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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Esophageal Varices, Liver Cirrhoses, Bleeding Esophageal Varices, Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: Octreotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24-hour octreotide infusion<br>Patients will receive octreotide infusion over 24 hours | Drug: Octreotide<br>* Octreotide infusion for 24-hours in patients with bleeding esophageal varices.<br>|
| Active Comparator: 72-hour octreotide infusion<br>Patients will receive octreotide infusion over 72 hours | Drug: Octreotide<br>* Octreotide infusion for 24-hours in patients with bleeding esophageal varices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal varices rebleed within 72-hours after control of initial bleed | Rebleeding within 72-hours will be defined as any of the following: A drop in hemoglobin by more than 20 percentage points from baseline Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena Transfusion of >2 unites packed red blood cells after esophageal band ligation Recurrence of hematemesis or ongoing melena Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal varices rebleed at 7 days and 30 days after control of initial bleed | Rebleeding after 72-hours will be defined as: Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) Drop in hemoglobin by more than 20 percentage points OR the need for >2 units packed red blood cells Need for TIPS or surgery to control suspected bleeding | 7 days and 30 days | 
| Survival at 7 days and 30 days after control of initial bleed | Survival at 7 days and 30 days. | 7 days and 30 days |