Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

NCT04957875 | Completed

• 1 other identifier: CHESS1905
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the incidence of 5-day rebleeding after emergency endoscopy

  6 months

Secondary Outcomes (3)

• the in-hospital mortality

  6 months

• need for ICU

  6 months

• the length of hospital stay

  6 months

Study Arms (2)

urgent endoscopy group

endoscopy \<6h after admission

Device: emergency endoscopic therapy

early endoscopy group

endoscopy 6-24h after admission

Device: emergency endoscopic therapy

Interventions

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.

early endoscopy group; urgent endoscopy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The first hospital of Lanzhou university

Lanzhou, China

Location

Related Publications (3)

• 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.

  PMID: 29653741 BACKGROUND

• 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.

  PMID: 32242355 BACKGROUND

• 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.

  PMID: 22885718 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Institute of Portal Hypertension, The First Hospital of Lanzhou University

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 12, 2021
• Study Start: December 16, 2019
• Primary Completion: December 16, 2019
• Study Completion: June 2, 2020
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)