Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma

Recruiting

• Conditions: Papillary Thyroid Cancer

• Registration Number: NCT06733740
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

Detailed Description

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Study Timeline

• Study First Submitted: 2024-12-06
• Study Start: 2024-12-10
• 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: 3000

Inclusion Criteria

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
5. follow-up period ≥12 months

Exclusion Criteria

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. coagulation disorder, serious heart, respiratory, liver, or renal failure
4. dysfunction of the vocal cord on the opposite side

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of disease progression	through study completion, an average of 6 months	cervical lymph node metastases, recurrent tumors and persistent tumors confirmed by pathology

Secondary Outcome Measures

Name	Time	Method
Rate of complications	1 week	complications of ablation
rate of delayed surgery	through study completion, an average of 1 year	patients underwent surgery after ablation because of anxiety
Rate of tumor disappearance	through study completion, an average of 6 months	complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
Rate of volume reduction	through study completion, an average of 6 months	volume reduction of tumor after ablation 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, Beijing, China