Study of Usefulness of Fluorescence in Thiroid Surgery

NCT06011369 | Unknown

• 1 other identifier: IMIB-SPAFLUO
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Surgery

Outcome Measures

Primary Outcomes (10)

• Type of surgery performed

  total thyroidectomy/hemithyroidectomy; lymphadenectomy

  Up to 12 months.

• Number of parathyroid glands identified before the use of AF (Autofluorescence)

  Gland count

  Up to 12 months.

• Number and location of parathyroid glands identified with the use of FA (Autofluorescence)

  Gland count

  Up to 12 months.

• 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.

• Number of glands accidentally removed.

  Gland count

  Up to 12 months.

• Number of autotransplanted glands.

  Gland count

  Up to 12 months.

• Surgical time.

  Hours of surgery

  Up to 12 months.

• Number of previous thyroidectomies performed with FA (Autofluorescence)(learning curve)

  Number of surgeries using autofluorescence

  Up to 12 months.

• Concentration of PTH and calcium corrected by albumin and/or ionic

  Value in analytics

  4, 24 Hours

• Concentration of PTH and calcium corrected by albumin and/or ionic

  Value in analytics

  6,12 Months

Study Arms (2)

Fluorescence in thyroid surgery

EXPERIMENTAL

Patients undergoing thyroid surgery with cervical fluorescence.

Procedure: Fluorescence in thyroid surgery

No Fluorescence in thyroid surgery

NO INTERVENTION

patients undergoing thyroid surgery without cervical fluorescence.

Interventions

Fluorescence in thyroid surgery PROCEDURE

Fluorescence in thyroid surgery

Fluorescence in thyroid surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

MeSH Terms

Interventions

Fluorescence

Intervention Hierarchy (Ancestors)

Luminescence; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena

Study Officials

• Beatriz Febrero, MD

  HCUVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Febrero, MD

CONTACT

968 36 95 00; beatriz.febrero@um.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PROSPECTIVE, CONTROLLED, RANDOMIZED

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 25, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)