The Clinical Outcomes of Ultrasound-guided Thermal Ablation for the Treatment of Papillary Thyroid Carcinoma: A Multicenter Study

Chinese PLA General Hospital1 site in 1 country3,000 target enrollmentDecember 10, 2024

ConditionsPapillary Thyroid Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Papillary Thyroid Cancer
Sponsor: Chinese PLA General Hospital
Enrollment: 3000
Locations: 1
Primary Endpoint: rate of disease progression
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

Detailed Description

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Registry

clinicaltrials.gov

Start Date

December 10, 2024

End Date

December 31, 2030

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Chinese PLA General Hospital

Responsible Party

Principal Investigator

Yu-kun Luo

Clinical Professor

Chinese PLA General Hospital

Eligibility Criteria

Inclusion Criteria

•patients age between 18 and 80 year old, both sex
•papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
•the largest diameter ≤2.0 cm
•no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
•follow-up period ≥12 months

Exclusion Criteria

•patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
•history of neck radiation
•coagulation disorder, serious heart, respiratory, liver, or renal failure
•dysfunction of the vocal cord on the opposite side

Outcomes

Primary Outcomes

rate of disease progression

Time Frame: through study completion, an average of 6 months

cervical lymph node metastases, recurrent tumors and persistent tumors confirmed by pathology

Secondary Outcomes

Rate of complications(1 week)
rate of delayed surgery(through study completion, an average of 1 year)
Rate of tumor disappearance(through study completion, an average of 6 months)
Rate of volume reduction(through study completion, an average of 6 months)
rate of change of thyroid function(through study completion, an average of 6 months)