title: Long-term efficacy of ultrasound-guided laser ablation for benign solid thyroid nodules. Results of a three-year multicenter prospective randomized trial.
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.
  
  
  METHODS
  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.
authors: 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.
authors: E
authors: E
authors: Papini
authors: T
authors: T
authors: Rago
authors: G
authors: G
authors: Gambelunghe
authors: R
authors: R
authors: Valcavi
authors: G
authors: G
authors: Bizzarri
authors: P
authors: P
authors: Vitti
authors: P
authors: P
authors: De Feo
authors: F
authors: F
authors: Riganti
authors: I
authors: I
authors: Misischi
authors: E
authors: E
authors: Di Stasio
authors: C M
authors: CM
authors: Pacella
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053685:Laser Therapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000000981:diagnostic imaging / Q000601:surgery; D011446:Prospective Studies; D016606:Thyroid Nodule / Q000000981:diagnostic imaging* / Q000601:surgery*; D013995:Time; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*