The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules
ConditionThyroid Nodules
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
[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
Disqualifiers
follicular neoplasm or malignancy findings on biopsy
nodules with benign result on biopsy had suspicious of malignancy in US, including marked hypoechoic, ill-defined margins, taller-than-wide shape or microcalcifications
patients with cystic nodules
patients with contra-lateral vocal cord par- alysis
Trial design
Design model
Sequential
Treatments tested in this trial
ultrasound-guided thermal ablation
Procedure/Surgerymicrowave ablation, radio frequency ablation, laser ablation
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: ultrasound-guided thermal ablationExperimental treatment 1 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 months2
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 1 monthsSecondary outcomes
1
rate of complications
complications after ablation
Time frame
1 week2
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 months3
symptom score
The symptom score was self-measured by patients using a 10-cm visual analogue scale (grade 0-10)
Time frame
through study completion, an average of 6 months4
vital volume
vital volume was the incompletely treated vital volume which located peripherally
Time frame
through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov