NCT01649206

Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 87 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs (one group to treat with RTA and a matched untreated control group) will be evaluated in term of TN volume, thyroid hormones and clinical symptoms.

Detailed description

Thyroid nodules (TNs) are very common in the general population, with a prevalence of about 50% in subjects older than 60 years undergoing neck ultrasound examination. The great majority of TNs are benign, but they can be responsible for pressure symptoms in the neck and result in discomfort and decreased quality of life. Large compressive TNs may result in life-threatening conditions because of the potential acute onset of respiratory crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure which has been firstly develop to treat patients with liver cancer and has been then used to treat both malignant and benign tumor nodules in many organs. RTA also represents a promising new approach for the management of TNs.The current prospective comparative study investigated the long-term effectiveness of RTA in patients with both toxic and non-toxic compressive TNs. Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in this study. Patients were randomised as follows: 20 patients were treated with a single RTA session (group A) and 20 patients did not receive any treatment and were only followed-up (group B).

Conditions

• Thyroid Nodule

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Radiofrequency Thermal Ablation	Percutaneous Radiofrequency Thermal Ablation (RTA) by using a RITA© StarBurst Talon needle (RITA Medical Systems, Fremont, CA). RTA is performed in each patient at Time 0.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-01-01
• Completion: 2011-06-01
• First posted: 2012-07-25
• Last updated: 2012-07-26

Locations

1 site across 1 country: Italy