Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules

Chinese PLA General Hospital600 enrolled

Overview

To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Thyroid Nodule

Interventions

ultrasound-guided thermal ablationPROCEDURE

microwave ablation, radio frequency ablation, laser ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Chinese PLA General Hospital

Beijing, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

volume reduction rate

The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume

Time frame: through study completion, an average of 6 months

Secondary Outcomes

rate of complications

complications of ablation

Time frame: 1 week

rate of nodule regrowth

Regrowth was defined as ≥50% volume increase compared to the previously recorded smallest volume during the follow-up

Time frame: through study completion, an average of 6 months

rate of change of thyroid function

thyroid function test, including free triiodothyronine, free thyroxine, thyroid stimulating hormone, thyroid peroxidase antibody and anti-thyroglobulin antibodies

Time frame: through study completion, an average of 6 months

rate of delayed surgery

patients underwent surgery after ablation because of anxiety or unsatisfactory about the volume reduction

Time frame: through study completion, an average of 1 year

cosmetic score

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)

Time frame: through study completion, an average of 6 months

symptom score

The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)

Central Contacts

Lin Yan

CONTACT

13811237313 gemma-y@163.com

Data from ClinicalTrials.gov

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