | 2022-10-11 |
| NCT ID | NCT05573828 |
| Official listing | https://clinicaltrials.gov/study/NCT05573828 |