Quantitative Assessment of the Correlation Between Blood Supply in the Gastic Conduit and the Incidence of Anastomotic Fistula With Fluorescence Angiography for Esophageal Reconstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- The incidence of anastomotic fistula
研究概览
简要总结
A single-institution, randomize controlled trial is to be held to evaluate the correlation between blood supply in the gastic conduit and the incidence of anastomotic fistula during radical operation for esophageal squamous cell carcinoma by fluorescence angiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Histologically confirmed esophageal squamous cell carcinoma and and potential resection;
- •2.Intend to undergo thoracic laparoscopy combined with three-incision esophageal cancer radical operation;
- •3.The stomach is used as an esophageal substitute for reconstruction;
- •4.Enrolled patients will adopt the esophagus bed pathway and round neck anastomosis method;
- •5.Have a performance status of 0 or 1 on the ECOG Performance Scale; Adequate organ function;
- •6.Be willing and able to provide written informed consent/assent for the trial.
排除标准
- •1.Histologically confirmed non-squamous cell carcinoma of the esophagus ;
- •2.The ECOG score of patient's physics >1;
- •3.Patients who use other organs instead of the esophagus;
- •4.Patients with vascular arch injury and need vascular anastomosis;
- •5.Patients with multiple complications such as heart disease or diabetes;
- •6.Other patients whom the medical practitioner considers inappropriate for inclusion.
结局指标
主要结局
The incidence of anastomotic fistula
时间窗: 3 months
Anastomotic fistula is defined as an anastomotic fistula or any anastomotic dehiscence or leakage of saliva from a neck wound, confirmed by gastroscopy or upper gastrointestinal angiography, or purulent discharge from the chest or mediastinal drainage catheter. In addition, in this study, occult fistula was not included in the anastomotic fistula group when invasive treatment was not required.
次要结局
未报告次要终点
研究者
Yongtao Han
Director,Head of Thoracic Surgery
Sichuan Cancer Hospital and Research Institute