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The outcomes of active survelliance vs. ultrasound-guided microwave ablation of papillary thyroid microcarcinoma: a non-randomized concurrent controlled study

The outcomes of active survelliance vs. ultrasound-guided microwave ablation of papillary thyroid microcarcinoma: a non-randomized concurrent controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079260
Enrollment
Unknown
Registered
2023-12-28
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Thyroid papillary microcarcinoma

Interventions

Active surveillance group:Patients observed with active surveillance, TSH suppression is given when it is necessary.
Microwave ablation group:Patients without TSH suppression after microwave ablation

Sponsors

Jiangsu Institute of Nuclear Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients volunteered to participate in the study and sign an informed consent form; 2. Age range from 18 to 70 years old (including 18 and 70 years old), ensuring that the expected follow-up period is greater than 5 years; 3. Fine needle aspiration cytological result is malignant or suspicious for malignancy (Bethesda V or VI), or histological diagnosis of core needle biopsy is papillary thyroid cancer; 4. The nodules with cytological result of Bethesda V should have highly suspicious features of ACR TIRADS; 5. The maximum diameter of the nodule is = 10mm; 6. The patients refuse surgical resection.

Exclusion criteria

Exclusion criteria: 1. Inability to understand or disagree with the research proposal; 2. Cytological diagnosis was aggressive variant PTC; 3. The tumor present with extrathyroidal extension; 4. The tumor adhered to the trachea at an obtuse angle and may be invaded; 5. Lymph node metastasis or distant metastasis was confirmed by imaging or cytology; 6. Clinical finding of trachea or recurrent laryngeal nerve invasion; 7. Underwent radiotherapy in the childhood; 8. Pregnancy; 9. Multiple suspicious lesions on imaging; 10. Contralateral vocal cord paralysis or dysfunction; 11. Patients with coagulation dysfunction and serious cardiopulmonary diseases who cannot tolerate treatment; 12. Subjects who are estimated to have insufficient compliance to participate in the clinical study or have other factors that the investigator considers unsuitable for participating in the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Recurrence-free survival;Tumor recurrence rate;Local/distant tumor metastasis rate;Volume reduced rate at 1,3,6,12,24,36,48,60 months after treatment;

Secondary

MeasureTime frame
Time to Progression;Objective Response Rate;SF-36 and THYCA-QoL quality of life questionnaires;

Countries

China

Contacts

Public ContactWu Hongxun

Jiangsu Institute of Nuclear Medicine

whxmd@outlook.com+86 139 1534 8600

Outcome results

None listed

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