Combined Vacuum-Assisted Excision and Thermal Ablation for Symptomatic Benign Thyroid Nodules: A Pilot Study

Summary

This protocol describes ultrasound-guided combined vacuum-assisted excision and microwave thermal ablation for symptomatic benign thyroid nodules with persistent cosmetic or compressive symptoms at least 12 months after initial thermal ablation. In this exploratory pilot study, VAE-TA was technically feasible and achieved substantial short-term nodule volume reduction without major procedure-related complications.

Abstract

Thyroid nodules are a common clinical condition, while thermal ablation (TA) has emerged as a minimally invasive alternative to surgery. Single-session ablation often fails to achieve complete symptomatic resolution in large, hypervascular nodules. Post-ablation carbonization further limits volumetric resorption, necessitating optimized therapeutic strategies. This pilot study aimed to evaluate the feasibility, safety, and preliminary efficacy of combined vacuum-assisted excision and thermal ablation (VAE-TA) for symptomatic benign thyroid nodules refractory to initial ablation. From December 2023 to January 2025, five patients underwent VAE-TA at a single center. Inclusion criteria included persistent symptoms ≥12 months post-initial ablation and confirmed benignity via fine-needle aspiration. The procedure involved ultrasound-guided vacuum-assisted excision of post-ablation fibrotic tissue followed by microwave ablation. Primary outcomes included feasibility and safety, while secondary outcomes focused on volume reduction rate (VRR) and symptom improvement. Patients were followed up at 1 and 6 months. These preliminary findings suggest that VAE-TA may be a feasible, minimally invasive salvage approach for selected symptomatic benign thyroid nodules with incomplete response to initial ablation, although larger, controlled studies with longer follow-up are required.

Introduction

Thyroid nodules (TNs) represent a prevalent clinical entity, with the majority being benign and asymptomatic, warranting active surveillance alone¹. However, approximately 20% of benign thyroid nodules (BTNs) exhibit progressive growth, leading to compressive symptoms or cosmetic concerns that necessitate intervention². For such nodules, active intervention is warranted, and partial thyroidectomy remains the conventional therapeutic standard³. The 2021 guidelines for thermal ablation of thyroid nodules, jointly published by the European thyroid association (ETA) and the Korean society of thyroid r....

Protocol

This prospective exploratory pilot study was conducted at Beijing Friendship Hospital, Capital Medical University. The study protocol was approved by the Ethics Committee of Beijing Friendship Hospital, Capital Medical University (approval number: 2022–P2–035–02). Written informed consent was obtained from all participants before enrollment and before the VAE-TA procedure. The signed consent forms were stored in the study file and the medical record. From December 2023 to January 2025, five patients with symptomatic benign thyroid nodules underwent ultrasound-guided combined vacuum-assisted excision and thermal ablation (VAE-TA). Because this was an exploratory techni....

Results

This single-arm, exploratory pilot series included 5 patients with 5 previously ablated benign thyroid nodules. No control group was included. The cohort consisted of one man and four women. The median age was 43 years, and the baseline nodule volume measured immediately before VAE-TA was 10.42 ± 13.75 mL, with a range of 1.53–37.63 mL. All patients had persistent symptom-related and/or cosmetic concerns after prior thermal ablation and met the predefined criteria for secondary intervention. Complete and traceable docume.......

Discussion

This exploratory pilot series describes an ultrasound-guided combined vacuum-assisted excision and thermal ablation protocol for selected patients with symptomatic benign thyroid nodules after prior thermal ablation. In this initial clinical experience, VAE-TA was technically completed in all 5 patients, and short-term follow-up showed reductions in nodule volume and possible improvements in symptom-related and cosmetic outcomes. However, because the study included only 5 patients, lacked a control group, and had a limit.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Mindray Resona 9 ultrasound system	Mindray Medical International, Shenzhen, China	Resona 9	Ultrasound system used for pre-procedural assessment and real-time procedural guidance.
High-frequency linear transducer	Mindray Medical International, Shenzhen, China	L9-3	Linear transducer; probe frequency set at 3–9 MHz.
Vacuum-assisted biopsy/excision needle, 12-G	Bard, USA	ECP017	Used for ultrasound-guided vacuum-assisted excision of central post-ablation fibrotic/necrotic tissue.
Microwave ablation system	Dewen Medical, Nanjing, China	DW-M5T3	Microwave generator used for hemostatic and consolidative ablation.
Monopolar microwave applicator, 14 G, 10-mm active tip	Dewen Medical, Nanjing, China	DW-1805	Microwave applicator used for post-excision cavity ablation at 20 W.
Sulfur hexafluoride microbubble contrast agent (SonoVue)	Bracco, Milan, Italy	N/A	Contrast-enhanced ultrasound agent; 2.4 mL bolus followed by 5 mL saline flush.
Lidocaine hydrochloride injection, 2%	ShanDong Hualu pharmaaceutical Co.,Ltd,China	N/A	Used for local infiltration anesthesia; maximum dose did not exceed 4.5 mg/kg without epinephrine.
0.9% sodium chloride injection	Shanxi Nuocheng pharmaaceutical Co.,Ltd,China	N/A	Used for saline flush after SonoVue injection and for hydrodissection mixture preparation.
Lidocaine–saline hydrodissection mixture	Prepared in procedure room	N/A	Prepared by diluting 2% lidocaine with normal saline to a final concentration of approximately 0.1%–0.2%; 20–40 mL used according to nodule size/location.
Needle for hydrodissection, 23-G	Zhejiang Kindly MEDICAL Devices Co.,Ltd.,China	194141574	Used to inject the hydrodissection mixture into the perithyroidal space under real-time ultrasound guidance.
10% neutral buffered formalin	MAIGE, Jiangsu, China	CC002	Used to fix excised tissue fragments for pathological confirmation when tissue evaluation was required.
Specimen container	N/A	N/A	Used to collect, label, and store excised tissue fragments.
Manual compression materials / sterile gauze dressing	N/A	N/A	Used for at least 30 min manual compression after needle withdrawal; extended in 15-min intervals when indicated.
Vital signs monitor	Mindray Medical International, Shenzhen, China	N/A	Used to monitor heart rate, blood pressure, and oxygen saturation during and after the procedure.
Emergency airway and medication set	Procedure room emergency equipment	N/A	Available in the procedure room for bleeding, airway compromise, vasovagal reaction, or other emergencies; specify institutional emergency kit if required.
SPSS statistical software	IBM Corp., Armonk, NY, USA	Version 25.0	Used for descriptive statistical analysis and graph generation.