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

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.

Study Overview

• Status: Completed
• Conditions: Papillary Thyroid Carcinoma
• Intervention / Treatment: Procedure: Microwave ablation; Procedure: Surgical resection

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 Type: Interventional
• Enrollment (Actual): 973
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: microwave ablation; ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.	Procedure: Microwave ablation; Use thermal energy to destroy tumor
Active Comparator: surgical resection; thyroid lobectomy, total thyroidectomy, central lymph node dissection	Procedure: Surgical resection; Resect tumors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local tumor progression	the number of patients with tumor progression around the treated area	2-year
lymph node metastasis	the number of patients with lymph node metastasis	2-year
distant metastasis	the number of patients with thyroid cancer metastasizing to distant tissues or organs	2-year
New thyroid cancer	the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland	2-year
Disease progression	the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate	complication rate encouned during or after procedures	2-year
blood loss	the volume of blood loss during procedures	2-year
free thyroxine	change of free thyroxine concentration	2-year
free triiodothyronine	change of free triiodothyronine concentration	2-year
thyroid-stimulating hormone	change of thyroid-stimulating hormone concentration	2-year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Ping Liang, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Surgical resection; Microwave ablation; Papillary Thyroid Carcinoma
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Adenocarcinoma, Papillary; Thyroid Cancer, Papillary; Thyroid Diseases; Carcinoma; Thyroid Neoplasms
• Other Study ID Numbers: 301jrcsk-lp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No