Microwave Ablation and Surgical Resection for Micropapillary Thyroid Carcinoma

NCT04197960 | Completed DMC

• 1 other identifier: 301jrcsk-lp
• Study Type: interventional
• Target: 973
• Locations: 1 country
• Sites: 1

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.

Conditions

Papillary Thyroid Carcinoma

Keywords

Papillary Thyroid Carcinoma; Microwave ablation; Surgical resection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• complication rate

  2-year

• blood loss

  2-year

• free thyroxine

  2-year

• free triiodothyronine

  2-year

• thyroid-stimulating hormone

  2-year

Study Arms (2)

microwave ablation

EXPERIMENTAL

ablate all tumors including at least 2mm safe margin except for tumors adjacent to thyroid capsule.

Procedure: Microwave ablation

surgical resection

ACTIVE COMPARATOR

thyroid lobectomy, total thyroidectomy, central lymph node dissection

Procedure: Surgical resection

Interventions

Microwave ablation PROCEDURE

Use thermal energy to destroy tumor

microwave ablation

Surgical resection PROCEDURE

Resect tumors

surgical resection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Zheng L, Dou JP, Han ZY, Liu FY, Yu J, Cheng ZG, Yu XL, Wang H, Cong ZB, Wang SR, Yu MA, Xu ZF, Che Y, Nan B, Liu C, Hao Y, Wang X, Liu Y, Zhou Y, Liang P. Microwave Ablation for Papillary Thyroid Microcarcinoma with and without US-detected Capsule Invasion: A Multicenter Prospective Cohort Study. Radiology. 2023 May;307(3):e220661. doi: 10.1148/radiol.220661. Epub 2023 Mar 7.

  PMID: 36880949 DERIVED

MeSH Terms

Conditions

Thyroid Cancer, Papillary

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Ping Liang

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: December 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)