Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules
ConditionThyroid Nodule (Benign)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
no suspicious malignant features on ultrasound examination
report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
refusal or ineligibility for surgery
Disqualifiers
follicular neoplasm or malignancy findings on biopsy
nodules with benign result on biopsy had suspicious of malignancy in US
patients with contra-lateral vocal cord paralysis
previous radiation to the head and neck
Trial population
patients with thyroid nodules
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ultrasound-guided thermal ablation
Procedure/Surgeryradiofrequency ablation, microwave ablation, laser ablation
Treatment groups
1,500 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 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
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 monthsSponsors and contacts
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Source ClinicalTrials.gov