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

Ablation Clinical Trial

Official title:

Clinical Trial of Microwave Ablation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04046354
• Other study ID #: KY2018001
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: December 31, 2021
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ablation
• Benign Thyroid Nodules
• Thyroid Diseases
• Thyroid Nodule

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume reduction rate of thyroid nodules	volume reduction rate,VRR=(Volume before treatment - volume at follow-up)/Volume before treatment	up to 12 months.