Endoscopic Evaluation for the Postoperative Condition After Esophagectomy and Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
研究概览
简要总结
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
详细描述
Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. However the evaluation and prevention before developing gastric conduit ischemia have been established. The investigators have built a hypothesis that the evaluation for gastric mucosal ischemia in early phase after esophagectomy predict the complication of gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.
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
- 20 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant or end-stage benign esophageal disease.
- •Esophagectomy with reconstruction by a gastric pull-up.
排除标准
- •Severe heart failure and pulmonary dysfunction
- •Severe renal and liver dysfunction
- •Allergenic history
- •Pregnancy
结局指标
主要结局
Number of participants with endoscopy-related adverse events as assessed by Clavien-Dindo Classification
时间窗: From 1 to 29 days after esophagectomy
Number of participants with the classification of gastric conduit ischemia by endoscopic findings
时间窗: From 1 to 15 days after esophagectomy
Number of participants with the major complications of gastric conduit (strictures, leakage, necrosis)
时间窗: From 1 to 29 days after esophagectomy
次要结局
- Biological examination of the mucosal biopsy of gastric conduit as assessed by the scoring system for immunohistochemical staining(From 1 to 29 days after esophagectomy)
- Biological examination of the mucosal biopsy of gastric conduit as assessed by the ischemia related RNA copy number(From 1 to 29 days after esophagectomy)
- Biological examination of gastric conduit as assessed by the Mitochondrial DNA copy number(From 1 to 29 days after esophagectomy)
研究者
Kobayashi Shinichiro
Assistant professor
Nagasaki University