ECA_SPAFLUO: STUDY OF USEFULNESS OF FLUORESCENCE IN THYROID SURGERY

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06011369
• Collaborator: (none)
• Enrollment: 260
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 16.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Surgery	Procedure: Fluorescence in thyroid surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: PROSPECTIVE, CONTROLLED, RANDOMIZEDPROSPECTIVE, CONTROLLED, RANDOMIZED
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PROSPECTIVE, CONTROLLED, RANDOMIZED MULTI-CENTER STUDY ON THE USEFULNESS OF FLUORESCENCE IN THYROID SURGERY
• Actual Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluorescence in thyroid surgery Patients undergoing thyroid surgery with cervical fluorescence.	Procedure: Fluorescence in thyroid surgery; Fluorescence in thyroid surgery
No Intervention: No Fluorescence in thyroid surgery patients undergoing thyroid surgery without cervical fluorescence.

Outcome Measures

Primary Outcome Measures

1. Type of surgery performed [Up to 12 months.]

   total thyroidectomy/hemithyroidectomy; lymphadenectomy

2. Number of parathyroid glands identified before the use of AF (Autofluorescence) [Up to 12 months.]

   Gland count

3. Number and location of parathyroid glands identified with the use of FA (Autofluorescence) [Up to 12 months.]

   Gland count

4. Quantification of each parathyroid gland with AF(Autofluorescence) [Up to 12 months.]

   (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

5. Number of glands accidentally removed. [Up to 12 months.]

   Gland count

6. Number of autotransplanted glands. [Up to 12 months.]

   Gland count

7. Surgical time. [Up to 12 months.]

   Hours of surgery

8. Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve) [Up to 12 months.]

   Number of surgeries using autofluorescence

9. Concentration of PTH and calcium corrected by albumin and/or ionic [4, 24 Hours]

   Value in analytics

10. Concentration of PTH and calcium corrected by albumin and/or ionic [6,12 Months]

    Value in analytics

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia		Spain	30120

Sponsors and Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Investigators

• Principal Investigator: Beatriz Febrero, MD, HCUVA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• ClinicalTrials.gov Identifier: NCT06011369
• Other Study ID Numbers: IMIB-SPAFLUO
• First Posted: Aug 25, 2023
• Last Update Posted: Aug 25, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroid Diseases

Study Results

No Results Posted as of Aug 25, 2023