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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
973
Use thermal energy to destroy tumor
Resect tumors
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
local tumor progression
the number of patients with tumor progression around the treated area
Time frame: 2-year
lymph node metastasis
the number of patients with lymph node metastasis
Time frame: 2-year
distant metastasis
the number of patients with thyroid cancer metastasizing to distant tissues or organs
Time frame: 2-year
New thyroid cancer
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Time frame: 2-year
Disease progression
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
Time frame: 2-year
complication rate
complication rate encouned during or after procedures
Time frame: 2-year
blood loss
the volume of blood loss during procedures
Time frame: 2-year
free thyroxine
change of free thyroxine concentration
Time frame: 2-year
free triiodothyronine
change of free triiodothyronine concentration
Time frame: 2-year
thyroid-stimulating hormone
change of thyroid-stimulating hormone concentration
Time frame: 2-year
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