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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03624517
Other study ID # Pro00027015
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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