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

Hospital Son Espases40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypocalcemia Total Thyroidectomy Hypoparathyroidism Postprocedural

Interventions

Indocyanine GreenDRUG

Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, Spain

RECRUITING

Outcomes

Primary Outcomes

Calcemia

Serum calcium level at 24 hours postoperatively

Time frame: Day 1 after surgery

Subjective parathyroid fluorescence

Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured on a subjective analogue scale (0: no fluorescence, 1: hypofluorescence or heterogeneous fluorescence, 2: homogeneous hyperfluorescence).

Time frame: Intraoperatively

Objective parathyroid fluorescence

Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc.

Time frame: Intraoperatively

Secondary Outcomes

Age

Patient's age

Time frame: Baseline

Sex

Patient's gender

Time frame: Baseline

Body mass index

Patient's BMI

Time frame: Baseline

Surgery date

Day when surgery takes place

Time frame: Baseline

Preoperative diagnosis

Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis)

Time frame: Baseline

Central Contacts

Jaime Bonnín Pascual, MD

CONTACT

871205959 jaime.bonnin@ssib.es

Data from ClinicalTrials.gov

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