Back to resultsLife-2023-02 Esophagogastric Variceal Bleeding
Primary Purpose
Acute Esophageal Variceal Hemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Growth Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Acute Esophageal Variceal Hemorrhage
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;
Sites / Locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.
Participants in this group will not take growth inhibitor treatment after endoscopic treatment.
Outcomes
Primary Outcome Measures
rebleeding rate after the endoscopic treatment in Group A at 1 month
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
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
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
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
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
record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
Secondary Outcome Measures
Full Information
NCT ID
NCT06011980
First Posted
August 22, 2023
Last Updated
August 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT06011980
Brief Title
Life-2023-02 Esophagogastric Variceal Bleeding
Official Title
Life-2023-02 Study on the Efficacy of Growth Inhibitors After Endoscopic Treatment of Acute Esophagogastric Variceal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
May 10, 2026 (Anticipated)
Study Completion Date
August 10, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Esophageal Variceal Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Participants in this group will not take growth inhibitor treatment after endoscopic treatment.
Intervention Type
Drug
Intervention Name(s)
Growth Inhibitor
Intervention Description
growth inhibitors for 250-500μg/h, ivgtt. for 5 days
Primary Outcome Measure Information:
Title
rebleeding rate after the endoscopic treatment in Group A at 1 month
Description
record the rebleeding incidence in this group A; (Rate A1= the number of rebleeding participants/the number of all the participants)
Time Frame
1 month after the endoscopic treatment
Title
rebleeding rate after the endoscopic treatment in Group A at 3 months
Description
record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)
Time Frame
3 months after the endoscopic treatment
Title
rebleeding rate after the endoscopic treatment in Group A at 6 months
Description
record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)
Time Frame
6 months after the endoscopic treatment
Title
rebleeding rate after the endoscopic treatment in Group B at 1 month
Description
record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)
Time Frame
1 month after the endoscopic treatment
Title
rebleeding rate after the endoscopic treatment in Group B at 3 months
Description
record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)
Time Frame
3 months after the endoscopic treatment
Title
rebleeding rate after the endoscopic treatment in Group B at 6 months
Description
record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
Time Frame
6 months after the endoscopic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEI WEI
Phone
15267175186
Email
wwze@zju.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine, Zhejiang University
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WEI WEI
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
on request
Learn more about this trial
Life-2023-02 Esophagogastric Variceal Bleeding
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