Microwave vs. Radiofrequency Ablation for Benign Thyroid Nodules: A Multicenter Randomized Controlled Trial Study

Overview

Compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. The study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.

Full Title of Study: “Clinical Trial of Microwave Ablation System”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 19, 2020

Detailed Description

Ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.Currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.Currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules. This study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.Radiofrequency ablation was used as the positive control.Follow-up was conducted at 1, 3, 6 and 12 months after ablation. The primary endpoint was the rate of nodule volume reduction at 12 months after surgery.

Interventions

  • Device: Ultrasound-guided Percutaneous Microwave Ablation
    • Ultrasound-guided Percutaneous Microwave Ablation
  • Device: Ultrasound-guided Percutaneous Radiofrequency Ablation
    • Ultrasound-guided Percutaneous Radiofrequency Ablation

Arms, Groups and Cohorts

  • Experimental: Group A
    • The group will use microwave ablation equipment to treat benign thyroid nodules.
  • Active Comparator: Group B
    • The group will use radiofrequency ablation equipment to treat benign thyroid nodules.

Clinical Trial Outcome Measures

Primary Measures

  • Volume reduction rate of thyroid nodules
    • Time Frame: up to 12 months.
    • volume reduction rate,VRR=(Volume before treatment – volume at follow-up)/Volume before treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Age>18 years and ≤75 years – The pathological diagnosis was benign thyroid nodules within 6 months – Diameter ≥2cm, solid > 80%, the number of multiple nodules≤ 3 – Participate voluntarily and sign the informed consent Exclusion Criteria:

  • Coagulation mechanism disorder or bleeding tendency – Patients with severe cardiopulmonary insufficiency – Blood pressure cannot be effectively controlled – abnormal liver function – Blood glucose cannot be effectively controlled – Abnormal thyroid function – Allergic history of ultrasound contrast agent – Suspicious lymph node metastasis in the cervical region – Abnormal contralateral vocal cord function – Pregnant and lactating women – Have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment – The researchers believe that there are any other factors that are not suitable for inclusion or that affect participants' participation in the study. – Patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yu Jie, Associate chief physician – Chinese PLA General Hospital
  • Overall Official(s)
    • Jie Yu, Doctor, Principal Investigator, Chinese PLA General Hospital

References

Rastogi A, Bhadada SK, Bhansali A. Nodular goiter with multiple cystic and solid swellings. Indian J Endocrinol Metab. 2012 Jul;16(4):651-3. doi: 10.4103/2230-8210.98034.

Kihara M, Hirokawa M, Masuoka H, Yabuta T, Shindo H, Higashiyama T, Fukushima M, Yamada O, Takamura Y, Ito Y, Kobayashi K, Miya A, Miyauchi A. Evaluation of cytologically benign solitary thyroid nodules by ultrasonography: a retrospective analysis of 1877 cases. Auris Nasus Larynx. 2013 Jun;40(3):308-11. doi: 10.1016/j.anl.2012.09.007. Epub 2012 Oct 24.

Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiology. 2005 Jul;236(1):132-9. doi: 10.1148/radiol.2361031249.

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