Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thyroid Artery Embolization | Experimental | Patients with diagnosis of Goiter with compressive symptoms in which other alternatives lack or are refused by the patient himself. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thyroid Artery Embolization | Procedure | Interruption of blood flow that supplies thyroid nodule using embolization technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Thyroid nodule volume | TAE effectiveness to reduce overall thyroid and nodular volumes in benign compressive goiters assessing changes in Nodule(s) volume(s) and Thyroid lobe volume. | Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptoms after TAE. | Assess the impact of TAE on the symptoms related to the goiter as reported by the patient. Using ThyPRO score. ThyPRO is designed to evaluate physical, psychological, and social impairments caused by benign thyroid diseases by evaluating :
The ThyPRO consists of 85 items, grouped into: 13 multi-item domains: Goiter symptoms (11 items) Hyperthyroid symptoms (8) Hypothyroid symptoms (4) Eye symptoms (8) Tiredness (7) Cognitive impairment (6) Anxiety (6), Depressivity (7) Emotional susceptibility (9) Impaired social life (4), daily life (6), and sex life (2) Cosmetic complaints (6) 1 global QoL item Each question is rated on a 5-point Likert scale (0 = Not at all to 4 = Completely |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Fradet, MD FRCSC | Contact | +1-819-346-1110 | 14901 | Laurent.Fradet@USherbrooke.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke | Recruiting | Sherbrooke | Quebec | J1H5H3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15671777 | Background | 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. | |
| 37273723 | Background | 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. |
Not provided
Not provided
IPD information will only be shared after a formal request sent to the principal investigator's email address if the latter considers that the request is legally scientifically justified.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D006042 | Goiter |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
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. 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.
Not provided
Not provided
No needed.
Not provided
| Follow-ups at 3 months, 6 months and 12 months post-op. |
| Safety level of TAE in compressive goiter: Adverse Events report | Evaluate the safety of TAE for the treatment of benign compressive goiter using the Adverse Events report. | 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 | Monitoring of the effect of the intervention with thyroid function tests. | 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 | Describe the effect of the procedure on parathyroid function with PTH and calcium blood levels. | 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. |
| 12161479 | Background | 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. |
| 7985368 | Background | 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. |
| 32252086 | Background | McDermott MT. Hyperthyroidism. Ann Intern Med. 2020 Apr 7;172(7):ITC49-ITC64. doi: 10.7326/AITC202004070. |
| 23096937 | Background | 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. |
| 32369708 | Background | 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. |
| 27504993 | Background | 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. |
| 26462967 | Background | Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. |
| 15626055 | Background | Khairy GA. Solitary thyroid nodule: the risk of cancer and the extent of surgical therapy. East Afr Med J. 2004 Sep;81(9):459-62. doi: 10.4314/eamj.v81i9.9221. |
| 19601965 | Background | Guth S, Theune U, Aberle J, Galach A, Bamberger CM. Very high prevalence of thyroid nodules detected by high frequency (13 MHz) ultrasound examination. Eur J Clin Invest. 2009 Aug;39(8):699-706. doi: 10.1111/j.1365-2362.2009.02162.x. |
| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |