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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypocalcemia, Total Thyroidectomy, Hypoparathyroidism Postprocedural

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single group: patients undergoing total thyroidectomy with intraoperative infusion of intravenous indocyanine green A prospective unicentric and open clinical trial in which the fluorescence intensity of the parathyroid glands after indocyanine administration will be compared between two groups of patients: those with post-thyroidectomy hypocalcemia and patients who do not present it.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG<br>Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green | Drug: Indocyanine Green<br>* Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcemia | Serum calcium level at 24 hours postoperatively | 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). | Intraoperatively | 
| Objective parathyroid fluorescence | Fluorescence intensity of the parathyroid glands after administration of indocyanine green (ICG), measured by specific computer software developed ad hoc. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Patient's age | Baseline | 
| Sex | Patient's gender | Baseline | 
| Body mass index | Patient's BMI | Baseline | 
| Surgery date | Day when surgery takes place | Baseline | 
| Preoperative diagnosis | Thyroid pathology indicating total thyroidectomy (thyroid carcinoma, atypical of uncertain significance, goiter or lymphocytic thyroiditis) | Baseline | 
| Vitamin D | Preoperative vitamin D level | Preoperative blood test | 
| PTH preop | Preoperative PTH level | Immediately before surgery | 
| PTH 10 min | PTH levels 10 minutes post-thyroidectomy | 10 minutes post-thyroidectomy | 
| Surgery | Scope of surgery: total thyroidectomy (TT), TT with central neck dissection, or TT with functional lateral neck dissection | Inmediately after surgery | 
| Time | Duration of surgery | Inmediately after surgery | 
| Parathyroid glands | Number of parathyroid glands located during surgery, | During surgery | 
| Parathyroid gland location | Location of the parathyroid glands (superior right, inf-right, sup-left, inf-left). | During surgery | 
| Pathologic result | Outcome of thyroid pathology (papillary carcinoma, nodular hyperplasia or lymphocytic thyroiditis) | during the first month after surgery | 
| Thyroid weight | Thyroid weight | during the first month after surgery | 
| PG in piece | Presence of parathyroid glands in the surgical piece and number | during the first month after surgery | 
| Stay | Number of days of postoperative hospital stay until the day of hospital discharge, measured as full days of 24 hours | During the first month after surgery | 
| Drain | Presence and number of surgical drainages | Inmediately after surgery | 
| PTH day 1 | PTH levels in the postoperative follow-up, | Day 1 after surgery | 
| Complications | Emergence of postoperative complications. | During the first month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypocalcemia post-thyroidectomy, Indocyanine green, Fluorescence guided surgery, Parathyroid fluorescence