Timing of Endoscopic Intervention in Patients With Cirrhosis With Acute Variceal Upper Gastrointestinal Hemorrhage (TEACH Trial): a Randomized Clinical Trial

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• (I) patients who have pathological or clinical and imaging evidence indicating a diagnosis of cirrhosis; (II) patients with clinical symptoms associated with AVH (hematemesis, melena or hematochezia) before admission or during hospitalization; (III) patients who are hemodynamically stable before or after initial fluid resuscitation.

Locations
Other Locations
China
Affiliated Jinling Hospital, Medical School of Nanjing University
RECRUITING
Nanjing
First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
Taixing People's Hospital
RECRUITING
Taishing
The Affiliated Wuxi People's Hospital of Nanjing Medical University
RECRUITING
Wuxi
Contact Information
Primary
Zhuoxin Yang, M.D.
yzxbeyond@163.com
+8618761679906
Time Frame
Start Date: 2021-04-20
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 400
Treatments
Experimental: non-urgent endoscopy group
undergo endoscopy between 6 and 24 hours after gastroenterological consultation
Other: urgent endoscopy group
undergo endoscopy within 6 hours after gastroenterological consultation
Sponsors
Collaborators: The first affiliated Hospital of Nanjing Medical University, Jiangsu Province, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Taixing People's Hospital, The Affiliated Wuxi People's Hospital of Nanjing Medical University
Leads: Jinling Hospital, China

This content was sourced from clinicaltrials.gov