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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Ablation; Benign Thyroid Nodules

Treatments: Device: Ultrasound-guided Percutaneous Microwave Ablation; Device: Ultrasound-guided Percutaneous Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04046354

KY2018001

Details and patient eligibility

About

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 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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 2 patient groups

Group A

Experimental group

Description:

The group will use microwave ablation equipment to treat benign thyroid nodules.

Treatment:

Device: Ultrasound-guided Percutaneous Microwave Ablation

Group B

Active Comparator group

Description:

The group will use radiofrequency ablation equipment to treat benign thyroid nodules.

Treatment:

Device: Ultrasound-guided Percutaneous Radiofrequency Ablation