Life-2023-02 Esophagogastric Variceal Bleeding

August 22, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
          • Wei Wei

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Participants in this group will take growth inhibitors for 5 days after endoscopic treatment.
Drug: Growth Inhibitor
growth inhibitors for 250-500μg/h, ivgtt. for 5 days
No Intervention: Group B
Participants in this group will not take growth inhibitor treatment after endoscopic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
record the rebleeding incidence in this group A; (Rate A2= the number of rebleeding participants/the number of all the participants)
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
record the rebleeding incidence in this group A; (Rate A3= the number of rebleeding participants/the number of all the participants)
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
record the rebleeding incidence in this group B; (Rate B1= the number of rebleeding participants/the number of all the participants)
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
record the rebleeding incidence in this group B; (Rate B2= the number of rebleeding participants/the number of all the participants)
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
record the rebleeding incidence in this group B; (Rate B3= the number of rebleeding participants/the number of all the participants)
6 months after the endoscopic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

May 10, 2026

Study Completion (Estimated)

August 10, 2026

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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