Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

Chinese PLA General Hospital1,500 enrolled

Overview

To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Thyroid Nodule (Benign)

Interventions

ultrasound-guided thermal ablationPROCEDURE

radiofrequency ablation, microwave ablation, laser ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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 after ablation

Time frame: 1 week

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)

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

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 disappearance

complete disappearance of ablated nodule on ultrasound and contrast-enhanced ultrasound

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

Central Contacts

Lin Yan, MD

CONTACT

13811237313 gemma-y@163.com

Data from ClinicalTrials.gov

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