Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

Recruiting

• Conditions: Thyroid Nodule (Benign)

• Registration Number: NCT06729762
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

Detailed Description

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study

Study Timeline

• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-07
• Study Start: 2024-12-09
• Study First Posted: 2024-12-11
• 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: 1500

Inclusion Criteria

1. confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
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 ≥12 months

Exclusion Criteria

1. follicular neoplasm or malignancy findings on biopsy
2. nodules with benign result on biopsy had suspicious of malignancy in US
3. patients with contra-lateral vocal cord paralysis
4. previous radiation to the head and neck
5. 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 after ablation
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 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 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
rate of disappearance	through study completion, an average of 6 months	complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China