34 Participants Needed

Octreotide Infusion Duration for Esophageal Varices

(LOVARB Trial)

Recruiting at 7 trial locations
KM
MH
SH
JA
Overseen ByJad Allam, M.D
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that octreotide is effective in controlling bleeding from esophageal varices, with fewer side effects compared to vasopressin. It also helps reduce portal vein pressure, which can prevent the development of esophageal varices.12345

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?

Octreotide has been shown to be generally safe in humans, with fewer side effects compared to vasopressin when used for bleeding esophageal varices. Common side effects like headache, chest pain, and abdominal pain were less frequent in patients treated with octreotide.12456

Is the drug Octreotide a promising treatment for esophageal varices?

Yes, Octreotide is a promising treatment for esophageal varices. It is effective in controlling bleeding, has fewer side effects compared to other treatments like vasopressin, and is easy to administer. It also helps reduce pressure in the veins, which can prevent further bleeding.12345

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

DR

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

I might have bleeding in my upper digestive tract.
I can give my consent for the study or have someone legally authorized to do so on my behalf.
I have had bleeding in my upper digestive tract due to swollen veins in my esophagus, treated with a specific procedure.
See 1 more

Exclusion Criteria

I have bleeding from stomach veins.
I have had bleeding from enlarged veins in my esophagus or stomach in the last 3 months.
People who are in prison.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a 24-hour or 72-hour octreotide infusion along with endoscopic therapy

24-72 hours

Follow-up

Participants are monitored for rebleeding and survival at 7 and 30 days after control of initial bleed

30 days

Treatment Details

Interventions

  • Octreotide
Trial Overview The study tests the effectiveness of two durations of octreotide infusion—24 hours versus 72 hours—in preventing rebleeding from esophageal varices after endoscopic banding in patients with liver cirrhosis.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-hour octreotide infusionExperimental Treatment1 Intervention
Patients will receive octreotide infusion over 24 hours
Group II: 72-hour octreotide infusionActive Control1 Intervention
Patients will receive octreotide infusion over 72 hours

Octreotide is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Sandostatin for:
  • Acromegaly
  • Severe diarrhea for carcinoid syndrome
🇪🇺
Approved in European Union as Sandostatin for:
  • 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

Trials
994
Recruited
7,408,000+

University of Texas Southwestern Medical Center

Collaborator

Trials
1,102
Recruited
1,077,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

University of Florida Health

Collaborator

Trials
10
Recruited
4,200+

Findings from Research

In a study of 48 cirrhotic patients with bleeding esophageal varices, octreotide was more effective than vasopressin for initial control of bleeding, achieving control in 88% of patients compared to 54% for vasopressin.
Octreotide also had significantly fewer side effects, with only 3 patients experiencing adverse effects compared to 11 in the vasopressin group, making it a safer option for managing acute bleeding.
A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding.Hwang, SJ., Lin, HC., Chang, CF., et al.[2019]
Octreotide is effective in managing acute hemorrhage from esophageal varices in cirrhotic patients, helping to halt initial bleeding and prevent reoccurrence, as shown in randomized controlled trials.
Compared to somatostatin, octreotide is a more cost-effective option with similar therapeutic efficacy, and it should be administered immediately for suspected variceal bleeding and continued for two to five days post-endoscopic treatment.
Use of octreotide in the acute management of bleeding esophageal varices.Sadowski, DC.[2019]
In a study of 100 patients with acute variceal hemorrhage, both octreotide infusion and emergency sclerotherapy were found to be equally effective in controlling bleeding, with initial control rates of 90% and 84%, respectively.
There were no significant differences in rebleeding rates, blood transfusion needs, hospital stays, or mortality between the two treatments, and octreotide showed no notable side effects, suggesting it is a safe alternative to sclerotherapy.
Octreotide infusion or emergency sclerotherapy for variceal haemorrhage.Sung, JJ., Chung, SC., Lai, CW., et al.[2019]

References

A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding. [2019]
Use of octreotide in the acute management of bleeding esophageal varices. [2019]
Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. [2019]
Effect of early octreotide administration on the development of esophageal varices in cirrhotic rats. [2020]
A study of octreotide in oesophageal varices. [2018]
Octreotide or vasopressin for bleeding esophageal varices. [2019]
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