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

Primary Purpose

Benign Thyroid Nodules, Ablation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ultrasound-guided Percutaneous Microwave Ablation
Ultrasound-guided Percutaneous Radiofrequency Ablation
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Thyroid Nodules focused on measuring microwave, thyroid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Volume reduction rate of thyroid nodules
volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment

Secondary Outcome Measures

Full Information

First Posted
August 5, 2019
Last Updated
March 2, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04046354
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 19, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Thyroid Nodules, Ablation
Keywords
microwave, thyroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The group will use microwave ablation equipment to treat benign thyroid nodules.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The group will use radiofrequency ablation equipment to treat benign thyroid nodules.
Intervention Type
Device
Intervention Name(s)
Ultrasound-guided Percutaneous Microwave Ablation
Intervention Description
Ultrasound-guided Percutaneous Microwave Ablation
Intervention Type
Device
Intervention Name(s)
Ultrasound-guided Percutaneous Radiofrequency Ablation
Intervention Description
Ultrasound-guided Percutaneous Radiofrequency Ablation
Primary Outcome Measure Information:
Title
Volume reduction rate of thyroid nodules
Description
volume reduction rate，VRR=(Volume before treatment - volume at follow-up)/Volume before treatment
Time Frame
up to 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Yu, Doctor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22837936
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.
Results Reference
background
PubMed Identifier
23103151
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.
Results Reference
background
PubMed Identifier
15987969
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.
Results Reference
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Microwave vs. Radiofrequency Ablation for Benign Thyroid Nodules: A Multicenter Randomized Controlled Trial Study

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