Clinical trial NCT04046354: Microwave vs. Radiofrequency Ablation for Benign Thyroid Nodules: A Multicenter Randomized Controlled Trial Study
Official title: Clinical Trial of Microwave Ablation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Thyroid Nodules
Ablation
Keywords: microwave
thyroid
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Volume reduction rate of thyroid nodules
timeFrame: up to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Jie Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.