Thyroid Nodules
Conditions
Keywords
Goiter, Thyroid Artery Embolization, thyroid nodule
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREThyroid Artery Embolization
Interruption of blood flow that supplies thyroid nodule using embolization technique.
Sponsors
Université de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
No needed.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thyroid nodule volume | Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op. | TAE effectiveness to reduce overall thyroid and nodular volumes in benign compressive goiters assessing changes in Nodule(s) volume(s) and Thyroid lobe volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms after TAE. | Follow-ups at 3 months, 6 months and 12 months post-op. | 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 : * Symptom severity * Functional limitations * Emotional and social impacts * This disease-specific focus supports patient-centered care, clinical decision-making, and outcomes research. * Target Population ThyPRO is validated for adults aged 18 and older with benign thyroid diseases. 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 |
| Safety level of TAE in compressive goiter: Adverse Events report | Day of embolisation; Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op. | Evaluate the safety of TAE for the treatment of benign compressive goiter using the Adverse Events report. |
| Safety level of TAE in compressive goiter: 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. | Monitoring of the effect of the intervention with thyroid function tests. |
| Safety level of TAE in compressive goiter: parathyroid 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. | Describe the effect of the procedure on parathyroid function with PTH and calcium blood levels. |
Countries
Canada
Contacts
CONTACTLaurent Fradet, MD FRCSC
Outcome results
None listed