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

NCT ID: NCT05758038

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyroid Nodule (Benign)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

Patients with benign thyroid nodules undergo RFA

Radiofrequency ablation/Microwave ablation

Intervention Type PROCEDURE

thermal ablation by radiofrequency and Microwave

group 2

Patients with benign thyroid nodule undergo MWA

Radiofrequency ablation/Microwave ablation

Intervention Type PROCEDURE

thermal ablation by radiofrequency and Microwave

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency ablation/Microwave ablation

thermal ablation by radiofrequency and Microwave

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Gamal Mokhtar

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Omar Mokhtar, Assistant lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar Mokhtar, Assistant lecturer

Role: CONTACT

+201094584576

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33491515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28847173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32811597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30860579 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RFA/MWA in thyroid nodules.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cryoablation of Benign Thyroid Nodules: a Pilot Study
NCT06014229 ACTIVE_NOT_RECRUITING NA