MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules

May 23, 2024 updated by: Man Him Matrix Fung, The University of Hong Kong

Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules, a Randomized Controlled Trial

Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). [1-3] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules.

Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized [4-9], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

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: Man Him, Matrix Fung, MBBS
  • Phone Number: +852-22554232
  • Email: mmhfung@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Man Him, Matrix Fung, MBBS
          • Phone Number: +852-22554232
          • Email: mmhfung@hku.hk
        • Principal Investigator:
          • Man Him, Matrix Fung, MBBS

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients >/=18 years of age
  2. Nodule maximal diameter ≥2cm and nodule volume <20ml
  3. Nodule being predominantly solid (≥80% solid)
  4. Confirmed benign nature of nodules, either by : two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
  5. Both functional and non-functional nodules are eligible.

Exclusion Criteria:

  1. Cytologically indeterminate nodules
  2. Nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
  3. current pregnancy or cardiac arrhythmias; presence of pacemaker or any medical condition that renders patient unfit for thermal ablation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiofrequency ablation treatment (RFA) to thyroid nodule
Participants who are undergo thyroid nodule treatment by RFA
Procedure: Ablation treatment of thyroid nodule
Use Radiofrequency or Microwave ablation device to treat thyroid nodule
Active Comparator: Microwave ablation treatment (MWA) to thyroid nodule
Participants who are undergo thyroid nodule treatment by MWA
Procedure: Ablation treatment of thyroid nodule
Use Radiofrequency or Microwave ablation device to treat thyroid nodule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the volume reduction ratio (VRR) of the first ablated nodule at each procedure at 12-months post-procedure
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measures nodule recurrence rate
Time Frame: 12-24 months
12-24 months
To measures thyroid nodule regrowth rate
Time Frame: 12-24 months
12-24 months
To measure cosmetic score by investigator (1-4)
Time Frame: 12-24 months
To measure cosmetic score from 1 to 4 (1 is No palpable goitre, 2 is Palpable goitre but invisible, 3 is Goitre only visible to experienced clinician, 4 is Easily visible goitre)
12-24 months
To measure the compressive symptom scores (from 0 - 100)
Time Frame: 12-24 months
compressive symptom score from 0 (no compression feeling) to 100 (the most compressive)
12-24 months
To measure swallowing impairment scores by questionnaire (SIS-6)
Time Frame: 12-24 months
Swallowing Impairment Index (SIS-6) is an assessment tool about swallowing dysfunction and symptom. It comprises six question items ranging from 0 (no impairment) to 24 (maximum impairment)
12-24 months
To measure pain score (0-10) after ablation treatment
Time Frame: 12-24 months
0 is no pain, 10 is the most painful
12-24 months
Change of quality of life by SF12 ver 2
Time Frame: 12-24 months
SF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life).
12-24 months

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

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 (Actual)

April 15, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 24-141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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