GuiArte: Usefulness of ICG Angiography-Guided Thyroidectomy for Preserving Parathyroid Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
To assess the appearance of postoperative hypoparathyroidism, a systematic determination of PTH and corrected calcium values will be carried out the morning after the intervention.
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 < 8 mg/dL.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Procedure: 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
|
| No Intervention: 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 |
Outcome Measures
Primary Outcome Measures
- Rate of participants with postoperative hypocalcemia [1 year]
Comparison of postoperative hypocalcemia between the two groups. It is considered hypocalcemia in the presence of symptoms of hypocalcemia or less than 1.8mmol/L in asymptomatic patients.
Secondary Outcome Measures
- Rate of participants with severe and permanent hypocalcemia [1 year]
Comparison of the occurrence of severe and permanent hypocalcemia after total thyroidectomy between the two groups. Severe hypocalcemia is considered when vitamin D is added to the treatment with calcium. Permanent hypocalcemia is defined when it lasts more than 12 months.
- Number of parathyroid glands identified and preserved [1 year]
Comparison of the number of parathyroid glands identified, left in situ and with an ICG score of 2 after total thyroidectomy between the two groups. The outcomes are recorded with a number from 0 to 4 to each item.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients ≥ 18 years of age with a surgical indication for total thyroidectomy with or without central cervical lymph node dissection due to thyroid pathology.
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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:
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Previous thyroid or parathyroid surgery
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Severe hepatic dysfunction
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Renal dysfunction
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Allergy or intolerance to ICG or iodine dyes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pablo Moreno Llorente | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
| 2 | Hospital UIniversitari de Bellvitge | L'Hospitalet De Llobregat | Barcelona | Spain | 08907 |
Sponsors and Collaborators
- Hospital Universitari de Bellvitge
Investigators
- Principal Investigator: Pablo Moreno, Hospital Universitari de Bellvitge
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- PR161/21