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Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04197960
Enrollment
973
Registered
2019-12-13
Start date
2019-12-01
Completion date
2022-12-31
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma, Microwave ablation, Surgical resection

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.

Interventions

PROCEDUREMicrowave ablation

Use thermal energy to destroy tumor

PROCEDURESurgical resection

Resect tumors

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Disease progression2-yearthe number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.
local tumor progression2-yearthe number of patients with tumor progression around the treated area
lymph node metastasis2-yearthe number of patients with lymph node metastasis
distant metastasis2-yearthe number of patients with thyroid cancer metastasizing to distant tissues or organs
New thyroid cancer2-yearthe number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland

Secondary

MeasureTime frameDescription
complication rate2-yearcomplication rate encouned during or after procedures
blood loss2-yearthe volume of blood loss during procedures
free thyroxine2-yearchange of free thyroxine concentration
free triiodothyronine2-yearchange of free triiodothyronine concentration
thyroid-stimulating hormone2-yearchange of thyroid-stimulating hormone concentration

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026