Life-2023-02 Esophagogastric Variceal Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Growth Inhibitor.
- Who it may be relevant to
- Registry conditions: Acute Esophageal Variceal Hemorrhage. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
Overview
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.
Interventions
- Drug Growth Inhibitor
growth inhibitors for 250-500μg/h, ivgtt. for 5 days
Primary outcome measures
- rebleeding rate after the endoscopic treatment in Group A at 1 month [Time frame: 1 month after the endoscopic treatment]
- rebleeding rate after the endoscopic treatment in Group A at 3 months [Time frame: 3 months after the endoscopic treatment]
- rebleeding rate after the endoscopic treatment in Group A at 6 months [Time frame: 6 months after the endoscopic treatment]
- rebleeding rate after the endoscopic treatment in Group B at 1 month [Time frame: 1 month after the endoscopic treatment]
- rebleeding rate after the endoscopic treatment in Group B at 3 months [Time frame: 3 months after the endoscopic treatment]
- rebleeding rate after the endoscopic treatment in Group B at 6 months [Time frame: 6 months after the endoscopic treatment]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hanzhou
Identifiers
NCT: NCT06011980 · 2023-0407