US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules

Thyroid Nodule (Benign) Clinical Trial

Official title:

US-guided Radiofrequency Ablation Versus Microwave Ablation in the Treatment of Benign Thyroid Nodules

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05758038
• Other study ID #: RFA/MWA in thyroid nodules.
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Omar Mokhtar, Assistant lecturer
• Phone: +201094584576
• Email: ogamalm[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment

Description:

The thyroid nodule is one of the most common lesions in clinical practice and has been increasingly detected in approximately 50% of the general population by ultrasound (US) examination in the past two decades due to the widespread use of radiological imaging. Benign thyroid nodules (BTNs) proven cytologically by fine-needle aspiration biopsy (FNAB) account for 85 to 95% of all thyroid nodules. Despite the fact that the majority of thyroid nodules diagnosed are benign and do not cause significant clinical symptoms, some nodules may lead to compression-related symptoms. In addition, thyrotoxic symptoms may develop due to hyperfunctioning of some nodules. To date, surgical resection is the main treatment for thyroid nodules. However, it has serious drawbacks such as leading to excessive surgical trauma or hypothyroidism, influencing the aesthetic aspect of the neck, or increasing a post-operative recurrence rate. RFA has shown good efficacy and safety in the management of thyroid nodule related cosmetic problems and pressure symptoms. MWA is a newly developed local thermal ablation technique that has fast heating speed, strong coagulation ability and large ablation zone, and has become a great therapeutic method in heat ablation therapy (8) The advantages of ultrasound-guided minimally invasive ablation therapy over the traditional surgery include simpler operation and shorter treatment time. (8)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Solid or mixed nodules with predominant solid component with benign pathological result from US guided fine needle aspiration (FNAC).
• Symptomatic and/or cosmetic problems.
• Clinical thyrotoxicosis and hyperthyroidism caused by autonomously functioning thyroid nodules (AFTNs)
• Refusal or ineligible for surgery.
• Anxiety about a malignant transformation.

Exclusion Criteria:

• Malignant nodules on US.
• Cytological evidence for malignancy
• Patients with abnormal coagulation profile.
• previous surgery or medicine for the thyroid, and vocal cord palsy in the side contralateral to the target nodules.

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodule (Benign)

Intervention

Procedure:
• Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Deandrea M, Trimboli P, Garino F, Mormile A, Magliona G, Ramunni MJ, Giovanella L, Limone PP. Long-Term Efficacy of a Single Session of RFA for Benign Thyroid Nodules: A Longitudinal 5-Year Observational Study. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3751-3756. doi: 10.1210/jc.2018-02808. — View Citation

Erturk MS, Cekic B, Celik M. Microwave Ablation of Benign Thyroid Nodules: Effects on Systemic Inflammatory Response. J Coll Physicians Surg Pak. 2020 Jul;30(7):694-700. doi: 10.29271/jcpsp.2020.07.694. — View Citation

Liu YJ, Qian LX, Liu D, Zhao JF. Ultrasound-guided microwave ablation in the treatment of benign thyroid nodules in 435 patients. Exp Biol Med (Maywood). 2017 Sep;242(15):1515-1523. doi: 10.1177/1535370217727477. Epub 2017 Aug 28. — View Citation

Russ G, Ben Hamou A, Poiree S, Ghander C, Menegaux F, Leenhardt L, Buffet C. Learning curve for radiofrequency ablation of benign thyroid nodules. Int J Hyperthermia. 2021;38(1):55-64. doi: 10.1080/02656736.2021.1871974. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms score	symptoms score will be assessed by (visual analogue scale) a score from 1 to 10 will be given by the patient according to each symptom including (neck pain , dysphagia , foreign body sensation , discomfort and cough); 1 is the minimum score indicating the best outcome and 10 is the maximum score indicating worst outcome	2 years
Primary	thyroid nodule volume reduction	volume reduction ratio VRR assessed by Ultrasound = [(initial volume - final volume)/initial volume] x 100.	2 years
Primary	cosmetic score	cosmetic score will be measured by the physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem); 1 indicates the best outcome and 4 indicates the worst outcome	2 years