NCT06031402

Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Upper Gastrointestinal Bleeding
• Acute Variceal Bleeding

Interventions

Type	Name	Description
PROCEDURE	Endoscopy	Endoscopy

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-09-11
• Last updated: 2025-02-27

Locations

1 site across 1 country: China