Thyroid Artery Embolization for the Treatment of Compressive Goiters.
ConditionThyroid Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Comorbidities precluding endovascular procedure OR
TiRADS category 5 OR
Bethesda categories IV, V, VI on biopsy OR
Refusal of the patient to participate OR
Trial design
Design model
Single group
Treatments tested in this trial
Thyroid Artery Embolization
Procedure/SurgeryInterruption of blood flow that supplies thyroid nodule using embolization technique.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Thyroid Artery EmbolizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.Secondary outcomes
1
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 : * 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
Time frame
Follow-ups at 3 months, 6 months and 12 months post-op.2
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.
Time frame
Day of embolisation; Follow-ups at 1 week, and 3 months, 6 months and 12 months post-op.3
Safety level of TAE in compressive goiter: thyroid function tests
Monitoring of the effect of the intervention with thyroid function tests.
Time frame
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.4
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov