Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
NCT ID: NCT05573828
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
394 participants
INTERVENTIONAL
2022-10-11
2025-12-31
Brief Summary
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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.
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Detailed Description
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It will be considered that there is hypoparathyroidism when the patient presents symptoms of hypocalcaemia, when he has required the administration of calcium and/or vitamin D prior to this determination or when he presents corrected calcium values \< 1.8 mmol/L.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Angiography group
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.
ICG angiography to show vascular map of parathyroid glands
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
Control group
Patients who underwent post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the parathyroid glands
No interventions assigned to this group
Interventions
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ICG angiography to show vascular map of parathyroid glands
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
Yes
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Pablo Moreno Llorente
Head of Endocrine Surgery
Principal Investigators
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Pablo Moreno
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge
Locations
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Hospital UIniversitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Pablo Moreno Llorente
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PR161/21
Identifier Type: -
Identifier Source: org_study_id
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