The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

• Conditions: Esophageal Varix Bleeding; Liver Cirrhosis; Portal Hypertension

• Registration Number: NCT04932200
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-12
• Last Update Submitted: 2021-06-12
• Study Start: 2021-06-15
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 608

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
six-week mortality rate	6 weeks after treatment	Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.

Secondary Outcome Measures

Name	Time	Method
mean operating time	during endoscopy	The time interval between the beginning and end of endoscopy.
Immediate success hemostasis rate	within 24 hours after traetment	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.
the needs of salvage treatment	6 weeks	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.
detection rate of bleeding site	during endoscopy	Identify the site of bleeding during endoscopy.
five-day rebleeding rate	5 days after treatment	Patients rebleeded due to esophageal and gastric varices bleeding in five days after treatment.

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China