Octreotide Infusion Duration for Esophageal Varices

(LOVARB Trial)

Recruiting at 7 trial locations

Overseen By Jad Allam, M.D

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Medical University of South Carolina

Disqualifiers: Gastric varices, TIPS history, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24-72 hours

34 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

Who Is on the Research Team?

Don Rockey, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: 24-hour octreotide infusion Experimental Treatment 1 Intervention

Patients will receive octreotide infusion over 24 hours

Group II: 72-hour octreotide infusion Active Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. Sung, JJ., Chung, SC., Lai, CW., et al.[2019]

Chronic administration of octreotide in rats with early-stage cirrhosis significantly reduced portal vein pressure, which is crucial in preventing the development of esophageal varices.

Morphometric analysis showed that octreotide-treated rats had a notable decrease in both the total area of submucosal vessels and the size of the most dilated submucosal vessel, indicating that octreotide can effectively mitigate the progression of vascular changes associated with cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of early octreotide administration on the development of esophageal varices in cirrhotic rats. Ballas, KD., Tzioufa-Asimakopoulou, V., Marakis, G., et al.[2020]

In a study of 16 stable cirrhotic patients, octreotide infusion significantly reduced the transhepatic venous gradient by 30% without affecting systemic blood pressure, indicating its potential effectiveness in managing portal hypertension.

In a separate trial with 40 patients experiencing active variceal bleeding, octreotide was as effective as oesophageal tamponade in controlling the bleeding, with better tolerance and fewer side effects reported in the octreotide group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of octreotide in oesophageal varices. McKee, R.[2018]

Octreotide is at least as effective as vasopressin for treating acute bleeding from esophageal varices, with fewer severe side effects and a reduced need for blood transfusions.

Current studies on octreotide have involved small patient groups, highlighting the need for larger controlled trials to better assess its efficacy, optimal dosing, and cost-effectiveness compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octreotide or vasopressin for bleeding esophageal varices. Law, AW., Gales, MA.[2019]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing octreotide and vasopressin in the control of acute esophageal variceal bleeding. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Use of octreotide in the acute management of bleeding esophageal varices. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Octreotide infusion or emergency sclerotherapy for variceal haemorrhage. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of early octreotide administration on the development of esophageal varices in cirrhotic rats. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A study of octreotide in oesophageal varices. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Octreotide or vasopressin for bleeding esophageal varices. [2019]