Thyroid Nodule (Benign)
Conditions
Brief summary
To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules
Detailed description
To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study
Interventions
PROCEDUREultrasound-guided thermal ablation
radiofrequency ablation, microwave 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 benign nodule status on two separate fine- needle aspiration or core-needle biopsy 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 ≥12 months
Exclusion criteria
1. follicular neoplasm or malignancy findings on biopsy 2. nodules with benign result on biopsy had suspicious of malignancy in US 3. patients with contra-lateral vocal cord paralysis 4. previous radiation to the head and neck 5. 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 |
|---|---|---|
| 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) |
| rate of complications | 1 week | complications after ablation |
| 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 disappearance | through study completion, an average of 6 months | complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound |
| 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 |
Countries
China
Contacts
Primary ContactLin Yan, MD
Outcome results
None listed