Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Not Applicable

• Conditions: Thyroid Nodule
• Interventions: Device: Microwave Ablation

• Registration Number: NCT03057925
• Lead Sponsor: Wenjun Wu

Brief Summary

Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-17
• Last Update Posted: 2017-06-20
• Study Start: 2017-07-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age>18 years
• benign thyroid nodules(TYP 2)
• solid or predominantly solid(colloid component<30%)large (>3.0ml) thyroid nodules
• refusal and/or inefficacy of surgery

Exclusion Criteria

• pregnancy
• malignant or suspicious thyroid nodules

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Microwave Ablation	MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation

Primary Outcome Measures

Name	Time	Method
Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Change of the thyroid nodule volume assessed by using ultrasonography, the volume reduction ratio(VRR) was calculated by the equation: VRR%=\[(initial volume-final volume)\*100\]/initial volume

Secondary Outcome Measures

Name	Time	Method
Improved score on TN-related symptoms	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Evaluation of TN-related neck symptoms scored separately as follow:0(absent),1(moderate),2(severe). The sum of the individual scores generates a final score(SYS score) ranging from 0 to 6
Improved cosmetic grading score	From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months	Cosmetic problem evaluated by grading score(1,no palpable mass;2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem

Trial Locations

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China