2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, 310000, China
Location status: Recruiting
Location contact
WEI WEI
CONTACT
Recruiting
NCT Number: NCT06011980
Life-2023-02 Esophagogastric Variceal Bleeding
Study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Growth Inhibitor
Druggrowth inhibitors for 250-500μg/h, ivgtt. for 5 days
Primary outcomes
-
rebleeding rate after the endoscopic treatment in Group A at 1 month
Time frame: 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 A at 3 months
Time frame: 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
Time frame: 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 1 month
Time frame: 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
Time frame: 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 B at 6 months
Time frame: 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)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Registry information
Official study title
Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Aug 25, 2023
- Registry last updated
- Aug 25, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.