Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function

Not Applicable

Recruiting

• Conditions: Iatrogenic Hypocalcemia
• Interventions: Procedure: ICG angiography to show vascular map of parathyroid glands

• Registration Number: NCT05573828
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

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.

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2022-10-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 394

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Angiography group	ICG angiography to show vascular map of parathyroid glands	Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Number of parathyroid glands identified and preserved	1 year	Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy between the two groups.
Rate of participants with severe permanent hypocalcemia	1 year	Comparison of the occurrence of severe permanent hypocalcemia after total thyroidectomy between the two groups. Severe hypocalcemia is considered when vitamin D is added to the treatment with calcium. Permanent hypocalcemia is defined when it lasts more than 12 months.

Trial Locations

Locations (2)

Hospital UIniversitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain

Pablo Moreno Llorente; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain