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Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
Overall Status
Completed
CT.gov ID
NCT04957875
Collaborator
LanZhou University (Other), Beijing Shijitan Hospital, Capital Medical University (Other), Beijing 302 Hospital (Other), Tianjin Third Central Hospital (Other), The Sixth People's Hospital of Shenyang (Other), Shanxi Bethune hospital, Shanxi, China (Other), Linyi People's Hospital (Other), Sir Run Run Shaw Hospital (Other)
3,300
Enrollment
1
Location
5.6
Actual Duration (Months)
594.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: emergency endoscopic therapy

Study Design

Study Type:
Observational
Actual Enrollment :
3300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Timing of Endoscopy for Acute Variceal Bleeding in Patients With Cirrhosis (CHESS1905): a Nationwide Cohort Study
Actual Study Start Date :
Dec 16, 2019
Actual Primary Completion Date :
Dec 16, 2019
Actual Study Completion Date :
Jun 2, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. the incidence of 5-day rebleeding after emergency endoscopy [6 months]

Secondary Outcome Measures

  1. the in-hospital mortality [6 months]

  2. need for ICU [6 months]

  3. the length of hospital stay [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first hospital of Lanzhou university Lanzhou China

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaolong Qi, Chief, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier:
NCT04957875
Other Study ID Numbers:
  • CHESS1905
First Posted:
Jul 12, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Cirrhosis
Hypertension, Portal
Fibrosis

Study Results

No Results Posted as of Jul 12, 2021