Clinical trial NCT05758038: US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules
Official title: US-guided Radiofrequency Ablation Versus Microwave Ablation in the Treatment of Benign Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Nodule (Benign)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 50
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with benign thyroid nodules come to assiut university hospital for treatment

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

Detailed 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)

Eligibility criteria: 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.

Primary outcomes:
measure: symptoms score
timeFrame: 2 years
measure: thyroid nodule volume reduction
timeFrame: 2 years
measure: cosmetic score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Omar Mokhtar, Assistant lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.