Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Enrolling

Conditions: Acute Variceal Bleeding; Acute Upper Gastrointestinal Bleeding

Treatments: Procedure: Endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06031402

XHNKKY-ENDO-AVB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 368 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

Early endoscopy group

Experimental group

Description:

Intervention of endoscopy is within 12 hours after admission

Treatment:

Procedure: Endoscopy

Delayed endoscopy group

Active Comparator group

Description:

Intervention of endoscopy is within 12-24 hours after admission

Treatment:

Procedure: Endoscopy