Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:46 PM
Study NCT ID:
NCT05573828
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2022-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Study Overview
Official Title:
Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. GuiArte Multicentric Randomized Study.
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GuiArte
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: