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

Phase 3
18 Years
87 Years
Not Enrolling
Thyroid Nodule

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Trial Information

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

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).

Inclusion Criteria:

- age > 18 years;

- benign thyroid nodules (TYR 2)

- solid or predominantly solid (colloid component < 30%) large (> 4.0 mL) thyroid

- refusal and/or inefficacy of surgery and/or radioiodine therapy.

Exclusion Criteria:

- pregnancy

- malignant or suspicious thyroid nodules.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in TN volume

Outcome Description:

Evaluation of TN volume by using Ultrasonography.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Annamaria Colao

Investigator Role:

Principal Investigator

Investigator Affiliation:

"Federico II" University of Naples


Italy: Ethics Committee

Study ID:




Start Date:

January 2010

Completion Date:

June 2011

Related Keywords:

  • Thyroid Nodule
  • Thyroid Nodule
  • Radiofrequency Thermal Ablation
  • Pressure symptoms
  • Hyperthyroidism
  • Thyroid Diseases
  • Thyroid Nodule