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A randomized control trial of contrast enhanced ultrasound-versus conventional ultrasound-guided fine-needle aspiration biopsy of thyroid nodules

A randomized control trial of contrast enhanced ultrasound-versus conventional ultrasound-guided fine-needle aspiration biopsy of thyroid nodules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062893
Enrollment
Unknown
Registered
2022-08-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodules

Interventions

CEUS-FNA:contrast enhanced ultrasound guided
US-FNA:conventional ultrasound guided

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Thyroid nodule confirmed by ultrasound; 3. Nodule meets the FNA criteria recommended by the C-TIRADS guidelines; 4. Nodule meets one of the following criteria for high risk of inadequacy: (1) Nodule with high cystic component: cystic (solid portion = 3 mm marcocalcification, visible solid protion = 95%) or predominantly solid (50% <= solid portion < 95%), hypoechoic or very-hypoechoic, avascular, hypoechoic halo, with or without macrocalcification; (4) Suspicious PTC with severe fibrosis: very-hypoechoic, posterior echogenic attenuation or acoustic shadowing, avascular; 5. The informed consent form has been signed.

Exclusion criteria

Exclusion criteria: 1. Allergic to lidocaine or SonoVue; 2. Refusal to CEUS; 3. Severe cardiac and pulmonary abnormalities; 4. Severe coagulation abnormalities; 5. Pregnancy; 6. Active infected lesions on the skin of the neck; 7. Physical and psychological barriers to cooperation with FNA or CEUS: psychiatric disorders, excessive obesity, post-tracheotomy.

Design outcomes

Primary

MeasureTime frame
FNA specimen inadequate rate;

Secondary

MeasureTime frame
immediate complication rate;operative time;

Countries

China

Contacts

Public ContactTinghui Yin

The Third Affiliated Hospital of Sun Yat-sen University

yinth3@mail.sysu.edu.cn+86 13828490603

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026