Octreotide Infusion Duration for Esophageal Varices
(LOVARB Trial)
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does not mention any specific requirements to stay on or stop existing medications.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Octreotide Infusion Duration for Esophageal Varices is an effective drug?
The available research shows that octreotide is effective in controlling bleeding from esophageal varices. In one study, octreotide controlled bleeding in 88% of patients within 6 hours, compared to 54% for another drug, vasopressin. Another study found that octreotide and a procedure called sclerotherapy were equally effective, but octreotide had fewer side effects. Overall, octreotide is shown to be effective and has fewer side effects compared to some alternatives.12345
What data supports the effectiveness of the drug octreotide for treating esophageal varices?
What safety data exists for octreotide in treating esophageal varices?
Octreotide has been shown to be effective in controlling acute esophageal variceal bleeding with fewer side effects compared to vasopressin. Common side effects include headache, chest pain, and abdominal pain, which are less frequent with octreotide than with vasopressin. It is generally well-tolerated and has been used safely in patients without serious cardiovascular disease. However, the optimal dosage, duration, and route of administration are still under investigation, and more controlled trials are needed to fully establish its safety profile.12456
Is octreotide safe for use in humans?
Is the drug Octreotide a promising treatment for esophageal varices?
How does the drug octreotide differ from other treatments for esophageal varices?
Octreotide is unique because it is a synthetic version of a natural hormone that helps control bleeding by reducing blood flow to the esophageal varices, and it is administered through an infusion, which is simple and has fewer side effects compared to other treatments like vasopressin or sclerotherapy.12345
What is the purpose of this trial?
This trial compares the safety and effectiveness of shorter versus longer octreotide infusion in cirrhotic patients with bleeding esophageal varices. Octreotide helps lower blood pressure in liver vessels, reducing bleeding risks. The study aims to see if a shorter treatment duration is just as safe and effective, potentially lowering hospital costs. Octreotide is a synthetic long-acting somatostatin analogue used to control acute esophageal variceal bleeding by reducing variceal blood flow and pressure.
Research Team
Don Rockey, MD
Principal Investigator
Medical University of South Carolina
Eligibility Criteria
This trial is for adults with cirrhosis who have had an upper gastrointestinal bleed due to bleeding esophageal varices and need band ligation. They must be able to consent or have a representative do so. Excluded are those with GI cancer, recent variceal bleeding, prior shunt surgery, pregnancy, incarceration, severe recent illness, non-cirrhotic portal hypertension or octreotide allergy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a 24-hour or 72-hour octreotide infusion along with endoscopic therapy
Follow-up
Participants are monitored for rebleeding and survival at 7 and 30 days after control of initial bleed
Treatment Details
Interventions
- Octreotide
Octreotide is already approved in United States, European Union for the following indications:
- Acromegaly
- Severe diarrhea for carcinoid syndrome
- Acromegaly
- Symptoms associated with carcinoid tumors and vasoactive intestinal peptide secreting tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborator
Ohio State University
Collaborator
University of Florida Health
Collaborator