Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AdventHealth
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Post endoscopic mucosal resection bleeding
研究概览
简要总结
Our hypothesis is that prophylactic administration of 5 days of Octreotide following EMR or ampullectomy in patients with duodenal and ampullary adenomas greater than or equal to 10mm.
详细描述
Inclusion Criteria:
Duodenal or ampullary adenoma greater than or equal to 10mm. Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection.
Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female
Exclusion criteria:
Duodenal or ampullary adenoma <10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide Informed Consent Less than 18 years old Allergy to Octreotide
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duodenal or ampullary adenoma greater than or equal to 10mm Duodenal or ampullary adenoma that is suitable for endoscopic mucosal resection Medically fit for anesthesia, endoscopy, and EMR Able to provide Informed Consent 18 years or older, male and female
排除标准
- •Duodenal or ampullary adenoma <10mm Duodenal or ampullary adenoma that is not suitable for endoscopic mucosal resection Medically unfit for anesthesia, endoscopy, or EMR Unable to provide informed consent Less than 18 years old Allergy to Octreotide
研究组 & 干预措施
Octreotide
Octreotide 100mcg subcutaneous every 8 hours for 5 days
干预措施: octreotide (Drug)
no octreotide
No Octreotide
干预措施: No Octreotide (Other)
结局指标
主要结局
Post endoscopic mucosal resection bleeding
时间窗: 3 days
clinical evidence of a bleed, including melena, hematochezia, hematemesis
次要结局
未报告次要终点