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临床试验/NCT02317224
NCT02317224招募中2 期

Comparison of Safety and Efficacy Among "3-Hole" Subxiphorid Approach, Trans Sternal Approach and VATS in Surgical Treatment of Anterior Mediastinal Tumor

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Duration of operation

研究概览

简要总结

Surgery plays an important role in the treatment of anterior mediastinum disease. The major surgical approaches include: cervical approach, mid-sternal approach, cervical combined mid-sternal approach and video-assisted thoracoscopic approach. The cervical approach is rarely adopted because of its restricted visual field. The cervical combined mid-sternal approach have a broader field of vision, given this advantage, the surgeon can remove the thymus and its surrounding fat tissue more thoroughly. But the trauma of this approach is much larger, and the postoperative complication is also a serious problem. The video-assisted thoracoscope is often adopted by left or right approach, this minimally invasive procedure can not remove anterior mediastinum fat thoroughly. In clinical practice, the investigators designed a new method named "3-Hole" subxiphoid approach. This study is designed to compare the safety and validity between this new method and others.

研究设计

研究类型
Interventional
分配方式
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

入选标准

  • MG with thymic hyperplasia, thymoma or other anterior mediastinum disease
  • Masaoka stagingⅠ-Ⅱ
  • Thymoma without MG
  • Mass diameter <10cm
  • Inform Consent Form is signed

排除标准

  • Unable to tolerate surgery
  • myasthenic crisis
  • Masaoka staging Ⅲ-Ⅳ
  • Patients who have undergone previous surgery or radiotherapy
  • pregnancy , breastfeeding or younger than 18 years old

结局指标

主要结局

Duration of operation

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Rate of conversions to thoracotomy

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Only in "3-Hole" subxiphorid group and VATS group

Amount of bleeding

时间窗: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Measured by the difference between the wet weight and dry weight of surgical gauze

Mortality rate

时间窗: up to 10 years

Death caused by operation or complications

Overall survival

时间窗: up to 10 years

From randomization to any cause of death

Quality of life

时间窗: up to 10 years after operation

Measured by EORTC QLQ-C30 (version 3) scale

Number of Participants with Adverse Events

时间窗: up to 8weekss afte operation

次要结局

未报告次要终点

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongan Zhou

Associate Professor

Tang-Du Hospital

研究点 (1)

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