Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

Completed

• Conditions: Cirrhosis, Liver; Portal Hypertension; Varice Bleed
• Interventions: Device: emergency endoscopic therapy

• Registration Number: NCT04957875
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

Cirrhotic patients with AVB across 34 university medical centers in 30 cities in China from February 2013 to May 2020 who underwent endoscopy within 24 hours were included in this study. Patients were divided into an urgent endoscopy group (endoscopy \<6h after admission) and an early endoscopy group (endoscopy 6-24h after admission). Outcomes included the incidence of 5-day rebleeding, in-hospital mortality, need for intensive care unit (ICU) and the length of hospital stay after the endoscopy management. Multivariable analysis was performed to identify risk factors for rebleeding. A propensity score matching (PSM) analysis was performed to achieve a balance at baseline between the urgent and early groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-16
• Primary Completion: 2019-12-16
• Study Completion: 2020-06-02
• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-01
• Study First Posted: 2021-07-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3300

Inclusion Criteria

• established diagnosis of cirrhosis (based on liver biopsy or the combination of clinical, biochemical, and imaging findings)
• witnessed or reported evidence of gastrointestinal haemorrhage (hematemesis, melenemesis, or hematochezia)
• esophageal or gastric varices confirmed endoscopically as the source of bleeding

Exclusion Criteria

• severe dysfunction of a major extrahepatic organ (e.g., heart failure, pulmonary disease, and terminal malignancy except hepatocellular carcinoma)
• history of endoscopic therapy for varices (ligation or sclerotherapy) within three months
• incomplete or missing data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
urgent endoscopy group	emergency endoscopic therapy	endoscopy \<6h after admission
early endoscopy group	emergency endoscopic therapy	endoscopy 6-24h after admission

Primary Outcome Measures

Name	Time	Method
the incidence of 5-day rebleeding after emergency endoscopy	6 months

Secondary Outcome Measures

Name	Time	Method
need for ICU	6 months
the length of hospital stay	6 months
the in-hospital mortality	6 months

Trial Locations

Locations (1)

The first hospital of Lanzhou university; 🇨🇳 Lanzhou, China