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

Not yet recruiting

• Conditions: Thyroid Nodule (Benign)

• Registration Number: NCT05758038
• Lead Sponsor: Assiut University

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)

Study Timeline

• Study First Submitted: 2023-02-12
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-04
• Last Update Submitted: 2023-03-04
• Study First Posted: 2023-03-07
• Last Update Posted: 2023-03-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thyroid nodule volume reduction	2 years	volume reduction ratio VRR assessed by Ultrasound = \[(initial volume - final volume)/initial volume\] x 100.
cosmetic score	2 years	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
symptoms score	2 years	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