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Santa Maria Nuova, Italy

Papini E.,Regina Apostolorum Hospital | Rago T.,University of Pisa | Gambelunghe G.,University of Perugia | Valcavi R.,Thyroid Disease Center | And 7 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Background: The aim of the present trial on ultrasound (US)-guided laser ablation therapy (LAT) of solid thyroid nodules is to assess long-term clinical efficacy, side effects, and predictability of outcomes in different centers operating with the same procedure.Patients: Two hundred consecutive patients were randomly assigned to a single LAT session (group 1,101 cases) or to follow-up (group 2, 99 cases) at four thyroid referral centers. Entry criteria were: solid thyroid nodule with volume of 6-17 mL, repeat benign cytological findings, normal thyroid function, no autoimmunity, and no thyroid gland treatment.Methods: Group 1: LAT was performed in a single session with two optical fibers, a 1064nm Nd-YAG laser source, and an output power of 3 W. Volume and local symptom changes were evaluated 1, 6,12,24, and 36 months after LAT. Side effects and tolerability of treatment were registered. Group 2: Follow-up with no treatment.Results: One patient was lost to follow-up in each group. Group 1: Volume decrease after LAT was -49 ± 22%, -59 ± 22%, -60 ± 24%, and -57 ± 25% at 6, 12, 24, and 36 months, respectively (P <.001 vs baseline). LAT resulted in a nodule reduction of >50% in 67.3% of cases (P <.001). Local symptoms decreased from 38 to 8% of cases (P =.002) and cosmetic signs from 72 to 16% of cases (P =.001). Baseline size, presence of goiter (P =.55), or US findings (fluid component ≤ 20% [P =.84], halo [P =.46], vascularization [P =.98], and calcifications [P =.06]) were not predictive factors of a volume decrease > 50%. The procedure was well tolerated in most (92%) cases. No changes in thyroid function or autoimmunity were observed. In group 2, nodule volume increased at 36 months (25 ± 42%; P =.04). The efficacy and tolerability of the procedure were similar in different centers.Conclusions: A single LAT treatment of solid nodules results in significant and persistent volume reduction and local symptom improvement, in the absence of thyroid function changes. Copyright © 2014 by the Endocrine Society.

Valcavi R.,Thyroid Disease Center | Riganti F.,Thyroid Disease Center | Bertani A.,Thyroid Disease Center | Formisano D.,Statistics and Clinical Epidemiology Unit | Pacella C.M.,Ospedale San Camillo
Thyroid | Year: 2010

Background: Percutaneous laser ablation (PLA) is a proposed therapeutic procedure for the management of benign thyroid nodules. However, long-term results are unknown. The aim of this study was to evaluate retrospectively the safety and effects of PLA treatment in patients with benign nonfunctioning thyroid nodules in a 3-year follow-up. Methods: One hundred twenty-two patients (95 women and 27 men; age 52.2±12.3 years) with benign cold thyroid solitary nodules or a dominant nodule within a normo-functioning multinodular goiter (volume range: 2.6-86.4mL) underwent thermal Nd:YAG laser ablation of thyroid nodular tissue by 1-4 optical fibers positioned into the tissue by 21-gauge needles under ultrasound real-time assistance. The setting was an interventional suite and outpatient endocrine clinics in a community hospital in Italy. Nodule volume, ablation volume, side effects, serum thyroid-stimulating hormone (TSH), free triiodothyronine, free thyroxine (fT4), thyroglobulin (Tg), anti-Tg, anti-thyroperoxidase antibodies, symptoms, and cosmetic signs were recorded. Results: Data are mean±standard deviation. Energy delivered was 8522±5365J with an output power of 3.1±0.5 W. Three years after PLA, nodule volume decreased from 23.1±21.3 to 12.5±18.8mL (-47.8%±33.1% of initial volume, p≤0.001). At day 1, TSH and fT4 values significantly changed (time 0 vs. day 1: TSH=1.16±1.06 vs. 0.62±0.81μU/mL, p≤0.001; fT4=11.68±1.88 vs. 13.20±3.32pg/mL, p≤0.01) and normalized within 1 month. No change in free triiodothyronine, thyroperoxidase antibodies, and Tg antibodies values was observed. Symptoms improved in 89 patients (73.0%), were unchanged in 28 (22.9%), and worsened in 5 (4.1%). Cosmetic signs improved in 87 patients (71.3%), were unchanged in 29 (23.8%), and worsened in 6 (4.9%). In 11 patients (9%), nodules regrew above baseline. Two patients (1.6%) experienced delayed (12-24 hours) laryngeal dysfunction with vocal cord motility recovery after 6-10 weeks. Two patients (1.6%) became hypothyroid and two patients (1.6%) hyperthyroid after PLA. Conclusions: After 3 years, the PLA technique achieved shrinkage of about 50% of the initial volume in a wide size range of benign cold thyroid nodules, with an improvement in local symptoms and signs. Side effects and failures were few although not negligible. PLA may be a new option for the management of benign cold thyroid nodules. Long-term controlled studies are required to establish the eligibility of patients for routine PLA. © Copyright 2010, Mary Ann Liebert, Inc.

Piana S.,IRCCS Arcispedale Santa Maria Nuova | Riganti F.,Thyroid Disease Center | Froio E.,IRCCS Arcispedale Santa Maria Nuova | Andrioli M.,Thyroid Disease Center | And 2 more authors.
Endocrine Pathology | Year: 2012

Ultrasound (US)-guided percutaneous laser ablation (LA) of benign thyroid nodules may be a potential alternative to surgery in patients with compressive symptoms, at high surgical risk, or in patients who refuse to undergo surgery. We evaluated the morphological effects of LA procedure on 22 patients and compared the cytolog-ical findings before and after LA with the histological features on surgical specimens. Twenty-two (4.9%; 19 women, three men, mean age 53.2 years) out of 452 patients treated with LA for benign thyroid nodules in our Hospital underwent surgery after LA procedure, either because nodule regrowth (treatment failure, n017) or indeterminate cytology (Thy3) after LA (n05). Morphological findings varied according to the time between LA and surgical intervention. Within 2 months, the area was occasionally cavitated and filled in with dark amorphous material. The inflammatory response was abundant and composed of neutrophils, lymphocytes, and macrophages. After 18 months or more since LA, the expected laser-induced histologic changes in thyroid morphology consisted of a well-defined area surrounded by a fibrous capsule and filled in by amorphous material. No significant pathologic features were found in the thyroid tissue adjacent to the treated area. Histological evaluation of thyroid tissues after LA shows that thermal damage is restricted to the ablated area, with no involvement of the nearby parenchyma. Our long-term histopathological findings indicate that LA treatment of benign thyroid nodules is safe, and patients undergoing LA may also be followed up by fine needle aspiration. © Springer Science+Business Media, LLC 2012.

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