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Study of Usefulness of Fluorescence in Thiroid Surgery (ECA_SPAFLUO)

Primary Purpose

Thyroid Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Fluorescence in thyroid surgery
Sponsored by
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluorescence in thyroid surgery

No Fluorescence in thyroid surgery

Arm Description

Patients undergoing thyroid surgery with cervical fluorescence.

patients undergoing thyroid surgery without cervical fluorescence.

Outcomes

Primary Outcome Measures

Type of surgery performed
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Gland count
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Gland count
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
Number of glands accidentally removed.
Gland count
Number of autotransplanted glands.
Gland count
Surgical time.
Hours of surgery
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Number of surgeries using autofluorescence
Concentration of PTH and calcium corrected by albumin and/or ionic
Value in analytics
Concentration of PTH and calcium corrected by albumin and/or ionic
Value in analytics

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
September 1, 2023
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT06011369
Brief Title
Study of Usefulness of Fluorescence in Thiroid Surgery
Acronym
ECA_SPAFLUO
Official Title
A Prospective , Controlled, Randomized Multi-center Study on the Usefulness of Fluorescence in Thyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
PROSPECTIVE, CONTROLLED, RANDOMIZED
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluorescence in thyroid surgery
Arm Type
Experimental
Arm Description
Patients undergoing thyroid surgery with cervical fluorescence.
Arm Title
No Fluorescence in thyroid surgery
Arm Type
No Intervention
Arm Description
patients undergoing thyroid surgery without cervical fluorescence.
Intervention Type
Procedure
Intervention Name(s)
Fluorescence in thyroid surgery
Intervention Description
Fluorescence in thyroid surgery
Primary Outcome Measure Information:
Title
Type of surgery performed
Description
total thyroidectomy/hemithyroidectomy; lymphadenectomy
Time Frame
Up to 12 months.
Title
Number of parathyroid glands identified before the use of AF (Autofluorescence)
Description
Gland count
Time Frame
Up to 12 months.
Title
Number and location of parathyroid glands identified with the use of FA (Autofluorescence)
Description
Gland count
Time Frame
Up to 12 months.
Title
Quantification of each parathyroid gland with AF(Autofluorescence)
Description
(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
Time Frame
Up to 12 months.
Title
Number of glands accidentally removed.
Description
Gland count
Time Frame
Up to 12 months.
Title
Number of autotransplanted glands.
Description
Gland count
Time Frame
Up to 12 months.
Title
Surgical time.
Description
Hours of surgery
Time Frame
Up to 12 months.
Title
Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)
Description
Number of surgeries using autofluorescence
Time Frame
Up to 12 months.
Title
Concentration of PTH and calcium corrected by albumin and/or ionic
Description
Value in analytics
Time Frame
4, 24 Hours
Title
Concentration of PTH and calcium corrected by albumin and/or ionic
Description
Value in analytics
Time Frame
6,12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatriz Febrero, MD
Phone
968 36 95 00
Email
beatriz.febrero@um.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Febrero, MD
Organizational Affiliation
HCUVA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Febrero, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Usefulness of Fluorescence in Thiroid Surgery

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