Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules
ConditionThyroid Nodule
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
refusal or ineligibility for surgery
follow-up time ≥12 months
Disqualifiers
follicular neoplasm or malignancy findings on biopsy
no suspicious of malignancy in US
patients with contra-lateral vocal cord paralysis
follow- up time less than 12 months
Trial population
patients with Bethesda III/IV thyroid nodules
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ultrasound-guided thermal ablation
Procedure/Surgerymicrowave ablation, radio frequency ablation, laser ablation
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: ultrasound-guided thermal ablation1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
rate of complications
complications of ablation
Time frame
1 week2
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 months3
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 months4
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 yearSponsors and contacts
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Source ClinicalTrials.gov