Thyroid Nodule (Benign)NCT05758038
US-guided RFA vs MWA in the Treatment of Benign Thyroid Nodules
An observational study of Thyroid Nodule (Benign), run by Assiut University.
Trial summary
To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Thyroid Nodule (Benign)
- What is being tested?
- Radiofrequency ablation/Microwave ablation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with benign thyroid nodules come to assiut university hospital for treatment
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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)
- Conditions
- Thyroid Nodule (Benign)
- Being tested
- Radiofrequency ablation/Microwave ablation
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation/Microwave ablationProcedure or surgery
thermal ablation by radiofrequency and Microwave
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Patients with benign thyroid nodules undergo RFA Receives: Procedure: Radiofrequency ablation/Microwave ablation | |
| group 2 | Patients with benign thyroid nodule undergo MWA Receives: Procedure: Radiofrequency ablation/Microwave ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms score
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
Measured: 2 years
thyroid nodule volume reduction
volume reduction ratio VRR assessed by Ultrasound = [(initial volume - final volume)/initial volume] x 100.
Measured: 2 years
cosmetic score
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thyroid Nodule (Benign)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Gamal Mokhtar, Assiut University
- Investigators
- Omar Mokhtar, Assistant lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758038
- Sponsor's protocol ID
- RFA/MWA in thyroid nodules.
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33491515Liu 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.
PubMed 28847173Erturk 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.
PubMed 32811597Deandrea 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.
PubMed 30860579
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US-guided Radiofrequency Ablation Versus Microwave Ablation in the Treatment of Benign Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05758038
- Acronym / sponsor ID
- RFA/MWA in thyroid nodules.
- Conditions
- Thyroid Nodule (Benign)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: Radiofrequency ablation/Microwave ablationPatients with benign thyroid nodules undergo RFA |
| group 2 | – | Procedure: Radiofrequency ablation/Microwave ablationPatients with benign thyroid nodule undergo MWA |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with benign thyroid nodules come to assiut university hospital for treatment
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation/Microwave ablationthermal ablation by radiofrequency and Microwave | Procedure or surgery | group 1, group 2 |
Primary outcome
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
thyroid nodule volume reduction
Time frame: 2 years
volume reduction ratio VRR assessed by Ultrasound = [(initial volume - final volume)/initial volume] x 100.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 33491515Russ 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.
- Background: PubMed 28847173Liu 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.
- Background: PubMed 32811597Erturk 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.
- Background: PubMed 30860579Deandrea 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Mokhtar, Assistant lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule (Benign), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Mokhtar, Assistant lecturer (+201094584576, ogamalm@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms score (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758038, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.