Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
|ClinicalTrials.gov Identifier: NCT01649206|
Recruitment Status : Completed
First Posted : July 25, 2012
Last Update Posted : July 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Nodule||Procedure: Percutaneous Radiofrequency Thermal Ablation||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study|
|Study Start Date :||January 2010|
|Primary Completion Date :||January 2011|
|Study Completion Date :||June 2011|
Experimental: Group A: RTA
Percutaneous Radiofrequency Thermal Ablation (RTA).
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.
No Intervention: Group B: untreated
No treatment, only follow-up
- Change from baseline in TN volume [ Time Frame: 12 months ]Evaluation of TN volume by using Ultrasonography.
- Efficacy on TN-related neck symptoms [ Time Frame: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months. ]Evaluation of TN-related neck symptoms scored separately as follows: 0 (absent), 1 (moderate), and 2 (severe). The sum of the individual scores generates a final score (SYS score) ranging from 0 to 6.
- Efficacy on TN hyperfunction [ Time Frame: Efficacy on TN-related neck symptoms Time Frame: (FDAAA) From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months. ]Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.
- Safety [ Time Frame: At 1, 3, 6, 12 months after baseline. ]
Assessment of local impairment (pain, oedema, skin damage). Assessment of thyroid dysfunction by measuring serum concentrations of fT3, fT4, TSH.
Assessment of thyroid autoimmunity (anti-Thyroglobulin and anti-Thyroperoxidase antibodies).
- Change from baseline in TN volume [ Time Frame: 1 month ]Evaluation of TN volume by using Ultrasonography
- Change from baseline in TN volume [ Time Frame: 3 months ]Evaluation of TN volume by using Ultrasonography
- Change from baseline in TN volume [ Time Frame: 6 months ]Evaluation of TN volume by using Ultrasonography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649206
|"Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology|
|Naples, Italy, 80131|
|Principal Investigator:||Annamaria Colao||"Federico II" University of Naples|