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Starting soon Observational

Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

NCT06607133 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Observational
Started
2024-09-10
Last updated
2024-09-23

Condition(s) studied

Benign Thyroid Nodules

Investigational drug(s) / intervention(s)

surgerystaged thermal ablation

surgery: patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules

staged thermal ablation: patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

Study summary

To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group; * the largest diameter of the nodule ≥4 cm; * the presence of nodule-related symptoms, cosmetic concerns, or psychological stress; * patients treated with surgery, or staged thermal ablation (who explicitly refused surgery); * more than 12-month follow-up duration Exclusion Criteria: * suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins); * comorbidities of other severe diseases; * without complete treatment and/or follow-up information

Primary outcome measure(s)

  • volume reduction ratio — From enrollment to the end of treatment at 12 months
    The volume reduction ratio(VRR) = \[(preoperative volume - volume at the follow-up point)/preoperative volume\] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).
  • Complications — From enrollment to the end of treatment at 12 months
    Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06607133 on ClinicalTrials.gov ↗ ← All trials in Japan