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

Medical University of South Carolina (MUSC)

Status and phase: Terminated; Phase 4

Conditions: Liver Cirrhoses; Esophageal Varices; Bleeding Esophageal Varices; Upper Gastrointestinal Bleeding

Treatments: Drug: Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT03624517

Pro00027015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

24-hour octreotide infusion

Experimental group

Description:

Patients will receive octreotide infusion over 24 hours

Treatment:

Drug: Octreotide

72-hour octreotide infusion

Active Comparator group

Description:

Patients will receive octreotide infusion over 72 hours

Treatment:

Drug: Octreotide