Timing of endoscopy for cirrhotic patients with variceal bleeding

Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

This study is testing whether doing an endoscopy sooner or later helps cirrhotic patients with variceal bleeding have better outcomes, like controlling bleeding and reducing the risk of dying.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 368 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06031402 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the optimal timing of endoscopy for cirrhotic patients experiencing acute variceal bleeding. A total of 368 patients will be enrolled and randomly assigned to undergo endoscopy either early (within 12 hours of admission) or delayed (within 12-24 hours of admission). The study aims to evaluate the impact of these timing strategies on critical outcomes such as bleeding control, rebleeding rates, and mortality. By stratifying patients based on liver function and hemodynamic status, the trial seeks to provide clearer guidance on endoscopy timing in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with liver cirrhosis and suspected variceal bleeding.

Not a fit: Patients with unstable hemodynamics, severe comorbidities, or those who have undergone prior endoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and outcomes for patients with acute variceal bleeding.

How similar studies have performed: Previous studies on endoscopy timing in similar patient populations have shown mixed results, indicating the need for further investigation.

Eligibility criteria

Inclusion Criteria:

1. patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal 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 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 before admissions, or are diagnosed with severe hematological diseases;
5. patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases;
6. patients with mental illness;
7. pregnancy.

Where this trial is running

Shenyang, Liaoning

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

Study contacts

• Principal investigator: Xingshun Qi, MD — General Hospital of Shenyang Military Area
• Study coordinator: Xingshun Qi, MD

Conditions Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding; liver cirrhosis; variceal bleeding; gastrointestinal bleeding; endoscopy; survival; randomized controlled trial