The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Thyroid Nodules

Treatments: Procedure: ultrasound-guided thermal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT06340945

S2023-761-01

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
3. patients with cystic nodules
4. patients with contra-lateral vocal cord par- alysis
5. previous radiation to the head and neck
6. ; follow- up time less than 6 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

ultrasound-guided thermal ablation

Experimental group

Treatment:

Procedure: ultrasound-guided thermal ablation