Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957875
• Other study ID #: CHESS1905
• Status: Completed
• Start date: December 16, 2019
• Est. completion date: June 2, 2020

Study information

• Verified date: April 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3300
• Est. completion date: June 2, 2020
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Varice Bleed

Intervention

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.

Locations

Country	Name	City	State
China	The first hospital of Lanzhou university	Lanzhou

Sponsors (9)

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

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of 5-day rebleeding after emergency endoscopy		6 months
Secondary	the in-hospital mortality		6 months
Secondary	need for ICU		6 months
Secondary	the length of hospital stay		6 months