Clinical trial NCT04957875: Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis
Official title: Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis, Liver
Portal Hypertension
Varice Bleed
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing 302 Hospital
name: Tianjin Third Central Hospital
name: The Sixth People's Hospital of Shenyang
name: Shanxi Bethune Hospital
name: Linyi People's Hospital
name: Sir Run Run Shaw Hospital
First posted: 2021-07-12
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: the incidence of 5-day rebleeding after emergency endoscopy
timeFrame: 6 months
Secondary outcomes:
measure: the in-hospital mortality
timeFrame: 6 months
measure: need for ICU
timeFrame: 6 months
measure: the length of hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The first hospital of Lanzhou university
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.