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Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

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ClinicalTrials.gov Identifier: NCT03057925
Recruitment Status : Unknown
Verified June 2017 by Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
First Affiliated Hospital of Wenzhou Medical University
Information provided by (Responsible Party):
Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Device: Microwave Ablation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
 Device: Microwave Ablation
Ultrasound-guided Percutaneous Microwave Ablation
Other Name: Ultrasound-guided Percutaneous Microwave Ablation
No Intervention: Group B
untreated no treatment; regular ultrasonic image follow-up


Outcome Measures
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Primary Outcome Measures :
  1. Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation [ Time Frame: 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 :
  1. Improved score on TN-related symptoms [ Time Frame: 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

  2. Improved cosmetic grading score [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057925


Contacts
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Contact: Zimiao Chen 86-0577-88069715 zimiaochen@163.com

Locations
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China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Wenjun Wu    86-0577-55579381    wwju127@126.com   
Principal Investigator: Xiaojun Chen         
Sub-Investigator: Xiaohua Gong         
Sub-Investigator: Qi Zhou         
Sponsors and Collaborators
Wenjun Wu
First Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Xiaojun Chen Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wenjun Wu, associate chief physician, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03057925    
Other Study ID Numbers: wwju127
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wenjun Wu, First Affiliated Hospital of Wenzhou Medical University:
thyroid nodule
microwave ablation
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms