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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    160
  • sponsor
    Medical University of South Carolina
Updated on 12 February 2022
esophageal varices

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.

Description

In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices.

Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs.

This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.

Details
Condition Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices, Upper Gastrointestinal Bleeding
Treatment Octreotide
Clinical Study IdentifierNCT03624517
SponsorMedical University of South Carolina
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
Non-cirrhotic portal hypertension causing esophageal varices
Known or suspected allergy to octreotide
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