aser treatment for thyroid benign tumors or follow-up

Not Applicable

• Conditions: benign thyroid nodule, goiter, dysphagia, dysphonia; C19.874.283; C06.405.117.119; C08.360.940.325

• Registration Number: RBR-9d6368
• Lead Sponsor: Instituto de Radiologia do Hospital das Clínicas / Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-18
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.