A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- The presence of active bleeding or high risk stigma of bleeding
研究概览
简要总结
PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Duodenal non-ampullary mucosal lesion ≥ 10 mm
- •≥ 18y of age
- •Informed consent obtained
排除标准
- •Ampulloma
- •Submucosal lesion
- •Lesion < 10 mm
- •>1 lesion resected
- •Active use of anticoagulant or antithrombotic medication other than aspirin
- •Known clotting disorder
- •Inability to give informed consent
- •< 18y of age
结局指标
主要结局
The presence of active bleeding or high risk stigma of bleeding
时间窗: 1 day after EMR
On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed
次要结局
- The presence of clinical signs of delayed bleeding('During hospital stay, assessed up to 10 days' and '30 days after EMR')
- The presence of other adverse events('During hospital stay, assessed up to 10 days' and '30 days after EMR')
- The feasibility of PuraStat application: Ease(During EMR procedure)
- The feasibility of PuraStat application: Amount(During EMR procedure)
- The feasibility of Purastat application: Coverage(During EGD procedure)
研究者
Prof. Dr. Raf Bisschops
Clinical professor
Universitaire Ziekenhuizen KU Leuven