Haemostatic Gel Prophylaxis for Post Duodenal Endoscopic Resection Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Bleeding rate requiring further intervention within 30 days
研究概览
简要总结
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.
详细描述
This is a post-marketing follow-up study of a CE marked medical device, controlled, comparative, randomized, multicentre, international single-blind.
The main objective is to evaluate the efficacy and safety of PuraStat in duodenal endoscopic mucosal resection or ampullectomy.
This study will be carried out in France in 3 investigative centers. The duration of patient participation in the study is approximately 37 days depending on the time between the selection and the endoscopic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single blind
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
- •Ampullary lesions
- •Single ampullary lesion ≥ 10mm
- •Resection via hot ampullectomy, injection/Endoscopic mucosal resection of adjacent lateral spreading component Duodenal Lesions
- •≤ 2 lesions
- •Lesion ≥15mm
- •Resection via hot Endoscopic mucosal resection
- •Morphology: 0-Is, 0-IIa/b/c or combination, submucosal lesions
排除标准
- •Inability to provide informed consent (including people with cognitive impairment);
- •Pregnant or breastfeeding women;
- •Allergy to PuraStat®;
- •"Cold" mucosal endoscopic resection;
- •Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- •Participating patient, or in a period of exclusion from another clinical trial;
- •Patient not benefiting from a social security scheme.
结局指标
主要结局
Bleeding rate requiring further intervention within 30 days
时间窗: 30 days
Rate of clinically significant delayed postoperative bleeding requiring further intervention within 30 days (such as blood transfusion, packed cell transfusion or administration of other blood products, hospitalization or repeat endoscopy)
次要结局
未报告次要终点