具有压力逆行的逆行闭塞疗法,并栓塞用于控制甲状腺疾病(保护注册):多中心注册表
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
Florida
-
Jacksonville、Florida、美国、32224
- Mayo Clinic
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Sarasota、Florida、美国、34239
- Sarasota Memorial Health Care System
-
-
Georgia
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Atlanta、Georgia、美国、30322
- Emory University School of Medicine
-
-
Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane University School of Medicine
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients that may be included in the registry study are those who have undergone PED-TAE using TriNav at the selected study sites. Data will be collected on patients meeting eligibility criteria.
Study subjects will not be informed of their inclusion in this registry dataset, and the results of this research will not be reported to study subjects at the conclusion of the study.
描述
Inclusion Criteria:
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Adults, 18 years and or older and 89 years or younger
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Having undergone PED-TAE using the TriNav Infusion System
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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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:OTHER
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients who have undergone PED-TAE using the TriNav Infusion System at participating study sites.
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. |
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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ThyPro-39 questionnaire
大体时间:6 months
|
Change in quality of life as measured by ThyPro-39 questionnaire at 6-months (+/- 60). Responses to each statement are measured on a Likert scale ranging from '0= no symptoms or problems' to '4= severe symptoms or problems' based on the period of the last 4 weeks. Higher scores indicate greater impact on quality of life due to thyroid issues. |
6 months
|
|
Procedure related adverse events
大体时间:6 months
|
Safety as measured by the rate of procedure related adverse events as measured by SIR criteria at 2-weeks (+/- 7 days), 3- (+/- 30 days) and 6-months (+/- 60 days) post PED-TAE using TriNav treatment. |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Thyroid volume change
大体时间:6 months
|
Thyroid volume change based on 3D CT volumetry at 6-months (+/- 60 days) post-treatment |
6 months
|
|
Change in TSH, T3 and T4
大体时间:6 months
|
Change in TSH, T3 and T4 levels at 2-weeks (+/- 7 days), 3-(+/- 30 days) and 6-months (+/- 60 days) post-treatment |
6 months
|
合作者和调查者
调查人员
- 研究主任:Tamela Fonseca, PhD, RN, CCRC, NE-BC、Sarasota Memorial Health Care System
出版物和有用的链接
一般刊物
- Watt T, Cramon P, Hegedus L, Bjorner JB, Bonnema SJ, Rasmussen AK, Feldt-Rasmussen U, Groenvold M. The thyroid-related quality of life measure ThyPRO has good responsiveness and ability to detect relevant treatment effects. J Clin Endocrinol Metab. 2014 Oct;99(10):3708-17. doi: 10.1210/jc.2014-1322. Epub 2014 Jul 8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Elte JW, Bussemaker JK, Haak A. The natural history of euthyroid multinodular goitre. Postgrad Med J. 1990 Mar;66(773):186-90. doi: 10.1136/pgmj.66.773.186.
- Dean DS, Gharib H. Epidemiology of thyroid nodules. Best Pract Res Clin Endocrinol Metab. 2008 Dec;22(6):901-11. doi: 10.1016/j.beem.2008.09.019.
- Cheng KL, Liang KW, Lee HL, Wang HY, Shen CY. Thyroid artery embolization of large solitary symptomatic benign thyroid nodules through transradial approach. Quant Imaging Med Surg. 2023 Aug 1;13(8):5355-5361. doi: 10.21037/qims-22-1385. Epub 2023 May 30.
- Campenni A, Avram AM, Verburg FA, Iakovou I, Hanscheid H, de Keizer B, Petranovic Ovcaricek P, Giovanella L. The EANM guideline on radioiodine therapy of benign thyroid disease. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3324-3348. doi: 10.1007/s00259-023-06274-5. Epub 2023 Jul 3.
- Berghout A, Wiersinga WM, Smits NJ, Touber JL. Interrelationships between age, thyroid volume, thyroid nodularity, and thyroid function in patients with sporadic nontoxic goiter. Am J Med. 1990 Nov;89(5):602-8. doi: 10.1016/0002-9343(90)90178-g.
- Bahre M, Hilgers R, Lindemann C, Emrich D. Thyroid autonomy: sensitive detection in vivo and estimation of its functional relevance using quantified high-resolution scintigraphy. Acta Endocrinol (Copenh). 1988 Feb;117(2):145-53. doi: 10.1530/acta.0.1170145.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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