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

NCT03624517 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Pro00027015
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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.

Conditions

Esophageal Varices; Liver Cirrhoses; Bleeding Esophageal Varices; Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed

  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

  72 hours

Secondary Outcomes (2)

• Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed

  7 days and 30 days

• Survival at 7 Days and 30 Days After Control of Initial Bleed

  7 days and 30 days

Study Arms (2)

24-hour octreotide infusion

EXPERIMENTAL

Patients will receive octreotide infusion over 24 hours

Drug: Octreotide

72-hour octreotide infusion

ACTIVE COMPARATOR

Patients will receive octreotide infusion over 72 hours

Drug: Octreotide

Interventions

Octreotide DRUG

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

24-hour octreotide infusion; 72-hour octreotide infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ohio State University: collaborator
• University of Texas Southwestern Medical Center: collaborator
• University of Florida Health: collaborator

Study Sites (8)

University of Florida Health

Jacksonville, Florida, 32209, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

The Ohio state University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Brooke Army Medical Center

Houston, Texas, 78234, United States

Location

Related Publications (1)

• Allam J, De Melo S, Feagins LA, Agrawal D, Malespin M, Shuja A, Lara LF, Rockey DC. Comparison of 24 vs 72-hr octreotide infusion in acute esophageal variceal hemorrhage - A multi-center, randomized clinical trial. Am J Med Sci. 2025 Jan;369(1):71-76. doi: 10.1016/j.amjms.2024.08.027. Epub 2024 Sep 4.

  PMID: 39241828 RESULT

MeSH Terms

Conditions

Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Don Rockey
• Organization: Medical University of South Carolina

rockey@musc.edu

(843) 792-6982

Study Officials

• Don Rockey, M.D

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 10, 2018
• Study Start: September 19, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)