Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy

Hospital Son Espases

Status and phase: Unknown; Phase 4

Conditions: Hypoparathyroidism Postprocedural; Total Thyroidectomy; Hypocalcemia

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT04012476

ICG-Parathyroid

Details and patient eligibility

About

The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

Full description

The main objective of the study is to compare the intensity of parathyroid fluorescence among patients who present post-thyroidectomy hypocalcemia with that of patients who do not have it. Therefore, the following points will be studied:

• To study the correlation between parathyroid vascularization (intraoperative fluorescence intensity) and postoperative glandular function (serum calcium and parathormone levels).
• To compare the surgeon's subjective assessment of parathyroid fluorescence in the groups of patients with and without postoperative hypocalcemia.
• To compare the objective assessment of parathyroid fluorescence, by using specific computer software developed ad hoc, in the groups of patients with and without postoperative hypocalcemia.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are going to undergo total thyroidectomy, with or without cervical lymph node dissection.
• Visualization of 2 or more parathyroid glands during the surgical act.
• Normal renal and hepatic functions.
• Absence of a history of hypersensitivity reactions to iodine or indocyanine green.
• Able to understand the nature and protocol of the study and its procedures
• Willingness to participate with the subsequent signing of informed consent.

Exclusion criteria

• Age <18 years
• Hepatic or renal insufficiency
• Hypersensitivity to iodine or to indocyanine green.
• Pregnancy or lactation
• Inability to understand the nature and procedures of the study.
• Patients with known preoperative hyperparathyroidism.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ICG

Experimental group

Description:

Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green

Treatment:

Drug: Indocyanine Green