Thyroid Nodules
Conditions
Brief summary
1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules; 2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules
Interventions
PROCEDUREultrasound-guided thermal ablation
microwave ablation, radio frequency ablation, laser ablation
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \[1\]confirmation of benign nodule status on two separate fine- needle aspiration (FNA) or core-needle biopsy (CNB) \[2\]no suspicious malignant features on ultrasound examination \[3\]report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation \[4\]refusal or ineligibility for surgery \[5\]follow-up time ≥6months
Exclusion criteria
1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications 3. patients with cystic nodules 4. patients with contra-lateral vocal cord par- alysis 5. previous radiation to the head and neck 6. ; follow- up time less than 6 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 |
| rate of nodule regrowth | through study completion, an average of 1 months | Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of complications | 1 week | complications after ablation |
| 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) |
| 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) |
| vital volume | through study completion, an average of 6 months | vital volume was the incompletely treated vital volume which located peripherally |
| total volume | through study completion, an average of 6 months | the overall volume of the nodules |
Countries
China
Contacts
CONTACTLin Yan, MD.
Outcome results
None listed