Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Обзор

Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.

Вмешательства

• Другое Data Collection
  Subjects with planned PED-TAE delivered via TriNav will receive their treatment following routine standard of care procedures. Post-procedural data obtained by a patient chart review will be collected in a study database. No additional study-specific interventions or visits outside of the routine clinical treatment will be performed.

Первичные конечные точки

• ThyPro-39 questionnaire [Срок оценки: 6 months]
• Procedure related adverse events [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Thyroid volume change [Срок оценки: 6 months]
• Change in TSH, T3 and T4 [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Adults, 18 years and or older and 89 years or younger
• Having undergone PED-TAE using the TriNav Infusion System
• Meeting one of the following criteria:

• Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule > 20 ml
• Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation
• Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure symptoms
• Bethesda category 2-3 (benign, or atypia or follicular lesion of undetermined significance) on 2 separate fine-needle aspiration biopsy (FNAB) results with a benign molecular profile with patient declining surgical resection

Критерии исключения

• Renal insufficiency
• Unable to tolerate angiography including pregnancy and severe allergy to contrast media
• Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
• <18 years old or >89 years old
• Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
• Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
• Prior thyroid thermal ablation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Sarasota Memorial Health Care System — Sarasota

Публикации

• Yilmaz S, Habibi HA, Yildiz A, Altunbas H. Thyroid Embolization for Nonsurgical Treatment of Nodular Goiter: A Single-Center Experience in 56 Consecutive Patients. J Vasc Interv Radiol. 2021 Oct;32(10):1449-1456. doi: 10.1016/j.jvir.2021.06.025. Epub 2021 Jul 10. PMID 34256121
• Wiener JD, de Vries AA. On the natural history of Plummer's disease. Clin Nucl Med. 1979 May;4(5):181-90. doi: 10.1097/00003072-197905000-00002. PMID 582300
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• Sjolin G, Watt T, Bystrom K, Calissendorff J, Cramon PK, Nystrom HF, Hallengren B, Holmberg M, Khamisi S, Lantz M, Planck T, Torring O, Wallin G. Long term outcome after toxic nodular goitre. Thyroid Res. 2022 Nov 1;15(1):20. doi: 10.1186/s13044-022-00138-0. PMID 36316779
• Russell JO, Desai DD, Noel JE, Hussein M, Toraih E, Seo S, Wolfe S, Omar M, Issa P, Orloff LA, Tufano RP, Kandil E. Radiofrequency ablation of benign thyroid nodules: A prospective, multi-institutional North American experience. Surgery. 2024 Jan;175(1):139-145. doi: 10.1016/j.surg.2023.07.046. Epub 2023 Nov 10. PMID 37953141
• Roque C, Santos FS, Pilli T, Dalmazio G, Castagna MG, Pacini F. Long-term Effects of Radioiodine in Toxic Multinodular Goiter: Thyroid Volume, Function, and Autoimmunity. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa214. doi: 10.1210/clinem/dgaa214. PMID 32320467
• Paschke R. Molecular pathogenesis of nodular goiter. Langenbecks Arch Surg. 2011 Dec;396(8):1127-36. doi: 10.1007/s00423-011-0788-5. Epub 2011 Apr 14. PMID 21487943
• Moon JH, Hyun MK, Lee JY, Shim JI, Kim TH, Choi HS, Ahn HY, Kim KW, Park DJ, Park YJ, Yi KH. Prevalence of thyroid nodules and their associated clinical parameters: a large-scale, multicenter-based health checkup study. Korean J Intern Med. 2018 Jul;33(4):753-762. doi: 10.3904/kjim.2015.273. Epub 2017 Jul 7. PMID 28859466

Идентификаторы

NCT: NCT06868459 · 24-ENT-97

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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