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Completed

NCT Number: NCT04957875

Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

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.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Varice Bleed

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The first hospital of Lanzhou university

Lanzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

emergency endoscopic therapy

Device

When cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist.

Primary outcomes

  1. the incidence of 5-day rebleeding after emergency endoscopy

    Time frame: 6 months

Secondary outcomes

  1. the in-hospital mortality

    Time frame: 6 months

  2. need for ICU

    Time frame: 6 months

  3. the length of hospital stay

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Collaborators

  • Beijing 302 Hospital
  • Beijing Shijitan Hospital, Capital Medical University
  • LanZhou University
  • Linyi People's Hospital
  • Shanxi Bethune Hospital
  • Shenyang Sixth People's Hospital
  • Sir Run Run Shaw Hospital
  • Tianjin Third Central Hospital

Registry information

Official study title

Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 12, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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