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

Liver Cirrhoses Clinical Trial

— LOVARB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03624517
• Other study ID #: Pro00027015
• Status: Recruiting
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: Jad Allam, M.D
• Phone: 8438767233
• Email: allamja[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Esophageal Varices
• Esophageal and Gastric Varices
• Esophageal Varices
• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhoses
• Liver Cirrhosis
• Upper Gastrointestinal Bleeding
• Varicose Veins

Intervention

Drug:
• Octreotide
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois at Chicago	Chicago	Illinois
United States	The Ohio state University	Columbus	Ohio
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Brooke Army Medical Center	Houston	Texas
United States	University of Florida Health	Jacksonville	Florida
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of South Carolina	Ohio State University, University of Florida Health, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Survival at 7 days and 30 days after control of initial bleed	Survival at 7 days and 30 days.	7 days and 30 days