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Completed

NCT Number: NCT06325787

Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma

To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Papillary Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • solitary papillary thyroid carcinoma confirmed by fine-needle aspiration or core-needle biopsy;
  • largest diameter ≤10 mm;
  • no evidence of extrathyroidal extension( no signs of unsmooth thyroid capsule or involvement of the perithyroidal tissue) on ultrasound;
  • no evidence of cervical lymph node metastasis on US or neck CT;
  • no distant metastasis on chest CT;
  • no history of neck irradiation.

Exclusion criteria

  • (1)aggressive subtype of papillary thyroid microcarcinoma confirmed by biopsy(1); (2)multiple tumors; (3) incomplete data or lost follow-up

Treatment and study plan

Thyroid lobectomy

Procedure

thyroid lobectomy

image-guided thermal ablation

Procedure

radiofrequency ablation or microwave ablation or laser ablation

Primary outcomes

  1. disease progression

    Time frame: more than 5 years

    cervical lymph node metastases, recurrent tumors and persistent tumors

  2. disease-free survival

    Time frame: more than 5 years

    disease-free survival calculated from treatment initiation to disease progression or the last follow-up date

Secondary outcomes

  1. complications

    Time frame: 1 week

    complications after surgery or ablation

  2. procedure time

    Time frame: 1 hour after treatment

    Ablation procedure time was defined from US evaluation for the design of insertion way to treatment terminated. Lobectomy procedure time was defined from incision to closure, not including the anesthesia time.

  3. cost

    Time frame: 1 week

    The ablation cost included preoperative examinations, treatment, local anesthesia and ablation needle costs. The lobectomy cost included preoperative examinations, treatment, general anesthesia, hospital bed, nursing and postoperative medication

  4. estimated blood loss

    Time frame: 1 hour

    estimated blood loss after surgery or ablation

  5. hospitalization

    Time frame: 1 week

    hospitalization for surgery or ablation

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Long-term Comparison of Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma: A Multicenter Retrospective Study

Important dates

Study start
2013
Primary completion
2017
Study completion
2024
First posted
Mar 22, 2024
Registry last updated
Mar 25, 2024

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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