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Trial Title:
US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules
NCT ID:
NCT05758038
Condition:
Thyroid Nodule (Benign)
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Radiofrequency ablation/Microwave ablation
Description:
thermal ablation by radiofrequency and Microwave
Arm group label:
group 1
Arm group label:
group 2
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)
Criteria for eligibility:
Study pop:
Patients with benign thyroid nodules come to assiut university hospital for treatment
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758038
