The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

Recruiting

• Conditions: Papillary Thyroid Cancer
• Interventions: Procedure: thyroid surgery; Procedure: ultrasound-guided thermal ablation

• Registration Number: NCT06316895
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;

2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-03-16
• Study First Posted: 2024-03-19
• Study Start: 2024-04-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-04-01
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3772

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, nech 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. history of thyroid surgery
4. coagulation disorder
5. serious heart, respiratory, liver, or renal failure
6. dysfunction of the vocal cord on the opposite side

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery group	thyroid surgery	patients with low-risk papillary thyroid carcinoma who chose thyroid surgery
ablation group	ultrasound-guided thermal ablation	patients with low-risk papillary thyroid carcinoma who chose thermal ablation

Primary Outcome Measures

Name	Time	Method
rate of disease progression	more than 5 year	cervical lymph node metastases, recurrent tumors and persistent tumors

Secondary Outcome Measures

Name	Time	Method
Rate of tumor disappearance	2 year	complete disappearance of ablated tumor on ultrasound and contrast-enhanced ultrasound
Rate of complications	1week	surgery or ablation complications

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China