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临床试验/NCT01144325
NCT01144325Unknown2 期

Minimally Invasive Esophagectomy in Prone or Left Decubitus Position: A Prospective Randomized Clinical Trial From A Single Institution

Fudan University1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
2 期
入组人数
2
试验地点
1
主要终点
Perioperative morbidity and mortality from the two groups

研究概览

简要总结

The purpose of this prospective randomized study is to compare clinical outcomes from two different patient position(prone vs left decubitus)with thoracoscopic esophageal mobilization in the procedure of Minimally Invasive Esophagectomy (MIE).

  • Comparing morbidities from the two groups
  • Comparing short-term quality of life from the two groups
  • Comparing oncological results (3,5 year survival) from the two groups

详细描述

Thoracoscopic esophagectomy is routinely performed in two positions. The left decubitus position is the most commonly used position at most centers. However prone position is another alternative.

The left decubitus position is advocated for its the same position as the open procedure and easy to learn, as well as easy to emergent conversion to open thoracotomy .However, the disadvantage of this position is the need of lung retraction for better exposure and definitely one lung ventilation. They are regarded as potential causes leading lung injury.

Prone thoracoscopic esophageal mobilization has been advocated for its potential benefits of increased operative exposure, no lung retraction, avoid one lung ventilation, improved surgeon ergonomics. But it is difficult to make emergent conversion under this positon and not familiar with most thoracic or digestive surgeons. A longer learning curve may be needed.

A few publications have compared the two position with thoracoscopic mobilization of the esophagus in retrospective study of a small cohort. Until now, no prospective randomized study has been carried out in this field.

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
Single (Investigator)

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical stage I/II esophageal cancer
  • normal blood test of basic metabolism panel
  • pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
  • heart function: NY grade I and grade II
  • sign informed consent

排除标准

  • Patients who received neoadjuvant therapy
  • Mental disorders

结局指标

主要结局

Perioperative morbidity and mortality from the two groups

时间窗: 1 -5 years after surgery

次要结局

  • short-term quality of life(postoperative 6 months and 1 year) between the two groups(1 year)
  • 3-and 5-year survival rate between the two groups(1 - 5 years after surgery)

研究者

申办方类型
Other

研究点 (1)

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