Clinical trial NCT03624517: Comparison of 24-hours Versus 72-hours of Octreotide Infusion in Preventing Early Rebleed From Esophageal Varices
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Esophageal Varices
Liver Cirrhoses
Bleeding Esophageal Varices
Upper Gastrointestinal Bleeding
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of Texas Southwestern Medical Center
name: University of Florida Health
First posted: 2018-08-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Esophageal varices rebleed within 72-hours after control of initial bleed
timeFrame: 72 hours
Secondary outcomes:
measure: Esophageal varices rebleed at 7 days and 30 days after control of initial bleed
timeFrame: 7 days and 30 days
measure: Survival at 7 days and 30 days after control of initial bleed
timeFrame: 7 days and 30 days
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Health
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Columbus
country: United States
facility: The Ohio state University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Medical University of South Carolina
name: Don Rockey, M.D
role: PRINCIPAL_INVESTIGATOR
References: