Recruiting NCT06733753
Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound-guided thermal ablation.
- Who it may be relevant to
- Registry conditions: Thyroid Nodule. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study
Overview
To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Detailed description
To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Interventions
- Procedure ultrasound-guided thermal ablation
microwave ablation, radio frequency ablation, laser ablation
Primary outcome measures
- volume reduction rate [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (7)
- rate of complications [Time frame: 1 week]
- rate of nodule regrowth [Time frame: through study completion, an average of 6 months]
- rate of change of thyroid function [Time frame: through study completion, an average of 6 months]
- rate of delayed surgery [Time frame: through study completion, an average of 1 year]
- cosmetic score [Time frame: through study completion, an average of 6 months]
- symptom score [Time frame: through study completion, an average of 6 months]
- rate of disappearance [Time frame: through study completion, an average of 6 months]
Eligibility criteria
Inclusion criteria
- confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
- no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
- refusal or ineligibility for surgery
- follow-up time ≥12 months
Exclusion criteria
- follicular neoplasm or malignancy findings on biopsy
- no suspicious of malignancy in US
- patients with contra-lateral vocal cord paralysis
- follow- up time less than 12 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Chinese PLA General Hospital — Beijing
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06733753 · 2024-656