Clinical trial NCT00858104: Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
Official title: Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Nodule
Lead sponsor: Elesta S.R.L.
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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;
2. 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;
3. to demonstrate reproducibility of results within different environments and under different operators;
4. 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.


Eligibility criteria: Inclusion Criteria:

* The presence of a single nodule or dominating nodule;
* A solid or mixed echo-structure with less than 20% fluid volume;
* A lesion volume between 5 and 18 ml (greatest diameter \> 3.0 cm and \<= 4 cm);
* Thyroid hormone and TSH serum levels within the normalcy value;
* 2 cytologically negative examinations for suspected neoplasia (British Thyroid Association, Second class THY)within the last six months;
* Calcitonin values within the normalacy value;
* Anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours.

Exclusion Criteria:

* Hyperfunctioning lesion (99mTc scintigraph);
* Autoimmune thyreopathy or elevation of autoantibodies;
* Active anticoagulant treatment or antiaggregation treatment.

Primary outcomes:
measure: 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)
timeFrame: 3 years
Secondary outcomes:
measure: Assessment of short-term and long-term PLA safety, tolerability and reproducibility.
timeFrame: 3 years
Other outcomes:
Locations:
city: Albano Laziale
country: Italy
facility: Ospedale Regina Apostolorum
state: Roma
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
Study officials:
References:
citation: Pacella CM, Bizzarri G, Guglielmi R, Anelli V, Bianchini A, Crescenzi A, Pacella S, Papini E. Thyroid tissue: US-guided percutaneous interstitial laser ablation-a feasibility study. Radiology. 2000 Dec;217(3):673-7. doi: 10.1148/radiology.217.3.r00dc09673.
citation: Dossing H, Bennedbaek FN, Karstrup S, Hegedus L. Benign solitary solid cold thyroid nodules: US-guided interstitial laser photocoagulation--initial experience. Radiology. 2002 Oct;225(1):53-7. doi: 10.1148/radiol.2251011042.
citation: Pacella CM, Bizzarri G, Spiezia S, Bianchini A, Guglielmi R, Crescenzi A, Pacella S, Toscano V, Papini E. Thyroid tissue: US-guided percutaneous laser thermal ablation. Radiology. 2004 Jul;232(1):272-80. doi: 10.1148/radiol.2321021368. Epub 2004 May 20.
citation: Dossing H, Bennedbaek FN, Hegedus L. Effect of ultrasound-guided interstitial laser photocoagulation on benign solitary solid cold thyroid nodules - a randomised study. Eur J Endocrinol. 2005 Mar;152(3):341-5. doi: 10.1530/eje.1.01865.
citation: Papini E, Guglielmi R, Bizzarri G, Graziano F, Bianchini A, Brufani C, Pacella S, Valle D, Pacella CM. Treatment of benign cold thyroid nodules: a randomized clinical trial of percutaneous laser ablation versus levothyroxine therapy or follow-up. Thyroid. 2007 Mar;17(3):229-35. doi: 10.1089/thy.2006.0204.
citation: Papini E, Rago T, Gambelunghe G, Valcavi R, Bizzarri G, Vitti P, De Feo P, Riganti F, Misischi I, Di Stasio E, Pacella CM. Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3653-9. doi: 10.1210/jc.2014-1826. Epub 2014 Jul 22.