Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results
Information source: Elesta S.R.L.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Thyroid Nodule
Intervention: Percutaneous Laser Ablation (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Elesta S.R.L.
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.
Clinical Details
Official title: Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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)
Secondary outcome: Assessment of short-term and long-term PLA safety, tolerability and reproducibility.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Azienda Ospedaliera di Perugia - Osp. S.Maria della Misericordia, Perugia 06126, Italy; Recruiting
Pierpaolo De Feo, MD, Phone: 075-5783673, Ext: +39, Email: defeo@dimisem.med.unipg.it
Azienda Ospedaliero-Universitaria di Pisa - Presidio di Cisanello, Pisa 56124, Italy; Recruiting
Aldo Pinchera, MD, Phone: 050-544723, Ext: +39, Email: a.pinchera@endoc.med.unipi.it
Arcispedale S. Maria Nuova, Reggio Emilia 42100, Italy; Recruiting
Roberto Valcavi, MD, Phone: 0522-296630, Ext: +39, Email: roberto.valcavi@asmn.re.it
Ospedale Regina Apostolorum, Albano Laziale, ROMA 00041, Italy; Recruiting
Giancarlo Bizzarri, MD, Phone: 06-93298824, Ext: +39, Email: bizzarrigiancarlo@libero.it
Additional Information
Related 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.
Starting date: November 2008
Ending date: December 2011
Last updated: March 6, 2009
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