Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules

Recruiting

• Conditions: Thyroid Nodule

• Registration Number: NCT06733753
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Study Timeline

• Study First Submitted: 2024-12-07
• Study Start: 2024-12-09
• Study First Submitted QC: 2024-12-12
• Study First Posted: 2024-12-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
2. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
3. refusal or ineligibility for surgery
4. follow-up time ≥12 months

Exclusion Criteria

1. follicular neoplasm or malignancy findings on biopsy
2. no suspicious of malignancy in US
3. patients with contra-lateral vocal cord paralysis
4. follow- up time less than 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
rate of complications	1 week	complications of ablation
rate of nodule regrowth	through study completion, an average of 6 months	Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up
rate of delayed surgery	through study completion, an average of 1 year	patients underwent surgery after ablation because of anxiety or unsatisfactory about the volume reduction
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)
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)
rate of disappearance	through study completion, an average of 6 months	complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound
rate of change of thyroid function	through study completion, an average of 6 months	thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China