The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

Study Overview
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Brief Summary
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This study is a prospective, multi-center and observational clinical study. Investigators would like to explore the optimal emergency endoscopy timing in cirrhosis patients with esophagogastric variceal bleeding (EGVB) by evaluating and comparing the efficacy and safety of emergency endoscopy performed at different times ( within 6 hours or between 6 and 24 hours after gastroenterologic consultation ) and its impact on the short-term prognosis.

Detailed Description
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Between July 2021 and April 2022, patients with cirrhosis undergoing emergency endoscopy due to EGVB are enrolled consecutively according to the following criteria: (1) age≥18 years; (2) A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination); (3) The cause of bleeding was identified as esophageal and/or gastric vein rupture. Exclusion criteria are as follows: (1) End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma); (2) The subject (or legal representative/guardian) refused to sign the informed consent. Patients were divided into urgent-endoscopy group (< 6h) and early-endoscopy group (6h-24h) according to the time interval from gastroenterologic consultation to the start of emergency endoscopy. Investigators will collect patients' data of baseline character, treatment, postoperative and follow-up. All patients will be followed up until death or the end of the study.

Official Title
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A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

Conditions
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Liver Cirrhosis, Portal Hypertension, Esophageal Varix Bleeding

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥18 years A definite diagnosis of cirrhosis (confirmed by medical history, laboratory examination and imaging examination) The cause of bleeding was identified as esophageal and/or gastric vein rupture Exclusion Criteria: End-stage diseases of major organs (such as heart failure, chronic obstructive pulmonary disease, end-stage renal disease, and malignancies other than hepatocellular carcinoma) The subject (or legal representative/guardian) refused to sign the informed consent

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| urgent-endoscopy group<br>the time interval from gastroenterologic consultation to the start of emergency endoscopy < 6 hours | |
| early-endoscopy group<br>the time interval from gastroenterologic consultation to the start of emergency endoscopy between 6 and 24 hours | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six-week mortality rate | Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis. | 6 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate success hemostasis rate | Successful immediate hemostasis refers to successful hemostasis under endoscopy, and no active bleeding manifestations such as hematemesis, hemorrhagic shock and progressive decline of hemoglobin within 24 hours. | within 24 hours after traetment | 
| five-day rebleeding rate | Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment. | 5 days after treatment | 
| detection rate of bleeding site | Identify the site of bleeding during endoscopy. | during endoscopy | 
| mean operating time | The time interval between the beginning and end of endoscopy. | during endoscopy | 
| the needs of salvage treatment | Salvage treatment refers to the additional three-chamber and two-capsule compression hemostasis, re-endoscopic therapy, interventional therapy or surgical treatment due to failure of hemostasis by emergency endoscopy or re-bleeding after successful hemostasis. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagogastric variceal bleeding, emergency endoscopy, timing