Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding

Study Overview
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Brief Summary
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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
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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.

Official Title
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Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding

Conditions
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Acute Upper Gastrointestinal Bleeding, Acute Variceal Bleeding

Intervention / Treatment
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* Procedure: Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with AUGIB which is highly suspected to be caused by gastroesophageal variceal rupture; patients with a diagnosis of liver cirrhosis based on imaging and pathology; patients and/or their relatives who sign informed consents; patients' age ≥18 years. Exclusion Criteria: patients who have undergone endoscopy at other hospitals before admissions; patients' hemodynamics are unstable after resuscitation; patients with severe cardiovascular or cerebrovascular diseases or renal injury; patients who have taken anticoagulants or antiplatelet drugs within 2 weeks before admissions, or are diagnosed with severe hematological diseases; patients with human immunodeficiency virus or other acquired or congenital immune deficiency diseases; patients with mental illness; pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Before enrollment, all patients and/or their relatives will be informed about the study protocol, and sign the written informed consent forms. Eligible patients are randomly assigned at a ratio of 1:1 to early endoscopy group (within 12 hours after admission) and delayed endoscopy group (within 12-24 hours after admission)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early endoscopy group<br>Intervention of endoscopy is within 12 hours after admission | Procedure: Endoscopy<br>* Endoscopy<br>|
| Active Comparator: Delayed endoscopy group<br>Intervention of endoscopy is within 12-24 hours after admission | Procedure: Endoscopy<br>* Endoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The failure to control bleeding after admissions | 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. | within 5 days admission | 
| 6-week rebleeding | Rebleeding is defined as new onset of hematemesis or melena after successful treatment. | 6-week | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, variceal bleeding, gastrointestinal bleeding, endoscopy, survival, randomized controlled trial