A Prospective Multicenter Study to Compare the Therapeutic Outcomes of Microwave Ablation With Surgical Resection for Micropapillary Thyroid Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 973
- Locations
- 1
- Primary Endpoint
- lymph node metastasis
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
surgical resection
thyroid lobectomy, total thyroidectomy, central lymph node dissection
Intervention: Surgical resection (Procedure)
microwave ablation
ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.
Intervention: Microwave ablation (Procedure)
Outcomes
Primary Outcomes
lymph node metastasis
Time Frame: 2-year
the number of patients with lymph node metastasis
Disease progression
Time Frame: 2-year
the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
local tumor progression
Time Frame: 2-year
the number of patients with tumor progression around the treated area
distant metastasis
Time Frame: 2-year
the number of patients with thyroid cancer metastasizing to distant tissues or organs
New thyroid cancer
Time Frame: 2-year
the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland
Secondary Outcomes
- free thyroxine(2-year)
- free triiodothyronine(2-year)
- thyroid-stimulating hormone(2-year)
- complication rate(2-year)
- blood loss(2-year)
Investigators
Ping Liang
Professor
Chinese PLA General Hospital