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

Not Applicable

Recruiting

• Conditions: Thyroid Nodules

• Registration Number: NCT06340945
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-31
• Study Start: 2024-04-01
• Study First Posted: 2024-04-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-10
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
rate of nodule regrowth	through study completion, an average of 1 months	Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up
volume reduction rate	through study completion, an average of 6 months	The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume

Secondary Outcome Measures

Name	Time	Method
vital volume	through study completion, an average of 6 months	vital volume was the incompletely treated vital volume which located peripherally
rate of complications	1 week	complications after ablation
symptom score	through study completion, an average of 6 months	The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)
total volume	through study completion, an average of 6 months	the overall volume of the nodules
cosmetic score	through study completion, an average of 6 months	The cosmetic score was assessed by a physician (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)

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China