NCT03251040已完成不适用
Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study
Amsterdam UMC, location VUmc0 个研究点目标入组 15 人开始时间: 2015年8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
- 15
- 主要终点
- Anastomotic leakage
研究概览
简要总结
Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. The investigators aimed to investigate feasibility of additional sealing by means of autologous fibrin sealant of the esophageal anastomosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 90 years
- •Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).
- •physical status (American Society of Anesthesiologists) of 3 or lower
排除标准
- •Other malignancies
- •Previous esophageal surgery were excluded
研究组 & 干预措施
Fibrin sealant
Other
Single arm pilot study
干预措施: Autologous activated fibrin sealant (Device)
结局指标
主要结局
Anastomotic leakage
时间窗: 30-day morbidity
次要结局
未报告次要终点
研究者
Victor Plat
Principal investigator
Amsterdam UMC, location VUmc
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