Safety and Efficacy of Closure of Postoperative Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection
排除标准
- •tubular ischemia of the upper GI tract
- •inability to provide informed consent
结局指标
主要结局
Safety
时间窗: 2 years
Endpoint to be recorded during hospital stay: Composite serious adverse event endpoint for 30 days after the diagnosis of anastomotic leakage including: * Death * Injury to vessels through the suture device, leading to bleeding or thrombosis * Cardiac tamponade, arrhythmia * Pneumothorax * Bleeding requiring transfusion * possible medium-term complications such as new mediastinal abscess
Technical feasibility
时间窗: 2 years
Technical success of the anastomotic closure
次要结局
- Time to healing of the anastomotic leak(2 years)
- Long term safety(6 months after diagnosis of anastomotic leakage)