Thyroid Artery Embolization for the Treatment of Compressive Goiters.

Официальное название

Thyroid Artery Embolization for the Treatment of Compressive Goiters: a Prospective Cohort Study.

Обзор

Very few studies have investigated TAE as a treatment for goiter with compressive symptoms. What is the efficacy and safety of TAE for the treatment of compressive goiters in a population ineligible for or refusing standard therapy? This is a prospective interventional cohort study that will allow us to standardize imaging by improving quality data collection and fellow-up to assess the efficacy of TAE for compressive symptoms of nodular goiters. Not only to corroborate current emerging results but clearly define the expected results for this technique.

Подробное описание

This study is a prospective interventional cohort study.

The prospective cohort setting allows us to evaluate the direct effect of TAE on a series of patients on a longer period and to strengthen the retrospective data previously documented in other studies.

Included patients will have compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter.

They have to be Ineligible for surgery/ablative treatments or preference for TAE over other treatments.

There is no comparative group in our study as it aims to prove that TAE is effective and safe in a "nonsurgical" population, a population in which other alternatives lack or are refused by the patient.

Our sampling method will be a non-probabilistic convenience sampling. Patients will be recruited in an outpatient setting by the patient's treating endocrinologist or otolaryngologist.

Вмешательства

• Процедура Thyroid Artery Embolization
  Interruption of blood flow that supplies thyroid nodule using embolization technique.

Первичные конечные точки

• Change in Thyroid nodule volume [Срок оценки: Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.]

Вторичные конечные точки (4)

• Change in symptoms after TAE. [Срок оценки: Follow-ups at 3 months, 6 months and 12 months post-op.]
• Safety level of TAE in compressive goiter: Adverse Events report [Срок оценки: Day of embolisation; Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.]
• Safety level of TAE in compressive goiter: thyroid function tests [Срок оценки: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.]
• Safety level of TAE in compressive goiter: parathyroid function tests [Срок оценки: At baseline visit, approximately 48 hours after the intervention, and 6 weeks, 3 months, 6 months and 12 months after the intervention. More tests can be done according to the treating physician.]

Критерии участия

Критерии включения

• Patient with compressive symptoms or significant tracheal or oesophageal compression at risk of causing symptoms attributed to a goiter AND
• Ineligible for surgery/ablative treatments or preference for TAE over other treatments AND
• TiRADS category 1, 2, 3 or 4 AND
• Bethesda categories I or III on 2 different biopsies OR Bethesda II on one biopsy AND
• Patient at least 18 years old.

Критерии исключения

• Comorbidities precluding endovascular procedure OR
• TiRADS category 5 OR
• Bethesda categories IV, V, VI on biopsy OR
• Refusal of the patient to participate OR
• Uncontrolled severe hyperthyroidism OR
• Minor patient.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke

Публикации

• Ramos HE, Braga-Basaria M, Haquin C, Mesa CO, Noronha Ld, Sandrini R, Carvalho Gde A, Graf H. Preoperative embolization of thyroid arteries in a patient with large multinodular goiter and papillary carcinoma. Thyroid. 2004 Nov;14(11):967-70. doi: 10.1089/thy.2004.14.967. PMID 15671777
• Bonnici M, Nevin C, Boo S. Thyroid ima artery embolization for the treatment of Graves' disease and thyroid storm. Radiol Case Rep. 2023 May 28;18(8):2641-2644. doi: 10.1016/j.radcr.2023.04.044. eCollection 2023 Aug. PMID 37273723
• Xiao H, Zhuang W, Wang S, Yu B, Chen G, Zhou M, Wong NC. Arterial embolization: a novel approach to thyroid ablative therapy for Graves' disease. J Clin Endocrinol Metab. 2002 Aug;87(8):3583-9. doi: 10.1210/jcem.87.8.8723. PMID 12161479
• Galkin EV, Grakov BS, Protopopov AV. [First clinical experience of radio-endovascular functional thyroidectomy in the treatment of diffuse toxic goiter]. Vestn Rentgenol Radiol. 1994 May-Jun;(3):29-35. Russian. PMID 7985368
• McDermott MT. Hyperthyroidism. Ann Intern Med. 2020 Apr 7;172(7):ITC49-ITC64. doi: 10.7326/AITC202004070. PMID 32252086
• Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25. PMID 23096937
• Guan SH, Wang H, Teng DK. Comparison of ultrasound-guided thermal ablation and conventional thyroidectomy for benign thyroid nodules: a systematic review and meta-analysis. Int J Hyperthermia. 2020;37(1):442-449. doi: 10.1080/02656736.2020.1758802. PMID 32369708
• Papini E, Gugliemi R, Pacella CM. Laser, radiofrequency, and ethanol ablation for the management of thyroid nodules. Curr Opin Endocrinol Diabetes Obes. 2016 Oct;23(5):400-6. doi: 10.1097/MED.0000000000000282. PMID 27504993

Идентификаторы

NCT: NCT07360587 · 2025-5830

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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