Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

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

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Nodule
• Intervention / Treatment: Procedure: Percutaneous Radiofrequency Thermal Ablation

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • "Federico II" University of Naples, Department of Clinical and Molecular Endocrinology and Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy on TN-related neck symptoms	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.	From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.
Efficacy on TN hyperfunction	Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs.	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.
Safety	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).	At 1, 3, 6, 12 months after baseline.
Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	1 month
Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	3 months
Change from baseline in TN volume	Evaluation of TN volume by using Ultrasonography	6 months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Annamaria Colao, "Federico II" University of Naples

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Hyperthyroidism; Thyroid Nodule; Radiofrequency Thermal Ablation; Pressure symptoms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: RTA-2012