The Outcomes of Ultrasound-guided Thermal Ablation for Benign 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 Nodules. 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
The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules：A Multicenter Prospective Study
Overview
1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign 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]
- rate of nodule regrowth [Time frame: through study completion, an average of 1 months]
Secondary outcome measures (5)
- rate of complications [Time frame: 1 week]
- cosmetic score [Time frame: through study completion, an average of 6 months]
- symptom score [Time frame: through study completion, an average of 6 months]
- vital volume [Time frame: through study completion, an average of 6 months]
- total volume [Time frame: through study completion, an average of 6 months]
Eligibility criteria
Inclusion criteria
- \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months
Exclusion criteria
- follicular neoplasm or malignancy findings on biopsy
- nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
- patients with cystic nodules
- patients with contra-lateral vocal cord par- alysis
- previous radiation to the head and neck
- ; follow- up time less than 6 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT06340945 · S2023-761-01