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

Phase 4

Terminated

• Conditions: Esophageal Varices; Bleeding Esophageal Varices; Liver Cirrhoses; Upper Gastrointestinal Bleeding
• Interventions: Drug: Octreotide

• Registration Number: NCT03624517
• Lead Sponsor: Medical University of South Carolina

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Study Start: 2018-09-19
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
72-hour octreotide infusion	Octreotide	Patients will receive octreotide infusion over 72 hours
24-hour octreotide infusion	Octreotide	Patients will receive octreotide infusion over 24 hours

Primary Outcome Measures

Name	Time	Method
Esophageal varices rebleed within 72-hours after control of initial bleed	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 Outcome Measures

Name	Time	Method
Esophageal varices rebleed at 7 days and 30 days after control of initial bleed	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	7 days and 30 days	Survival at 7 days and 30 days.

Trial Locations

Locations (8)

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