Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: Ohio State University; University of Florida Health; University of Texas Southwestern Medical Center
• Treatments: Octreotide

Criteria

Inclusion Criteria:

1. Adult males and females who are 18 years of age or older.

2. Evidence or suspicion of upper gastrointestinal bleed (GIB)

3. Patient with known or suspected cirrhosis

4. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation

5. Willing and able to provide informed consent for study, or have a Legally authorized representative (LAR) provide consent if the patient is unable to do so

Exclusion Criteria:

1. Known upper gastrointestinal malignancy

2. Bleeding from gastric varices, with or without esophageal varices

3. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation

4. Variceal bleeding in the last 90 days

5. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery

6. Pregnant females

7. Incarcerated individuals

8. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks

9. Non-cirrhotic portal hypertension causing esophageal varices

10. Known or suspected allergy to octreotide