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NCT Number: NCT06729762

Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Lin Yan

CONTACT

Lin Yan

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • follow-up time ≥12 months

Exclusion criteria

  • 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
  • follow- up time less than 12 months

Treatment and study plan

ultrasound-guided thermal ablation

Procedure

radiofrequency ablation, microwave 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 after ablation

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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, MD

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 the Treatment of Benign Thyroid Nodules: A Multicenter Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Dec 11, 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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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