Study of Usefulness of Fluorescence in Thiroid Surgery

Thyroid Surgery Clinical Trial

— ECA_SPAFLUO  

Official title:

A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011369
• Other study ID #: IMIB-SPAFLUO
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: Beatriz Febrero, MD
• Phone: 968 36 95 00
• Email: beatriz.febrero[@]um.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In thyroid surgery, the identification and preservation of the parathyroid glands and their vascularization is essential to avoid postoperative hypoparathyroidism. In this sense, fluorescence technology with autofluorescence (AF) can help us avoid this post-surgical complication. This study aims to determine the advantages offered by fluorescence in thyroid surgery, taking into account various clinical variables. For this, a randomized study is proposed in patients undergoing thyroid surgery with and without cervical fluorescence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total thyroidectomy with/without lymph node dissection
• Signature of informed consent

Exclusion Criteria:

• Patients under 18 years of age
• Hemithyroidectomy
• Reintervention of thyroid surgery

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Surgery

Intervention

Procedure:
• Fluorescence in thyroid surgery
Fluorescence in thyroid surgery

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type of surgery performed	total thyroidectomy/hemithyroidectomy; lymphadenectomy	Up to 12 months.
Primary	Number of parathyroid glands identified before the use of AF (Autofluorescence)	Gland count	Up to 12 months.
Primary	Number and location of parathyroid glands identified with the use of FA (Autofluorescence)	Gland count	Up to 12 months.
Primary	Quantification of each parathyroid gland with AF(Autofluorescence)	(two determinations in the same parathyroid gland, in total, eight determinations of the parathyroid glands parathyroid, and three determinations in the thyroid gland, the last being in a nodule if it'd exist	Up to 12 months.
Primary	Number of glands accidentally removed.	Gland count	Up to 12 months.
Primary	Number of autotransplanted glands.	Gland count	Up to 12 months.
Primary	Surgical time.	Hours of surgery	Up to 12 months.
Primary	Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)	Number of surgeries using autofluorescence	Up to 12 months.
Primary	Concentration of PTH and calcium corrected by albumin and/or ionic	Value in analytics	4, 24 Hours
Primary	Concentration of PTH and calcium corrected by albumin and/or ionic	Value in analytics	6,12 Months