Efficacy and Safety of RFA vs MWA for Treatment of Large Benign Thyroid Nodules, RCT

NCT07804862 | Active Not Recruiting

• 1 other identifier: UW 23-574
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients \>/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be eligible for enrollment in the study. They will need either a) two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or b) one benign fine needle biopsy and low suspicion characteristics on ultrasound. Both functional and non-functional nodules are eligible. Patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list.

Conditions

Ablation Techniques, RFA; Ablation Treatment; Benign Thyroid Nodules; Local Anaesthesia

Keywords

RFA; MWA; LA; compressive symptoms; Large benign thyroid nodules

Outcome Measures

Primary Outcomes (1)

• Volume reduction rate (VRR) of thyroid nodule at 6 months (%)

  To measure the volume reduction rate (VRR) of thyroid nodule at 6-month. volume of nodule= length(cm) x width(cm) x depth(cm) x (π / 6 ) VRR = \[(volume at baseline - volume at 6-month)/volume of baseline\] x 100%

  6 months

Secondary Outcomes (5)

• Volume reduction rate (VRR) of thyroid nodule at 12 months (%)

  12-months

• Changes in compressive symptom scores (0-100)

  12 months

• Changes in cosmetic symptom scores (1-4)

  12 months

• Peri-operative pain scores (0-10)

  12 months

• Complications from procedure including vocal cord palsy, bleeding, infection, nodule rupture, skin burn

  12 months

Study Arms (2)

Microwave ablation

EXPERIMENTAL

Apply microwave ablation to those large benign thyroid nodules for shrinkage purpose

Device: Microwave ablation

Radiofrequency ablation

EXPERIMENTAL

Apply radiofrequency ablation to those large benign thyroid nodules for shrinkage purpose

Device: Radiofrequency ablation alone

Interventions

Microwave ablation DEVICE

Ultrasound-guided thermal ablation will be performed using ECO Medical internally cooled MWA antennas (16 or 17 gauge) powered by the ECO Medical generator in accordance with the trans-isthmic 'moving shot' technique.

Also known as: MWA

Microwave ablation

Radiofrequency ablation alone DEVICE

Ultrasound-guided thermal ablation will be performed using STARmed internally cooled RFA electrodes (18 gauge) powered by the VIVA RF generator in accordance with the trans-isthmic 'moving shot' technique.

Also known as: RFA

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who have a solitary thyroid nodule ≥20ml in volume
• two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
• Both functional and non-functional nodules are eligible

You may not qualify if:

• have multiple nodules and planned simultaneous ablation
• cytologically indeterminate thyroid nodules
• nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
• current pregnancy or cardiac arrhythmias

Sponsors & Collaborators

• The University of Hong Kong: lead
• Columbia University: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (9)

• Cheng Z, Che Y, Yu S, Wang S, Teng D, Xu H, Li J, Sun D, Han Z, Liang P. US-Guided Percutaneous Radiofrequency versus Microwave Ablation for Benign Thyroid Nodules: A Prospective Multicenter Study. Sci Rep. 2017 Aug 25;7(1):9554. doi: 10.1038/s41598-017-09930-7.

  PMID: 28842651 RESULT

• Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.

  PMID: 29333159 RESULT

• He L, Zhao W, Xia Z, Su A, Li Z, Zhu J. Comparative efficacy of different ultrasound-guided ablation for the treatment of benign thyroid nodules: Systematic review and network meta-analysis of randomized controlled trials. PLoS One. 2021 Jan 20;16(1):e0243864. doi: 10.1371/journal.pone.0243864. eCollection 2021.

  PMID: 33471820 RESULT

• Hu K, Wu J, Dong Y, Yan Z, Lu Z, Liu L. Comparison between ultrasound-guided percutaneous radiofrequency and microwave ablation in benign thyroid nodules. J Cancer Res Ther. 2019;15(7):1535-1540. doi: 10.4103/jcrt.JCRT_322_19.

  PMID: 31939434 RESULT

• Guo DM, Chen Z, Zhai YX, Su HH. Comparison of radiofrequency ablation and microwave ablation for benign thyroid nodules: A systematic review and meta-analysis. Clin Endocrinol (Oxf). 2021 Jul;95(1):187-196. doi: 10.1111/cen.14438. Epub 2021 Mar 2.

  PMID: 33556187 RESULT

• Jin H, Fan J, Lu L, Cui M. A Propensity Score Matching Study Between Microwave Ablation and Radiofrequency Ablation in Terms of Safety and Efficacy for Benign Thyroid Nodules Treatment. Front Endocrinol (Lausanne). 2021 Mar 9;12:584972. doi: 10.3389/fendo.2021.584972. eCollection 2021.

  PMID: 33767666 RESULT

• Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14.

  PMID: 29962870 RESULT

• Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology. 2012 Jun;263(3):909-16. doi: 10.1148/radiol.12111300. Epub 2012 Mar 21.

  PMID: 22438360 RESULT

• Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol. 2013 Apr;23(4):1044-9. doi: 10.1007/s00330-012-2671-3. Epub 2012 Oct 25.

  PMID: 23096937 RESULT

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: December 5, 2023
• Primary Completion: October 1, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-08

Locations

HK (1)