Evaluation of Effectiveness and Safety of Autologous BioMatrix OBSiDiAN to Enhance a Stapled Circular Esophagogastric Anastomosis After Ivor Lewis Esophagectomy, a Phase II Study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Anastomotic leak
研究概览
简要总结
Oesophagectomy is very invasive surgery. A leakage at the level of the connection between oesophagus and stomach made during surgery causes a lot more problems and can lead to death. Studies show that the leakage rate sometimes goes up to 40 per cent. The chance of dying if you develop a leak after surgery is 15%, while the overall chance of dying during hospitalisation for this procedure is about 4%. We want to investigate whether the use of this new type of 'glue' (Obsidian®) can reduce the number of leaks. We invite you to participate in a clinical trial with the aim of investigating whether Obsidian® is safe and can reduce the number of leaks after oesophageal surgery in patients with oesophageal cancer. We want to apply a new type of 'glue', Obsidian®, at the level of the new connection between oesophagus and stomach.
详细描述
STUDY PRODUCT Autologous BioMatrix: Obsidian (medical device class III)
STUDY POPULATION Subjects ≥ 18 years and ≤ 75 years of age scheduled for elective Ivor Lewis esophagectomy for esophageal cancer with a circular stapled intrathoracic esophagogastric anastomosis.
SAMPLE SIZE A total of 90 patients will be included in the study. ENROLEMENT PERIOD Based on an annual number of 70-80 esophagectomies in University Hospital Ghent, we predict an enrolment period of 3 years.
STUDY DURATON Considering a 3 years enrolment period and a 1 year follow up we predict a study duration of 4 years.
PRIMAIRY ANALYSIS
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 (Participant)
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Anastomotic leak
时间窗: Absence of anastomotic leak within 30 days post operatively
Anastomotic leak defined according to the ECCG guidelines type I: local defect requiring no change in therapy or treated medicallly or with dietary modifications type II: localized defect requiring interventional but not surgical therapy, for example, interventional radiology drain, stent or bedside opening and packing or incision type III: localized defect requiring surgical therapy
次要结局
- mortality(from surgery until 30 days post operative)
- inflammation WBC(from date of randomisation to postoperative day 5)
- hospital stay(from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months)
- thoracic drainage duration(from surgery until removal of thoracic drain within the first week postoperative)
- sepsis(from surgery until 30 day post operative)
- pneumonia(from surgery until 30 day post operative)
- late anastomotic leakage(from surgery until 90 days post operative)
- stricture(from surgery until 1 year post operative)
- inflammation CRP(from date of randomisation to postoperative day 5)
- ICU stay(from surgery until discharge or until the date of death from any cause, whichever came first, assessed up to 3 months)
- thoracic drainage volume(from surgery until removal of thoracic drain within the first week postoperative)
- intra-operative checklist(peroperative)