A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Pulmonary function
研究概览
简要总结
A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.
详细描述
The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.
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 (Participant)
入排标准
- 年龄范围
- 55 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thoracic esophageal squamous cell carcinoma
排除标准
- •Preoperative chemoradiotherapy
- •Cardiovascular disease with NYHA grade III or IV
- •Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo
- •Liver cirrhosis
- •Renal failure
研究组 & 干预措施
Control group
Patients in the control group received saline for 7 days starting at the beginning of surgery
干预措施: sivelestat sodium hydrate (Drug)
S group
Patients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery
干预措施: sivelestat sodium hydrate (Drug)
结局指标
主要结局
Pulmonary function
时间窗: 9 days
the arterial oxygen pressure
次要结局
- Pulmonary function(9 days)