Life-2023-02 Esophagogastric Variceal Bleeding

Not Applicable

Recruiting

• Conditions: Acute Esophageal Variceal Hemorrhage
• Interventions: Drug: Growth Inhibitor

• Registration Number: NCT06011980
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25
• Primary Completion: 2026-05-10
• Study Completion: 2026-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Growth Inhibitor	Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.

Primary Outcome Measures

Name	Time	Method
rebleeding rate after the endoscopic treatment in Group A at 1 month	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	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	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	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	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	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)

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hanzhou, Zhejiang, China