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

Phase 1

• Conditions: Patients undergoing total thyroidectomy with visualization of the parathyroid glands under infrared light after intraoperative intravenous injection of 5 mg of indocyanine green to predict the possible occurrence of postoperative hypocalcemia; MedDRA version: 20.1Level: LLTClassification code 10020949Term: HypocalcemiaSystem Organ Class: 100000004861; MedDRA version: 20.0Level: LLTClassification code 10043777Term: Thyroidectomy totalSystem Organ Class: 100000004865; MedDRA version: 21.0Level: PTClassification code 10080819Term: Post procedural hypoparathyroidismSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-003506-26-ES
• Lead Sponsor: Hospital Universitari Son Espases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-14
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified