Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations.
During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects.
Aim of the study:
- to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy;
- to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
- to demonstrate reproducibility of results within different environments and under different operators;
- to validate eventual presence of major or minor side effects.
To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results|
- Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Assessment of short-term and long-term PLA safety, tolerability and reproducibility. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Laser thermal ablation
Procedure: Percutaneous Laser Ablation
Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.
No Intervention: 2
|Ospedale Regina Apostolorum|
|Albano Laziale, Roma, Italy, 00041|
|Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia|
|Perugia, Italy, 06126|
|Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello|
|Pisa, Italy, 56124|
|Arcispedale S. Maria Nuova|
|Reggio Emilia, Italy, 42100|