Suspended

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

What is being tested

Indocyanine Green

Drug

Who is being recruted

Calcium Metabolism Disorders+2

+ Hypocalcemia

+ Metabolic Diseases

Over 18 Years

+12 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 4

Interventional

Study Start: November 2016

See protocol details

Summary

Principal SponsorHospital Son Espases

Study ContactJaime Bonnín Pascual, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2016

Actual date on which the first participant was enrolled.

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

NCT04012476

Principal SponsorHospital Son Espases

Study ContactJaime Bonnín Pascual, MD

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Calcium Metabolism DisordersHypocalcemiaMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Criteria

6 inclusion criteria required to participate

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.

Show More Criteria

6 exclusion criteria prevent from participating

Age <18 years

Hepatic or renal insufficiency

Hypersensitivity to iodine or to indocyanine green.

Pregnancy or lactation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Universitari Son Espases

Palma de Mallorca, SpainOpen Hospital Universitari Son Espases in Google Maps

SuspendedOne Study Center