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Clinical Trials in Spain / NCT05573828
Recruiting Not applicable

Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function

NCT05573828 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Universitari de Bellvitge
Phase
Not applicable
Started
2022-10-11
Last updated
2025-03-19

Condition(s) studied

Iatrogenic Hypocalcemia

Investigational drug(s) / intervention(s)

ICG angiography to show vascular map of parathyroid glands

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Rate of participants with postoperative permanent hypoparathyroidism — 1 year
    Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.

Trial sites (2)

FacilityCityRegionStatus
Hospital UIniversitari de Bellvitge L'Hospitalet de Llobregat Barcelona Recruiting
Pablo Moreno Llorente L'Hospitalet de Llobregat Barcelona Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05573828 on ClinicalTrials.gov ↗ ← All trials in Spain