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
- 招募中
- 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
- •Inclusion criteria Preoperatively
- •Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
- •Subjects with esophageal carcinoma (distal until Siewert II) scheduled for elective minimally invasive Ivor Lewis esophagectomy (cT1-4a,N0-3,M0).
- •Intra-operatively
- •- Intrathoracic circular stapled esophagogastric anastomosis
排除标准
- •preoperatively
- •Female patients who are pregnant or nursing
- •Participation in another study involving investigational drugs or devices.
- •Use of Avastin within 30 days prior to surgery
- •ASA IV (patient with severe systemic disease that is a constant threat to life)
- •Patients with other malignancies
- •Patients with previous esophageal or gastric surgery
- •Known hypersensitivity to batroxobin and tranexamic acid.
- •HB level < 8 g/dL
- •Patients on medicine containing acetylsalicylic acid not able to stop using the medicine for medical reasons minimum 3 days before taking the blood sampling.
- •Patients on clopidogrel not able to stop clopidogrel for medical reasons 7 days before blood sampling
- •Patients on other platelet aggregation inhibitor therapies not able to stop using the platelet aggregation inhibitor therapies for 3 days before taking the blood sample.
- •Intra-operatively
- •Intra-operative findings that may preclude conduct of the study procedures, such as pleural metastasis, tumor invasion in other organs, …
- •Anastomosis preformed differently than the standard of care
- •Excessive bleeding (>500 ml) prior to anastomosis
研究组 & 干预措施
study group
For the study group, a unit of autologous BioMatrix OBSiDiAN will be produced. Blood sample (120ml) will be taken after randomization at the ending of the abdominal phase of the surgery. The surgeon will create an esophagogastric anastomosis, after ruling out tension or torsion. Around 1-2ml of autologous BioMatrix OBSiDiAN will be applied on the distal/or proximal resection stump before the stapled anastomose will be created. After firing the standard circular device and creation of a functional anastomosis, a further 2.5-3ml OBSiDiAN must be applied circumferentially on the outside on the anastomosis. Once application is completed, a 30 seconds waiting period is required before putting the esophagus back into the surgical field (study specific). A methylene blue leakage test or other leakage test is performed (standard of care). If there is a leak, the anastomosis will be corrected or the completed procedure has to be done again.
干预措施: Obsidian (Device)
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
- 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)
- mortality(from surgery until 30 days post operative)
- inflammation WBC(from date of randomisation to postoperative day 5)
- 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)