A Prospective Multicenter Cohort Study on the Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Cirrhosis
- Sponsor
- Renmin Hospital of Wuhan University
- Enrollment
- 608
- Locations
- 1
- Primary Endpoint
- six-week mortality rate
- Last Updated
- 4 years ago
Overview
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.
Investigators
ChenMingkai
Professor
Renmin Hospital of Wuhan University
Eligibility Criteria
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
Outcomes
Primary Outcomes
six-week mortality rate
Time Frame: 6 weeks after treatment
Patients died in six weeks after emergency endoscopy due to rebleeding or other complications associated with cirrhosis.
Secondary Outcomes
- mean operating time(during endoscopy)
- Immediate success hemostasis rate(within 24 hours after traetment)
- the needs of salvage treatment(6 weeks)
- detection rate of bleeding site(during endoscopy)
- five-day rebleeding rate(5 days after treatment)