Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function

NCT05573828 | Recruiting DMC

• 1 other identifier: PR161/21
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 2

Brief Summary

Transient and/or permanent hypoparathyroidism is the most frequent complication after total thyroidectomy. The identification of the parathyroid glands and a correct dissection during thyroidectomy have been postulated as key factors for their preservation and, consequently, to prevent hypoparathyroidism. The use of indocyanine green (ICG) fluorescence has reliably predicted parathyroid glands functionality in the immediate postoperative period. Recently, it is proposed that showing the vascular map of the parathyroid glands before performing the thyroidectomy by means of ICG angiography prevent the development of postoperative hypoparathyroidism. The goal of this multicentric study is to demonstrate that the preservation of the function of parathyroid glands is greater with use of arteriography than without. Patients will be divided in two groups. In the study group, the vascular map with ICG of parathyroid glands will be showed before performing the lobectomy. Once the lobectomy is done, the function of the glands will be assessed. Whereas in the control group, arteriography with ICG will only be carried out in order to check their function at the end of the lobectomy. Researchers will compare the study group and the control group to see which one present the lowest taxes of postoperative hypoparathyroidism.

Conditions

Iatrogenic Hypocalcemia

Keywords

hypocalcemia; ICG angiography; Guided thyroidectomy

Outcome Measures

Primary Outcomes (1)

• Rate of participants with postoperative permanent hypoparathyroidism

  Comparison of postoperative permanent hypoparathyroidism between the two groups. It is considered permanent hypoparathyroidism in the presence of symptoms of hypocalcemia or less than 1.8mmol/L of calcium in asymptomatic patients during more than 12 months.

  1 year

Secondary Outcomes (2)

• Rate of participants with severe permanent hypocalcemia

  1 year

• Number of parathyroid glands identified and preserved

  1 year

Study Arms (2)

Angiography group

EXPERIMENTAL

Patients undergoing initially ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid function.

Procedure: ICG angiography to show vascular map of parathyroid glands

Control group

NO INTERVENTION

Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands

Interventions

ICG angiography to show vascular map of parathyroid glands PROCEDURE

Using ICG angiography guided thyroidectomy to identify the vessels feeding the parathyroid glands and then perform the thyroidectomy. After it, ICG angiography is done to predict immediate parathyroid functio

Angiography group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.
• The patient or their guardian, where applicable, has the capacity to understand the study and agrees to participate in it, signing the corresponding informed consent document.

You may not qualify if:

• Previous surgical intervention on the thyroid or parathyroid gland.
• Associated hyperparathyroidism that requires associating a parathyroidectomy in the same surgical act.
• Patients with contraindications for the administration of ICG.
• Current drug use or alcohol abuse that could interfere with compliance with the study requirements.
• Participation in any other drug trials in the month prior to randomization.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (2)

Hospital UIniversitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Pablo Moreno Llorente

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (7)

• Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9.

  PMID: 24402815 BACKGROUND

• Vidal Fortuny J, Sadowski SM, Belfontali V, Karenovics W, Guigard S, Triponez F. Indocyanine Green Angiography in Subtotal Parathyroidectomy: Technique for the Function of the Parathyroid Remnant. J Am Coll Surg. 2016 Nov;223(5):e43-e49. doi: 10.1016/j.jamcollsurg.2016.08.540. Epub 2016 Aug 24. No abstract available.

  PMID: 27568330 BACKGROUND

• Falco J, Dip F, Quadri P, de la Fuente M, Prunello M, Rosenthal RJ. Increased identification of parathyroid glands using near infrared light during thyroid and parathyroid surgery. Surg Endosc. 2017 Sep;31(9):3737-3742. doi: 10.1007/s00464-017-5424-1. Epub 2017 Mar 31.

  PMID: 28364157 BACKGROUND

• Benmiloud F, Penaranda G, Chiche L, Rebaudet S. Intraoperative Mapping Angiograms of the Parathyroid Glands Using Indocyanine Green During Thyroid Surgery: Results of the Fluogreen Study. World J Surg. 2022 Feb;46(2):416-424. doi: 10.1007/s00268-021-06353-4. Epub 2021 Nov 6.

  PMID: 34743241 BACKGROUND

• Llorente PM, Francos Martinez JM, Barrasa AG. Intraoperative Parathyroid Hormone Measurement vs Indocyanine Green Angiography of Parathyroid Glands in Prediction of Early Postthyroidectomy Hypocalcemia. JAMA Surg. 2020 Jan 1;155(1):84-85. doi: 10.1001/jamasurg.2019.3652.

  PMID: 31617879 BACKGROUND

• Moreno-Llorente P, Garcia-Barrasa A, Pascua-Sole M, Videla S, Otero A, Munoz-de Nova JL. Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function. World J Surg. 2023 Feb;47(2):421-428. doi: 10.1007/s00268-022-06683-x. Epub 2022 Aug 9.

  PMID: 35945357 RESULT

• Moreno-Llorente P, Garcia-Gonzalez G, Pascua-Sole M, Garcia-Barrasa A, Videla S, Munoz-de-Nova JL; GuiArte Study Group. Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial. Front Endocrinol (Lausanne). 2023 May 8;14:1193900. doi: 10.3389/fendo.2023.1193900. eCollection 2023.

  PMID: 37223015 DERIVED

MeSH Terms

Conditions

Hypocalcemia

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Study Officials

• Pablo Moreno

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Moreno

CONTACT

661214772; 25108pml@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrine Surgery

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: October 11, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

ES (2)