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

Last updated: January 8, 2025
Sponsor: Medical University of South Carolina
Overall Status: Terminated

Phase

4

Condition

Varicose Veins

Esophageal Disorders

Hyponatremia

Treatment

Octreotide

Clinical Study ID

NCT03624517
Pro00027015
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 authorizedrepresentative (LAR) provide consent if the patient is unable to do so

Exclusion

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 bandligation

  4. Variceal bleeding in the last 90 days

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

  6. Pregnant females

  7. Incarcerated individuals

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

  9. Non-cirrhotic portal hypertension causing esophageal varices

  10. Known or suspected allergy to octreotide

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Octreotide
Phase: 4
Study Start date:
September 19, 2018
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • University of Florida Health

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60607
    United States

    Site Not Available

  • The Ohio state University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • The University of Texas at Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Brooke Army Medical Center

    Houston, Texas 78234
    United States

    Site Not Available

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