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

March 4, 2023 updated by: Omar Gamal Mokhtar, Assiut University

US-guided Radiofrequency Ablation Versus Microwave Ablation in the Treatment of Benign Thyroid Nodules

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Omar Mokhtar, Assistant lecturer
  • Phone Number: +201094584576
  • Email: ogamalm@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with benign thyroid nodules come to assiut university hospital for treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
Patients with benign thyroid nodules undergo RFA
Procedure: Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave
group 2
Patients with benign thyroid nodule undergo MWA
Procedure: Radiofrequency ablation/Microwave ablation
thermal ablation by radiofrequency and Microwave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
symptoms score
Time Frame: 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
2 years
thyroid nodule volume reduction
Time Frame: 2 years
volume reduction ratio VRR assessed by Ultrasound = [(initial volume - final volume)/initial volume] x 100.
2 years
cosmetic score
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Omar Mokhtar, Assistant lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

March 4, 2023

First Posted (Estimate)

March 7, 2023

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFA/MWA in thyroid nodules.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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