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NCT Number: NCT05573828

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 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.

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Key information

Conditions

Iatrogenic Hypocalcemia Calcium Metabolism Disorders Hypocalcemia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital UIniversitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICG angiography to show vascular map of parathyroid glands

Procedure

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

Primary outcomes

  1. Rate of participants with postoperative permanent hypoparathyroidism

    Time frame: 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 outcomes

  1. Rate of participants with severe permanent hypocalcemia

    Time frame: 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.

  2. Number of parathyroid glands identified and preserved

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pablo Moreno

CONTACT

[email protected]

661214772

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Acronym: GuiArte

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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