跳至主要内容
临床试验/NCT04197960
NCT04197960已完成不适用

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

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 973 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
973
试验地点
1
主要终点
lymph node metastasis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

surgical resection

Active Comparator

thyroid lobectomy, total thyroidectomy, central lymph node dissection

干预措施: Surgical resection (Procedure)

microwave ablation

Experimental

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

干预措施: Microwave ablation (Procedure)

结局指标

主要结局

lymph node metastasis

时间窗: 2-year

the number of patients with lymph node metastasis

Disease progression

时间窗: 2-year

the number of patients with local tumor progression, lymph node metastasis, new cancers or lymph node metastasis.

local tumor progression

时间窗: 2-year

the number of patients with tumor progression around the treated area

distant metastasis

时间窗: 2-year

the number of patients with thyroid cancer metastasizing to distant tissues or organs

New thyroid cancer

时间窗: 2-year

the number of patients with new recurrent malignant thyroid tumor in other area of thyroid gland

次要结局

  • free thyroxine(2-year)
  • free triiodothyronine(2-year)
  • thyroid-stimulating hormone(2-year)
  • complication rate(2-year)
  • blood loss(2-year)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping Liang

Professor

Chinese PLA General Hospital

研究点 (1)

Loading locations...

相似试验