NCT04012476

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Son Espases · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 function and could be used as a diagnostic marker of postoperative hypoparathyroidism and hypocalcemia.

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, 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.

Conditions

• Hypocalcemia
• Total Thyroidectomy
• Hypoparathyroidism Postprocedural

Interventions

Type	Name	Description
DRUG	Indocyanine Green	Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-03-01
• Completion: 2020-10-01
• First posted: 2019-07-09
• Last updated: 2019-07-09

Locations

1 site across 1 country: Spain