US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules
NCT ID: NCT05758038
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2023-03-01
2025-03-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group 1
Patients with benign thyroid nodules undergo RFA
Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave
group 2
Patients with benign thyroid nodule undergo MWA
Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave
Interventions
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Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
80 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Omar Gamal Mokhtar
Assistant Lecturer
Principal Investigators
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Omar Mokhtar, Assistant lecturer
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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RFA/MWA in thyroid nodules.
Identifier Type: -
Identifier Source: org_study_id
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