Clinical trial NCT01649206: Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Official title: Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thyroid Nodule
Keywords: Thyroid Nodule
Radiofrequency Thermal Ablation
Pressure symptoms
Hyperthyroidism
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* benign thyroid nodules (TYR 2)
* solid or predominantly solid (colloid component \< 30%) large (\> 4.0 mL) thyroid nodules
* refusal and/or inefficacy of surgery and/or radioiodine therapy.

Exclusion Criteria:

* pregnancy
* malignant or suspicious thyroid nodules.

Primary outcomes:
measure: Change from baseline in TN volume
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy on TN-related neck symptoms
timeFrame: From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
measure: Efficacy on TN hyperfunction
timeFrame: 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.
measure: Safety
timeFrame: At 1, 3, 6, 12 months after baseline.
measure: Change from baseline in TN volume
timeFrame: 1 month
measure: Change from baseline in TN volume
timeFrame: 3 months
measure: Change from baseline in TN volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: "Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology
Study officials:
affiliation: "Federico II" University of Naples
name: Annamaria Colao
role: PRINCIPAL_INVESTIGATOR
References: