Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial

E Papini; T Rago; G Gambelunghe; R Valcavi; G Bizzarri; P Vitti; P De Feo; F Riganti; I Misischi; E Di Stasio; C M Pacella

doi:10.1210/jc.2014-1826

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.

Authors

E Papini¹, T Rago, G Gambelunghe, R Valcavi, G Bizzarri, P Vitti, P De Feo, F Riganti, I Misischi, E Di Stasio, C M Pacella

Affiliation

¹ Department of Endocrinology (E.P., I.M.), Regina Apostolorum Hospital, 00041 Albano Laziale, Italy; Department of Endocrinology (T.R., P.V.), University of Pisa, 56126 Pisa, Italy; Department of Medicine (G.G., P.D.F.), University of Perugia, Perugia, 06126 Italy; Thyroid Disease Center (R.V., F.R.), Arcispedale Santa Maria Nuova, 42123 Reggio Emilia, Italy; Institute of Biochemistry and Clinical Biochemistry (E.D.S.), Catholic University "Sacro Cuore," 00185 Rome, Italy; and Department of Diagnostic Imaging (G.B., C.M.P.), Regina Apostolorum Hospital, 00041 Albano Laziale, Italy.

PMID: 25050903
DOI: 10.1210/jc.2014-1826

Abstract

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 1064 nm 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.

Trial registration: ClinicalTrials.gov NCT00858104.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Aged
Ambulatory Care
Female
Follow-Up Studies
Humans
Laser Therapy / methods*
Male
Middle Aged
Neoplasms / diagnostic imaging
Neoplasms / surgery
Prospective Studies
Thyroid Nodule / diagnostic imaging*
Thyroid Nodule / surgery*
Time
Treatment Outcome
Ultrasonography, Interventional / methods*

Associated data

ClinicalTrials.gov/NCT00858104