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



Status:Recruiting
Conditions:Cardiology, Gastrointestinal, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:9/22/2018
Start Date:September 19, 2018
End Date:December 2021
Contact:Roula Sasso, M.D
Email:sasso@musc.edu

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Comparison of 24-hours Versus 72-hours of Octreotide Infusion Along With Endoscopic Therapy in Preventing Early Rebleed From Esophageal Varices: a Multi-center, Randomized Clinical Study

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.

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.

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
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-8000
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Dallas, Texas 75390
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655 West 8th Street
Jacksonville, Florida 32209
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