Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

Last updated: February 25, 2025
Sponsor: General Hospital of Shenyang Military Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Ulcers

Gastric Ulcers

Treatment

Endoscopy

Clinical Study ID

NCT06031402
XHNKKY-ENDO-AVB
  • Ages > 18
  • All Genders

Study Summary

Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in patients with liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of timing of endoscopy on the outcomes of cirrhotic patients with AVB.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. patients with AUGIB which is highly suspected to be caused by gastroesophagealvariceal rupture;

  2. patients with a diagnosis of liver cirrhosis based on imaging and pathology;

  3. patients and/or their relatives who sign informed consents;

  4. patients' age ≥18 years.

Exclusion

Exclusion Criteria:

  1. patients who have undergone endoscopy at other hospitals before admissions;

  2. patients' hemodynamics are unstable after resuscitation;

  3. patients with severe cardiovascular or cerebrovascular diseases or renal injury;

  4. patients who have taken anticoagulants or antiplatelet drugs within 2 weeks beforeadmissions, or are diagnosed with severe hematological diseases;

  5. patients with human immunodeficiency virus or other acquired or congenital immunedeficiency diseases;

  6. patients with mental illness;

  7. pregnancy.

Study Design

Total Participants: 368
Treatment Group(s): 1
Primary Treatment: Endoscopy
Phase:
Study Start date:
September 04, 2024
Estimated Completion Date:
December 31, 2026

Study Description

A total of 368 cirrhotic patients presenting with AUGIB that is highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and hemodynamic status at admission, and randomly assigned at a 1:1 ratio into early (within 12 hours after admission) and delayed (within 12-24 hours after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.

Connect with a study center

  • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

    Shenyang, Liaoning
    China

    Active - Recruiting

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