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The Timing of Emergency Endoscopy for Esophagogastric Variceal Bleeding in Cirrhosis

W

Wuhan University

Status

Unknown

Conditions

Portal Hypertension
Liver Cirrhosis
Esophageal Varix Bleeding

Study type

Observational

Funder types

Other

Identifiers

NCT04932200
WDRY2021-K061

Details and patient eligibility

About

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.

Full 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.

Enrollment

608 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

608 participants in 2 patient groups

urgent-endoscopy group
Description:
the time interval from gastroenterologic consultation to the start of emergency endoscopy \< 6 hours
early-endoscopy group
Description:
the time interval from gastroenterologic consultation to the start of emergency endoscopy between 6 and 24 hours

Trial contacts and locations

1

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Central trial contact

Mingkai Chen, PHD

Data sourced from clinicaltrials.gov

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