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

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: Papillary Thyroid Cancer

Treatments: Procedure: ultrasound-guided thermal ablation; Procedure: thyroid surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06316895

S2023-706

Details and patient eligibility

About

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;

Enrollment: 3,772 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,772 participants in 2 patient groups

surgery group

Description:

patients with low-risk papillary thyroid carcinoma who chose thyroid surgery

Treatment:

Procedure: thyroid surgery

ablation group

Description:

patients with low-risk papillary thyroid carcinoma who chose thermal ablation

Treatment:

Procedure: ultrasound-guided thermal ablation