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NCT Number: NCT04197960

Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

The study aimed to compare the efficacy and safety of papillary thyroid microcarcinoma (PTMC) treated with microwave ablation(MWA) and surgery resection (SR), and to explore the tumor characteristics suitable for each treatment methods (such as with and without capsular invasion). The investigators organized 18 hospitals to participate in this multicenter study. Patients meeting following indications will be included in this study: 1. Biopsy pathology proved PTMC, but not high-risk subtype; 2. solitary mPTC, without US-detected gross extrathyroid extension; 3. no evidence of metastasis; 4 willing to participate in this study and perform regular follow-up. Patients themselves decide to receive MWA or SR for mPTC after medical consultation. Baseline characteristic including age, gender, thyroid function et al. will be collected. The treatment protocols of MWA and SR were according to the Chinese and international guidelines. The primary outcomes were the disease progression, including local tumor recurrence, lymph node metastasis, and distant metastasis. The secondary outcomes include thyroid function, complication rate, blood loss et al. Investigators will follow up enrolled patients and collect and upload data according to the trial. Treatment outcomes of tumor with and without US-detected capsular invasion was analyzes as subgroups.

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Key information

Conditions

Papillary Thyroid Carcinoma 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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

The treatment protocols of MWA and SR were according to the Chinese and international guidelines. MWA need to ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule. SR basic protocol is lobectomy. All patients need to receive levothyroxine therapy to keep TSH lower than 0.5 mU/L. Patients in both groups underwent regular medical imaging and laboratory tests 1 month, 3-month, 6-month, 12-month, 18-month, 24-month and 36-month after treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Biopsy pathology proved micropapillary thyroid carcinoma(mPTC), but not high-risk subtype
  • Solitary mPTC, without US-detected gross extrathyroid extension
  • No evidence of metastasis
  • Willing to participate in this study and perform regular follow-up

Exclusion criteria

  • Severe blood coagulation dysfunction (platelet count < 50x109/L cells or INR>1.5)
  • Acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
  • Poor control of blood pressure(systolic pressure≥150mmHg or diastolic pressure≥95mmHg)
  • Poor control of blood glucose(fasting glucose>10mmol/L)
  • The opposite vocal cords dysfunction
  • Diagnosed with other malignant tumors
  • Pregnant and lactating women
  • Other conditions that investigator believe are not appropriate to be enrolled

Treatment and study plan

Microwave ablation

Procedure

Use thermal energy to destroy tumor

Surgical resection

Procedure

Resect tumors

Primary outcomes

  1. local tumor progression

    Time frame: 2-year

    the number of patients with tumor progression around the treated area

  2. lymph node metastasis

    Time frame: 2-year

    the number of patients with lymph node metastasis

  3. distant metastasis

    Time frame: 2-year

    the number of patients with thyroid cancer metastasizing to distant tissues or organs

  4. New thyroid cancer

    Time frame: 2-year

    the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland

  5. Disease progression

    Time frame: 2-year

    the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.

Secondary outcomes

  1. complication rate

    Time frame: 2-year

    complication rate encouned during or after procedures

  2. blood loss

    Time frame: 2-year

    the volume of blood loss during procedures

  3. free thyroxine

    Time frame: 2-year

    change of free thyroxine concentration

  4. free triiodothyronine

    Time frame: 2-year

    change of free triiodothyronine concentration

  5. thyroid-stimulating hormone

    Time frame: 2-year

    change of thyroid-stimulating hormone concentration

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 13, 2019
Registry last updated
Aug 5, 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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