Timing of Endoscopy in Cirrhotic Patients with Acute Variceal Bleeding

Not Applicable

Recruiting

• Conditions: Acute Upper Gastrointestinal Bleeding; Acute Variceal Bleeding
• Interventions: Procedure: Endoscopy

• Registration Number: NCT06031402
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-11
• Study Start: 2024-09-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 368

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed endoscopy group	Endoscopy	Intervention of endoscopy is within 12-24 hours after admission
Early endoscopy group	Endoscopy	Intervention of endoscopy is within 12 hours after admission

Primary Outcome Measures

Name	Time	Method
The failure to control bleeding after admissions	within 5 days admission	Failure to control bleeding is defined as any one of the three following conditions within 5 days admission: 1) vomiting of fresh blood; 2) suction of more than 100ml of fresh blood from the nasogastric tube; 3) a decrease in hemoglobin concentration of 30g/L in the absence of blood transfusion; or 4) death.
6-week rebleeding	6-week	Rebleeding is defined as new onset of hematemesis or melena after successful treatment.

Secondary Outcome Measures

Name	Time	Method
6-week all-cause mortality	6-week	Death.
Adverse events	up to 6 weeks	Adverse events include fever, chest pain, dysphagia, and perforation or pneumonia caused by endoscopy or anesthesia.

Trial Locations

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area); 🇨🇳 Shenyang, Liaoning, China