NCT05573828

Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function

Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 394 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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 arteriography than without. Patients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy. Researchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.

Detailed description

To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention. It will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values \< 1.8 mmol/L.

Conditions

• Iatrogenic Hypocalcemia

Interventions

Type	Name	Description
PROCEDURE	ICG angiography to show vascular map of parathyroid glands	Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio

Timeline

• Start date: 2022-10-11
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-10-10
• Last updated: 2025-03-19

Locations

2 sites across 1 country: Spain