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NCT Number: NCT07776262

Safety and Efficacy of Cryoablation for Thyroid Tumors

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Yukun Luo, MD

CONTACT

[email protected]

+86 010-6693 9533

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

【Group 1: Papillary Thyroid Carcinoma (PTC) patients】

  • Pre-operative ultrasound evaluation shows the maximum tumor diameter <1 cm;
  • Papillary thyroid carcinoma (PTC) confirmed by ultrasound-guided fine-needle aspiration (FNA) biopsy;
  • Solitary PTC confirmed by pre-operative ultrasound;
  • Imaging examinations demonstrate no extrathyroidal invasion, cervical lymph node metastasis or distant metastasis.

【Group 2: Benign thyroid nodule patients】

  • Benign nodule confirmed by puncture biopsy;
  • Preoperative ultrasound confirms solid nodule with maximum diameter greater than 2 cm;
  • 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】
  • Patients with uncorrected psychiatric disorders or consciousness disturbance who cannot cooperate with treatment;
  • Patients with neck extension disorders of various causes who cannot cooperate with treatment;
  • Severe coagulation dysfunction, or patients taking oral anticoagulants who have not completed the required drug withdrawal period;
  • Severe cardiopulmonary insufficiency and inability to lie supine for the procedure;
  • Unrecovered recurrent laryngeal nerve injury contralateral to the lesion.

Treatment and study plan

Ultrasound-guided percutaneous cryoablation of thyroid neoplasm

Procedure

Under local anesthesia, ultrasound-guided percutaneous cryoablation is applied to treat thyroid neoplasms. Targeted tumor tissue is destroyed by ultralow temperature from cryoprobes.

Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm

Procedure

Ultrasound-guided percutaneous microwave ablation of thyroid neoplasm

Primary outcomes

  1. Tumor Volume Reduction Rate (VRR) at 12 months after ablation

    Time frame: 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 outcomes

  1. Complete tumor disappearance rate at 12 months

    Time frame: 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.

  2. Incidence of treatment-related complications

    Time frame: 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.

  3. Postoperative pain visual analog scale (VAS) score

    Time frame: 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.

  4. Total operation time

    Time frame: Intraoperative period only

    Total procedure duration from puncture to completion of ablation under ultrasound guidance for each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Yukun Luo, MD

CONTACT

[email protected]

010-66939533

Sponsors and collaborators

Lead sponsor

Yukun Luo

Other

Registry information

Official study title

Study on the Safety and Efficacy of Cryoablation Therapy for Thyroid Tumors

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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