Thyroid Nodule
Conditions
Brief summary
To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Detailed description
To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Interventions
PROCEDUREultrasound-guided thermal ablation
microwave ablation, radio frequency ablation, laser ablation
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test 2. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT 3. refusal or ineligibility for surgery 4. follow-up time ≥12 months
Exclusion criteria
1. follicular neoplasm or malignancy findings on biopsy 2. no suspicious of malignancy in US 3. patients with contra-lateral vocal cord paralysis 4. follow- up time less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| volume reduction rate | through study completion, an average of 6 months | The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of nodule regrowth | through study completion, an average of 6 months | Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up |
| rate of change of thyroid function | through study completion, an average of 6 months | thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies |
| rate of delayed surgery | through study completion, an average of 1 year | patients underwent surgery after ablation because of anxiety or unsatisfactory about the volume reduction |
| rate of complications | 1 week | complications of ablation |
| symptom score | through study completion, an average of 6 months | The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10) |
| rate of disappearance | through study completion, an average of 6 months | complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound |
| cosmetic score | through study completion, an average of 6 months | The cosmetic score was assessed by a physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem) |
Countries
China
Contacts
Primary ContactLin Yan
Outcome results
None listed