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Timing of Endoscopic Intervention for Acute Variceal Hemorrhage: an RCT
Sponsor: Jinling Hospital, China
Summary
Acute variceal upper gastrointestinal hemorrhage remains a hot potato in cirrhotic patients. The purpose of this study is to figure out whether urgent endoscopy (within 6h after gastroenterological consultation) is superior to non-urgent endoscopy (between 6h and 24h after gastroenterological consultation) in reducing rebleeding for these patients. This is a multi-centered, prospective, randomized, and controlled trial. 400 patients with suspected variceal bleeding will be randomized in a 1:1 ratio to receive endoscopic intervention either within 6h or 6-24h. Randomization is conducted by permuted block randomization stratified by age, systolic blood pressure (SBP), and pulse rate. The primary efficacy endpoint is rebleeding within 42 days after control of acute variceal hemorrhage. This trial will provide valuable insights into the efficacy between the urgent endoscopy group and the non-urgent endoscopy group.
Official title: Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2021-04-20
Completion Date
2026-02-28
Last Updated
2025-11-24
Healthy Volunteers
No
Interventions
endoscopic intervention
performing endoscopy
Locations (4)
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Wuxi People's Hospital of Nanjing Medical University
Wuxi, Jiangsu, China