Octreotide Infusion Duration for Esophageal Varices

(LOVARB Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of different durations of octreotide infusion, a medication used to reduce bleeding, following variceal banding, a procedure for esophageal bleeding. It compares a 24-hour infusion to a 72-hour infusion in patients with cirrhosis (liver scarring) who have bleeding esophageal varices (enlarged veins in the esophagus). This study suits adults with cirrhosis who have experienced an upper gastrointestinal bleed due to these varices. Participants must have undergone an endoscopy, a procedure using a camera to inspect the esophagus, which required banding to stop the bleeding. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

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 is the safety track record for octreotide?

Research has shown that octreotide is generally safe for treating bleeding in the esophagus. Studies indicate it causes fewer major complications compared to other treatments, such as vasopressin. Specifically, a large study of over 2,000 patients found octreotide to be the safest among similar drugs, with the lowest risk of serious side effects. Overall, octreotide is well-tolerated, making it a reliable option for managing this condition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the different durations of octreotide infusions for esophageal varices because they might improve patient outcomes. Esophageal varices, often managed with endoscopic treatments and medications like beta-blockers, need effective and timely intervention to prevent bleeding. Unlike standard treatments, the 72-hour octreotide infusion could offer prolonged protection and stabilization by maintaining consistent drug levels in the body. Meanwhile, the 24-hour infusion could provide a quicker intervention option, potentially reducing hospital stays and healthcare costs while still offering effective management. By exploring these variations, researchers hope to find the most efficient and beneficial treatment duration for patients.

What evidence suggests that octreotide infusion is effective for esophageal varices?

Research shows that octreotide effectively stops bleeding in patients with esophageal varices, which are large swollen veins in the esophagus. This trial will compare two treatment arms: a 24-hour octreotide infusion and a 72-hour octreotide infusion. Studies indicate that both 24-hour and 72-hour infusions of octreotide effectively prevent further bleeding. One study even suggested that a shorter, 24-hour infusion works just as well as a 72-hour one. Octreotide controls bleeding better than other treatments. While current guidelines often recommend a 72-hour infusion, recent evidence supports that a shorter treatment may be just as effective. ^{2 6 7 8 9}

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]

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 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]

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. amjmedsci.com amjmedsci.com/article/S0002-9629(24)01443-5/fulltext

Comparison of 24 vs 72-hr octreotide infusion in acute ... A 24-hr infusion is non-inferior to a 72-hr infusion of octreotide for prevention of re-bleeding in patients with EVH.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39241828/

Comparison of 24 vs 72-hr octreotide infusion in acute ... A 24-hr infusion is non-inferior to a 72-hr infusion of octreotide for prevention of re-bleeding in patients with EVH.

3. gastrojournal.org gastrojournal.org/article/S0016-5085(01)49673-9/fulltext

Octreotide for acute esophageal variceal bleeding: A meta- ... Background & Aims: Studies of octreotide have not demonstrated a consistent benefit in efficacy or safety compared with conventional therapies.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25874510/

Comparison of 2 days versus 5 days of octreotide infusion ... Two days of octreotide infusion following endoscopic therapy is sufficient and as efficacious as 5 days of infusion in preventing early rebleed, with ...

5. news-medical.net news-medical.net/news/20241007/Less-is-more-in-octreotide-therapy-for-esophageal-variceal-hemorrhage.aspx

Less is more in octreotide therapy for esophageal variceal ... Comparison of 24 vs 72-hour octreotide infusion in acute esophageal variceal hemorrhage - a multi-center, randomized clinical trial. The ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11231948/

Octreotide for acute esophageal variceal bleeding: a meta- ... Background & aims: Studies of octreotide have not demonstrated a consistent benefit in efficacy or safety compared with conventional therapies.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK68564/

Octreotide for acute esophageal variceal bleeding - NCBI The results suggested that octreotide is more effective than vasopressin or terlipressin in the control of oesophageal variceal bleeding, and ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508501496739

Octreotide for acute esophageal variceal bleeding: A meta- ... Octreotide had comparable efficacy to immediate sclerotherapy for control of bleeding (RR, 0.94; 95% CI, 0.55–1.62), fewer major complications than vasopressin/ ...

9. nature.com nature.com/articles/s41598-024-56873-x

Real-world comparison of terlipressin vs. octreotide as an ... Another meta-analysis consisting of over 2000 patients concluded that octreotide was the safest vasoactive drug, with the lowest risk of adverse ...