TerminatedPhase 4

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

Stopped: Recruitment was severely affected due to COVID, so study was stopped prematurely.

United States34 participantsStarted 2018-09-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult males and females who are 18 years of age or older.
✓. Evidence or suspicion of upper gastrointestinal bleed (GIB)
✓. Patient with known or suspected cirrhosis
✓. Upper GIB secondary to bleeding esophageal varices as show by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation
✓. 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

✕. Known upper gastrointestinal malignancy
✕. Bleeding from gastric varices, with or without esophageal varices
✕. Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation
✕. Variceal bleeding in the last 90 days
✕. History of transjugular, intrahepatic, portosystemic shunt (TIPS) or vascular decompression surgery
✕. Pregnant females
✕. Incarcerated individuals
✕. Myocardial infarct, cerebrovascular accident, sepsis, respiratory failure, or severe intercurrent illness within the previous 6 weeks

What they're measuring

Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed

Timeframe: 72 hours

Trial details

NCT IDNCT03624517

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Results submitted2025-11-06

View on ClinicalTrials.gov More Esophageal Varices trials