Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

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

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.

Study Overview

• Status: Completed
• Conditions: Portal Hypertension; Cirrhosis, Liver; Varice Bleed
• Intervention / Treatment: Device: emergency endoscopic therapy

• Study Type: Observational
• Enrollment (Actual): 3300

Contacts and Locations

Study Locations

• China
  • Lanzhou, China
    • The First Hospital of Lanzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Complete demographic and clinical data of patients with cirrhosis associated with AVB who underwent emergency endoscopy within 24 hours between February 2013 and May 2020 across 34 university hospitals from 30 cities in China was retrospectively reviewed. Two independent investigators (Liu C and Huang Y) reviewed the medical records, including demographic, laboratory, clinical and endoscopic data.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
urgent endoscopy group; endoscopy <6h after admission	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.
early endoscopy group; endoscopy 6-24h after admission	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the incidence of 5-day rebleeding after emergency endoscopy	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the in-hospital mortality	6 months
need for ICU	6 months
the length of hospital stay	6 months

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Collaborators: LanZhou University; Beijing 302 Hospital; Beijing Shijitan Hospital, Capital Medical University; Sir Run Run Shaw Hospital; Tianjin Third Central Hospital; Linyi People's Hospital; The Sixth People's Hospital of Shenyang; Shanxi Bethune Hospital

Publications and helpful links

General Publications

• Chen PH, Chen WC, Hou MC, Liu TT, Chang CJ, Liao WC, Su CW, Wang HM, Lin HC, Lee FY, Lee SD. Delayed endoscopy increases re-bleeding and mortality in patients with hematemesis and active esophageal variceal bleeding: a cohort study. J Hepatol. 2012 Dec;57(6):1207-13. doi: 10.1016/j.jhep.2012.07.038. Epub 2012 Aug 8.
• Lau JYW, Yu Y, Tang RSY, Chan HCH, Yip HC, Chan SM, Luk SWY, Wong SH, Lau LHS, Lui RN, Chan TT, Mak JWY, Chan FKL, Sung JJY. Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding. N Engl J Med. 2020 Apr 2;382(14):1299-1308. doi: 10.1056/NEJMoa1912484.
• European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available. Erratum In: J Hepatol. 2018 Nov;69(5):1207.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 23, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: CHESS1905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No