Study of Usefulness of Fluorescence in Thiroid Surgery (ECA_SPAFLUO)

September 1, 2023 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
        • Principal Investigator:
          • Beatriz Febrero, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of surgery performed
Time Frame: Up to 12 months.
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Up to 12 months.
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Time Frame: Up to 12 months.
Gland count
Up to 12 months.
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Time Frame: Up to 12 months.
Gland count
Up to 12 months.
Quantification of each parathyroid gland with AF(Autofluorescence)
Time Frame: 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
Up to 12 months.
Number of glands accidentally removed.
Time Frame: Up to 12 months.
Gland count
Up to 12 months.
Number of autotransplanted glands.
Time Frame: Up to 12 months.
Gland count
Up to 12 months.
Surgical time.
Time Frame: Up to 12 months.
Hours of surgery
Up to 12 months.
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Time Frame: Up to 12 months.
Number of surgeries using autofluorescence
Up to 12 months.
Concentration of PTH and calcium corrected by albumin and/or ionic
Time Frame: 4, 24 Hours
Value in analytics
4, 24 Hours
Concentration of PTH and calcium corrected by albumin and/or ionic
Time Frame: 6,12 Months
Value in analytics
6,12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Beatriz Febrero, MD, HCUVA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIB-SPAFLUO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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