Thyroid Neoplasm, Thyroid Tumor
Conditions
Brief summary
The goal of this clinical study is to learn if cryoablation works to treat thyroid tumors. It will also learn about the safety of cryoablation for thyroid tumors. The main questions it aims to answer are: * Does cryoablation shrink thyroid tumors over time? * What side effects or problems do participants have after cryoablation? Participants will receive cryoablation treatment guided by ultrasound. Researchers will track tumor size changes and check for any safety issues during follow-up visits.
Interventions
PROCEDUREUltrasound-guided percutaneous cryoablation of thyroid neoplasm
Under local anesthesia, ultrasound-guided percutaneous cryoablation is applied to treat thyroid neoplasms. Targeted tumor tissue is destroyed by ultralow temperature from cryoprobes.
PROCEDUREUltrasound-guided percutaneous microwave ablation of thyroid neoplasm
Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm
Sponsors
Yukun Luo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
【Group 1: Papillary Thyroid Carcinoma (PTC) patients】 1. Pre-operative ultrasound evaluation shows the maximum tumor diameter \<1 cm; 2. Papillary thyroid carcinoma (PTC) confirmed by ultrasound-guided fine-needle aspiration (FNA) biopsy; 3. Solitary PTC confirmed by pre-operative ultrasound; 4. Imaging examinations demonstrate no extrathyroidal invasion, cervical lymph node metastasis or distant metastasis. 【Group 2: Benign thyroid nodule patients】 1. Benign nodule confirmed by puncture biopsy; 2. Preoperative ultrasound confirms solid nodule with maximum diameter greater than 2 cm; 3. Patients refuse surgical treatment or cannot tolerate surgery, voluntarily receive thyroid ablation therapy and sign the informed consent form.
Exclusion criteria
【Group 1: Papillary Thyroid Carcinoma (PTC) patients】 * (1) Biopsy confirms high-risk subtype papillary thyroid carcinoma; (2) History of thyroid surgery or radiotherapy; (3) Complicated with malignant tumors in other sites; (4) Severe coagulation dysfunction, or patients taking oral anticoagulants who have not reached the required drug-withdrawal period; (5) Incomplete follow-up data. 【Group 2: Benign thyroid nodule patients】 1. Patients with uncorrected psychiatric disorders or consciousness disturbance who cannot cooperate with treatment; 2. Patients with neck extension disorders of various causes who cannot cooperate with treatment; 3. Severe coagulation dysfunction, or patients taking oral anticoagulants who have not completed the required drug withdrawal period; 4. Severe cardiopulmonary insufficiency and inability to lie supine for the procedure; 5. Unrecovered recurrent laryngeal nerve injury contralateral to the lesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Volume Reduction Rate (VRR) at 12 months after ablation | Baseline (pre-ablation), 12 months after ablation | Tumor volume is measured by two-dimensional thyroid ultrasound before treatment and at 12-month follow-up. Volume Reduction Rate (%) = (Baseline tumor volume - 12-month ablation zone volume) / Baseline tumor volume × 100%. Compare VRR between microwave ablation group and cryoablation group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete tumor disappearance rate at 12 months | Baseline, 1, 3, 6, 12 months post-ablation | Complete disappearance is defined as no visible residual lesion and blurred ablation boundary on thyroid ultrasound \& contrast-enhanced ultrasound at 12-month follow-up. Count participants with complete lesion absorption in two groups. |
| Incidence of treatment-related complications | Intraoperative, immediate post-op, 1 day, 1, 3, 6, 12 months after ablation | Complications include transient hoarseness, hemorrhage, infection, nerve injury, thyroid dysfunction, etc. Divided into minor and major complications according to interventional radiology standard; record all adverse events from procedure to 12-month follow-up. |
| Postoperative pain visual analog scale (VAS) score | Immediately after ablation, postoperative day 1 | Pain scored by VAS (0-10 scale, 0=no pain, 10=worst pain imaginable), assessed at immediate post-procedure and postoperative day 1. |
| Total operation time | Intraoperative period only | Total procedure duration from puncture to completion of ablation under ultrasound guidance for each participant. |
Countries
China
Contacts
CONTACTYukun Luo, MD
Outcome results
None listed