Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Thyroid Nodule Clinical Trial

Official title:

Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858104
• Other study ID #: IALT-07
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2009
• Last updated: May 23, 2014
• Start date: November 2008
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Elesta S.R.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2013
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale Regina Apostolorum	Albano Laziale	Roma
Italy	Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia	Perugia
Italy	Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello	Pisa
Italy	Arcispedale S. Maria Nuova	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Elesta S.R.L.

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Døssing H, Bennedbaek FN, Hegedüs 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. — View Citation

Døssing H, Bennedbaek FN, Karstrup S, Hegedüs L. Benign solitary solid cold thyroid nodules: US-guided interstitial laser photocoagulation--initial experience. Radiology. 2002 Oct;225(1):53-7. — View 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. — View 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. Epub 2004 May 20. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		3 years	Yes
Secondary	Assessment of short-term and long-term PLA safety, tolerability and reproducibility.		3 years	Yes