DRUG
Octreotide
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices
Status
Terminated
Phase
Phase 4
Enrollment
34
Locations
8
Results
Posted
Publications
1
Study summary
What the protocol is testing.
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 detailed 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 10, 2018
Study start
Sep 19, 2018
Primary completion
Dec 1, 2024
Study completion
Dec 1, 2024
Results posted
Nov 20, 2025
Registry updated
Nov 20, 2025
Outcomes
What the study measures.
Primary outcomes
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Time frame · 72 hours
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
Secondary outcomes
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Time frame · 7 days and 30 days
Rebleeding after 72-hours will be defined as: 1. Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells 3. Need for TIPS or surgery to control suspected bleeding
Survival at 7 Days and 30 Days After Control of Initial Bleed
Time frame · 7 days and 30 days
Survival at 7 days and 30 days.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
8 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Florida Health
Jacksonville, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
The Ohio state University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas at Austin
Austin, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Brooke Army Medical Center
Houston, Texas, United States
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More studies on Octreotide.
NCT IDStudyPhase / statusEnrollmentUpdated
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A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
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Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome
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RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
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Completed
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2026-07
Effect of Insulin Lowering on Lipogenesis
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Recruiting
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An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Camurus AB · Acromegaly
Not applicable
Recruiting
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2026-06
A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)
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