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临床试验/NCT06011980
NCT06011980招募中不适用

Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
33
试验地点
1
主要终点
rebleeding rate after the endoscopic treatment in Group A at 1 month

研究概览

简要总结

Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding

详细描述

Participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. All the patients will take CTP test to confirm the blood flow status of the portal vein before endoscopic treatment. After that they will be randomly divided into two groups: A. accept growth inhibitors after the endoscopic treatment for 5 days; B. no growth inhibitor will be applied after the treatment.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute esophagogastric bleeding with hepatic cirhosis;
  • stable status (no active bleeding)

排除标准

  • endoscopic test limitation;
  • previous acute esophagogastric bleeding treatment history;
  • pregnant;
  • Immunity disabled;

研究组 & 干预措施

Group A

Experimental

Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.

干预措施: Growth Inhibitor (Drug)

结局指标

主要结局

rebleeding rate after the endoscopic treatment in Group A at 1 month

时间窗: 1 month after the endoscopic treatment

record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)

rebleeding rate after the endoscopic treatment in Group B at 1 month

时间窗: 1 month after the endoscopic treatment

record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)

rebleeding rate after the endoscopic treatment in Group B at 3 months

时间窗: 3 months after the endoscopic treatment

record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)

rebleeding rate after the endoscopic treatment in Group A at 3 months

时间窗: 3 months after the endoscopic treatment

record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)

rebleeding rate after the endoscopic treatment in Group A at 6 months

时间窗: 6 months after the endoscopic treatment

record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)

rebleeding rate after the endoscopic treatment in Group B at 6 months

时间窗: 6 months after the endoscopic treatment

record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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