Status:
UNKNOWN
Determination of Parathyroid Function by Fluorescence With Indocyanine Green (ICG) After Total Thyroidectomy
Lead Sponsor:
Hospital Son Espases
Collaborating Sponsors:
Universitat de les Illes Balears
Conditions:
Hypocalcemia
Total Thyroidectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The intensity of parathyroid fluorescence that occurs after intravenous injection of indocyanine green during the performance of a total thyroidectomy correlates with postoperative parathyroid functio...
Detailed 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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04012476
Start Date
November 1 2016
End Date
October 1 2020
Last Update
July 9 2019
Active Locations (1)
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1
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain, 07120