NCT01970306已完成2 期
A Prospective Phase II Trial to Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Number of Participants With Anastomotic Leak.
研究概览
简要总结
The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years of age or older
- •Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal, adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at other institutions but slides must be confirmed at MSKCC or a participating site, as is routine care at our institution)
- •Patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. Including but not limited to esophagectomy or total gastrectomy.
- •Subject is willing to provide written informed consent
- •Subject is willing and able to comply with the follow-up regimen
排除标准
- •Pregnant or lactating women
- •Intraoperative evidence of metastatic or locally-unresectable disease
- •Patients with known sensitivity or allergy to porcine materials.
- •Patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.
结局指标
主要结局
Number of Participants With Anastomotic Leak.
时间窗: up to 10 days
Anastomotic leak will be assessed by clinical observation and one postoperative contrast study (thin-barium Gastrografin or Omnipaque swallow)
次要结局
- Stricture Formation Clinically and by Determination of Dysphagia Score(90 days postoperatively)
- Number of Participants Who Developed Anastomotic Stenosis(90 days post op)
研究者
研究点 (6)
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