Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Safety & Efficacy
研究概览
简要总结
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).
详细描述
The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).
This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.
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
- Triple (Participant, Care Provider, Investigator)
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
- •All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age
排除标准
- •Ulcerative esophagitis,
- •Mallory Weiss tear,
- •Bleeding gastric or duodenal ulcers,
- •Bleeding from gastric varices or portal hypertensive gastropathy and
- •Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.
研究组 & 干预措施
A
干预措施: Terlipressin (Drug)
B
干预措施: Octreotide (Drug)
结局指标
主要结局
Safety & Efficacy
时间窗: 5 days
次要结局
未报告次要终点