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Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

NCT04957875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3300

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Cirrhosis, Liver
  • Portal Hypertension
  • Varice Bleed

Interventions

DEVICE

emergency endoscopic therapy

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.

Sponsors & Collaborators

  • LanZhou University

    collaborator OTHER

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Beijing 302 Hospital

    collaborator OTHER

  • Tianjin Third Central Hospital

    collaborator OTHER

  • The Sixth People's Hospital of Shenyang

    collaborator OTHER

  • Shanxi Bethune Hospital

    collaborator OTHER

  • Linyi People's Hospital

    collaborator OTHER

  • Sir Run Run Shaw Hospital

    collaborator OTHER

  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2019-12-16
Completion
2020-06-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957875 on ClinicalTrials.gov