Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

• ClinicalTrials.gov Identifier: NCT00858104
• Recruitment Status: Completed
• First Posted: March 9, 2009
• Last Update Posted: May 26, 2014
• Sponsor: Elesta S.R.L.
• Information provided by (Responsible Party): Elesta S.R.L.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Nodule	Procedure: Percutaneous Laser Ablation	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: November 2008
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm	Intervention/treatment
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.; Other Names: Arcispedale S. Maria Nuova is using commercially available system EchoLaser XVG; (Integrated Ultrasound-Laser, Elesta, Italy). Other centers are using commercially available; systems MyLab70XV (Ultrasound, Esaote, Italy) and Smart1064 BS (Nd:Yag Laser,; DEKA, Italy). Disposable Fiber Optic devices : Bare Fiber PLA THY 2111, Bare Fiber PLA S; (Asclepion Laser Technologies GmbH, Germany).
No Intervention: 2; Follow-up

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Assessment of short-term and long-term PLA safety, tolerability and reproducibility. [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Italy

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

Sponsors and Collaborators

Elesta S.R.L.

More Information

Publications:

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Elesta S.R.L.
• ClinicalTrials.gov Identifier: NCT00858104
• Other Study ID Numbers: IALT-07
• First Posted: March 9, 2009
• Last Update Posted: May 26, 2014
• Last Verified: May 2014

Additional relevant MeSH terms:

Thyroid Nodule; Thyroid Diseases; Endocrine System Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms