Prospective Observational Study on Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
The goal of this observational study is to assess the impact of endoscopic vacuum therapy in patients who underwent total gastrectomy due to gastric cancer and developed esophago-jejunal anastomotic leakage. The main outcomes to be investigated are the following:
Primary endpoint: mortality rate Secondary endpoints: morbidity rate, time from AL diagnosis to discharge, patients satisfactory rate.
详细描述
Patients who are diagnosed with asophago-jejunal anastomotic leakage will undergo endoscopic vacuum therapy. Local source control may be additionally achieved with para-anastomotic drains.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients who developed esophago-jejunal anastomotic leak less than 50% of circumference of anastomosis
- •patients who developed esophago-jejunal anastomotic leak and remained stable at the moment of diagnosis with no indications for diversion surgery
排除标准
- •unstable patients who developed esophago-jejunal anastomotic leak
- •patients who developed esophago-jejunal anastomotic leak more than 50% or anastomotic circumference
- •patients who rejected endoscopic vacuum therapy
结局指标
主要结局
Mortality rate
时间窗: 90 days after last endo-vac placement
Mortality rate associated with endoscopic vacuum therapy
次要结局
- Morbidity rate(90 days after last endoscopic vacuum placement)
- Time from AL diagnosis to discharge(The number of days from from AL diagnosis to discharge)
- Patients satisfactory rate(90 days after discharge, 365 days after discharge, 2/3/4/5 years after discharge)
研究者
Oleksii Dobrzhanskiy
Surgical oncoligist
Ukrainian Society of Clinical Oncology