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临床试验/NCT00650559
NCT00650559终止不适用

Chest Wall Enlargement by Widening Sternotomy in Patients With Severe Emphysema: a Feasibility Trial.

KU Leuven2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
KU Leuven
入组人数
4
试验地点
2
主要终点
Improvement of FEV1

研究概览

简要总结

There is a growing population of end-stage COPD patients for whom surgical treatments like lung transplantation and lung volume reduction surgery are not possible. In such patients, size mismatch between large emphysematous lungs and a restricted chest wall is a major cause for the reduction of dynamic lung volumes and consequent dyspnea. We hypothesized that enlargement of the thorax would be a potential alternative strategy to volume reduction surgery as it may improve lung mechanics by resizing the chest to the lung and does not further deprive patients from lung tissue which is already scarce.

详细描述

Lung volume reduction surgery primarily increases vital capacity by reducing RV more than TLC. As the chest wall is the major TLC limiting factor, an alternative approach that could circumvent size mismatch would be a surgical enlargement of the thorax cavity. Any post-operative increase of TLC would allow greater dynamic operational lung volumes to occur with an equal amount of dead space. Moreover, resizing of the thorax would have a tremendous advantage over resizing of the lung, in that it would not require resection of the lung in patients in whom lung tissue is already scarce. Chest expansion will only be guaranteed if the sternal widening osteotomy will obtain a solid union. Small poly-ether-ether-keton (PEEK) cages were designed to match both sternal halves in a 'press fit' way, which were filled with lyophilised bone and fixed with extra wires as in a classical sternotomy. These bone-filled cages function as a perfect matrix for progressive in-growth of cancellous bone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • patients with end-stage emphysema and
  • Disabling dyspnea
  • GOLD III or IV
  • Residual volume > 200% predicted
  • Total Lung capacity > 120% predicted
  • RV/TLC > 0.6
  • Resting CO2 < 50 mmHg
  • diffusion capacity > 20% predicted
  • age < 70 years

排除标准

  • previous sternotomy
  • contraindication of general anesthesia
  • chronic treatment with corticosteroids
  • any tobacco use within 6 months
  • candidates for lung volume reduction surgery or lung transplantation

结局指标

主要结局

Improvement of FEV1

时间窗: 1 year

次要结局

  • Improvement of exercise capacity(1 year)

研究者

发起方
KU Leuven
申办方类型
Other

研究点 (2)

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