Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

NCT ID: NCT01649206

Last Updated: 2012-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-06-30

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).

Conditions

Thyroid Nodule

Keywords

Thyroid Nodule; Radiofrequency Thermal Ablation; Pressure symptoms; Hyperthyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: RTA

Percutaneous Radiofrequency Thermal Ablation (RTA).

Group Type: EXPERIMENTAL

Percutaneous Radiofrequency Thermal Ablation

Intervention Type: PROCEDURE

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.

Group B: untreated

No treatment, only follow-up

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Annamaria Colao

Department of Clinical and Molecular Endocrinology and Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annamaria Colao

Role: PRINCIPAL_INVESTIGATOR

"Federico II" University of Naples

Locations

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

Naples, , Italy

Countries

Italy

Other Identifiers

RTA-2012

Identifier Type: -

Identifier Source: org_study_id