benign thyroid nodule, goiter, dysphagia, dysphonia
Conditions
Interventions
treated group - participants: 21
procedure: ultrasound guided percutaneous laser ablation
one procedure per patient
follow-up with ultrasound end laboratory examination 06 months and 12 months after baseline.
control group - participants: 13
procedure: clinical follow up
follow-up with ultrasound end laboratory examination 06 months and 12 months after baseline.
Procedure/surgery
Sponsors
Instituto de Radiologia do Hospital das Clínicas / Faculdade de Medicina da Universidade de São Paulo
Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: solid or solid-cystic with less than 20% of liquid benign thyroid nodule at ultrasound; nodule volume between 5-18 mL; serum levels of thyroid hormone and TSH in the normal range values; two negative cytological evaluations for malignancy in the last 6 months; no thyroid autoimmunity expressed by ultrasound or auto-antibody elevation over 100% of the standard level; calcitonin level under normal range values; anticoagulant treatment interrupted;
Exclusion criteria
Exclusion criteria: age under 18 years; extensive goiter; cystic nodule; hyper functioning nodule; elevated TSH levels; autoimmune therapy; active anticoagulant therapy; cytological specimens with suspected malignancy; pregnancy and breast-feeding; thyroiditis; asymptomatic nodule;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary endpoint 1: 50% thyroid nodule volume reduction measured at ultrasound exam 6- and 12-months after laser ablation treatment compared to pre-treatment nodule volume measured at baseline ultrasound exams (pre-treatment) and compared to control group.;Primary endpoint 1 found: we found 50% thyroid nodule volume reduction measured at ultrasound exam 6- and 12-months after laser ablation treatment compared to pre-treatment nodule volume measured at baseline ultrasound exams (pre-treatment) and compared to control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary expected endpoint 1: thyroid function preservation by means of laboratory data analysis (TSH = 0.27-4.2 microIU/mL;T3 = 80-200 ng/dL; FT4 = 0.93 - 1.7 ng/dL) 100% similar or close to these range values, not statistically significant according to laboratory data identified by serum blood samples collected 6- and 12-months after laser ablation treatment of thyroid nodules and compared to baseline laboratory data as well as to control group.;Secondary expected endpoint 1: there was thyroid function preservation by means of laboratory data analysis (TSH = 0.27-4.2 microIU/mL;T3 = 80-200 ng/dL; FT4 = 0.93 - 1.7 ng/dL) 100% similar or close to these range values, not statistically significant according to laboratory data identified by serum blood samples collected 6- and 12-months after laser ablation treatment of thyroid nodules and compared to baseline laboratory data as well as to control group.;Secondary expected endpoint 2: at least 50% reduction of specific cervical signs and symptoms related to thyroid gland enlargement (hoarseness, disphagia, perception of cervical lump) identified in visual analog score-adapted questionnaires applied 6- and 12-months after laser ablation treatment and compared to questionnaires applied before treatment (baseline), as well as compared to control group.;Secondary expected endpoint 2: there was at least 50% reduction of specific cervical signs and symptoms related to thyroid gland enlargement (hoarseness, disphagia, perception of cervical lump) identified in visual analog score-adapted questionnaires applied 6- and 12-months after laser ablation treatment and compared to questionnaires applied before treatment (baseline), as well as compared to control group. | — |
Countries
Brazil
Contacts
Public ContactMaria Folgueira
Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq
Outcome results
None listed