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NCT Number: NCT06733753

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

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

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Key information

Conditions

Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital, Beijing, Beijing Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ultrasound-guided thermal ablation

Procedure

microwave ablation, radio frequency ablation, laser ablation

Primary outcomes

  1. volume reduction rate

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

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

Secondary outcomes

  1. rate of complications

    Time frame: 1 week

    complications of ablation

  2. rate of nodule regrowth

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

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

  3. rate of change of thyroid function

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

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

  4. rate of delayed surgery

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

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

  5. cosmetic score

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

    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)

  6. symptom score

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

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

  7. rate of disappearance

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Yan

CONTACT

[email protected]

13811237313 ext. 86

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Dec 13, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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