Thyroid-dedicated internally-cooled wet electrode for benign thyroid nodules: experimental and clinical study

Abstract

Background: To assess the effects of radiofrequency ablation (RFA) using an internally-cooled wet (ICW) electrode in ex vivo bovine liver and evaluate the feasibility of the ICW electrode for benign thyroid nodules.

Methods: We developed an 18-gauge ICW electrode with a microhole at the distal tip for tissue infusion of chilled (0 - 4 °C) isotonic saline (rate = 1.5 ml/min). RFA using ICW and IC electrodes were performed in bovine livers (40 pairs, 1-cm active tip, 50 W, 1-min). We compared the morphological characteristics of ablation zones and presence of carbonization. Twenty patients with benign thyroid nodules larger than 5 ml were prospectively enrolled in a clinical study and underwent ultrasound-guided RFA with ICW electrodes. Ultrasound examinations, laboratory data, and symptom and cosmetic scores were evaluated preprocedure and 1 and 6 months after the procedure.

Results: In the ex vivo study, the ICW achieved significantly larger ablation zones than the IC (p<.001). In the clinical study, ICW electrodes were tolerable in all patients. At last follow-up, nodule volume had decreased from 15.6 ± 12.1 ml to 4.1 ± 4.3 ml (p<.001), and the mean volume reduction ratio (VRR) was 73.3 ± 13.7% at 6.0 months follow-up. Cosmetic and symptom scores were reduced from 3.52 ± 1.03 to 2.65 ± 0.88 and 3.10 ± 2.17 to 0.85 ± 0.99 (both p<.001), respectively. After RFA, thyroid function was well preserved in all patients, and mean thyroglobulin level decreased from 36.6 ± 52.1 ng/ml to 26.9 ± 62.2 ng/ml. One patient experienced a temporary voice change that recovered within a week.

Conclusions: We developed a thyroid-dedicated ICW electrode that we showed to be feasible and effective in patients with benign thyroid nodules.