What side effects are associated with this type of intervention?

Common treatments for esophageal varices include somatostatin analogs like octreotide. Known side effects of octreotide include gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhea. Other potential side effects are hyperglycemia, gallstones, and injection site reactions. These treatments aim to reduce gastrointestinal blood flow and hormone secretion, thereby managing variceal bleeding effectively.

What prior FDA approvals exist?

Octreotide, a somatostatin analog, has been studied for its efficacy in treating esophageal varices by reducing gastrointestinal blood flow and hormone secretion. It has shown to be effective in controlling variceal bleeding and is well-tolerated compared to other treatments like esophageal tamponade. Other somatostatin analogs, such as lanreotide and pasireotide, have also been explored for similar uses, although they are more commonly associated with treating conditions like polycystic liver disease and neuroendocrine tumors. These treatments are valuable adjuncts to endoscopic management in controlling acute gastrointestinal hemorrhage caused by ruptured esophageal varices.

What other types of research exist?

One promising alternative to Octreotide for esophageal varices is the use of non-selective beta-blockers (NSBBs) such as carvedilol. NSBBs have been shown to reduce portal hypertension, which is a key factor in the development of esophageal varices. Another potential alternative is the use of vasoactive drugs like terlipressin, which can reduce portal pressure and control variceal bleeding. Additionally, endoscopic variceal ligation (EVL) remains a highly effective non-pharmacological treatment option. These alternatives have been evaluated in clinical settings and offer potential benefits for patients with esophageal varices.

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Somatostatin Analog

Octreotide Infusion Duration for Esophageal Varices (LOVARB Trial)

Phase 4

Recruiting

Led By Don Rockey, M.D

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence or suspicion of upper gastrointestinal bleed (GIB)

Upper GIB secondary to bleeding esophageal varices as shown by esophageal endoscopy, requiring endoscopic band ligation (EBL) at presentation

Must not have

Bleeding from gastric varices, with or without esophageal varices

Use of any other endoscopic method to stop GI bleeding beyond endoscopic band ligation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days and 30 days

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Octreotide may cause side effects such as abdominal pain, nausea, diarrhea or constipation, flatulence (gas), headache, dizziness or fatigue. Some people might experience injection site reactions like redness or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I might have bleeding in my upper digestive tract.

Select...

I have had bleeding in my upper digestive tract due to swollen veins in my esophagus, treated with a specific procedure.

Select...

I have or might have cirrhosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have bleeding from stomach veins.

Select...

I have used methods other than band ligation to stop GI bleeding.

Select...

I have been diagnosed with cancer in my upper digestive system.

Select...

I have had surgery to improve blood flow in my liver.

Select...

I have high blood pressure in the veins of my esophagus, but I don't have cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days and 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days and 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Esophageal varices rebleed within 72-hours after control of initial bleed

Secondary study objectives

Esophageal varices rebleed at 7 days and 30 days after control of initial bleed

Survival at 7 days and 30 days after control of initial bleed

Side effects data

From 2013 Phase 3 trial • 429 Patients • NCT00412061

53%

Diarrhoea

51%

Stomatitis

48%

Fatigue

43%

Nausea

43%

Oedema peripheral

41%

Rash

32%

Vomiting

30%

Abdominal pain

30%

Decreased appetite

30%

Headache

27%

Anaemia

27%

Weight decreased

27%

Cough

27%

Dyspnoea

24%

Asthenia

23%

Hypokalaemia

20%

Pyrexia

20%

Dysgeusia

20%

Pruritus

20%

Hyperglycaemia

18%

Arthralgia

16%

Thrombocytopenia

15%

Back pain

15%

Pain in extremity

15%

Epistaxis

14%

Constipation

13%

Dizziness

13%

Aphthous stomatitis

13%

Flatulence

13%

Upper respiratory tract infection

13%

Urinary tract infection

11%

Dry skin

11%

Hypertension

10%

Musculoskeletal pain

10%

Abdominal pain upper

10%

Dry mouth

Pneumonitis

Oropharyngeal pain

Nasopharyngitis

Insomnia

Flushing

Neutropenia

Dehydration

Ascites

Haemorrhoids

Mouth ulceration

Muscle spasms

Musculoskeletal chest pain

Erythema

Hypercholesterolaemia

Hypocalcaemia

Chills

Blood creatinine increased

Leukopenia

Hypomagnesaemia

Myalgia

Dysphagia

Anxiety

Depression

Hyperlipidaemia

Pleural effusion

Abdominal distension

Alopecia

Sinusitis

Dysuria

Hypophosphataemia

Pollakiuria

Aspartate aminotransferase increased

Bronchitis

Onychoclasis

Alanine aminotransferase increased

Hyperhidrosis

Small intestinal obstruction

Pneumonia

Dyspnoea exertional

Pulmonary embolism

General physical health deterioration

Ileus

Renal failure

Hypoglycaemia

Carcinoid heart disease

Flank pain

Colitis

Angina pectoris

Small intestinal stenosis

Gastroenteritis

Atrial septal defect

Cholecystitis acute

Bone pain

Subileus

Cardiac failure

Cardiac failure congestive

Carcinoid syndrome

Abdominal pain lower

Rectal haemorrhage

Malaise

Non-cardiac chest pain

Cachexia

Hypoxia

Interstitial lung disease

Syncope

Renal failure acute

Intestinal obstruction

Cellulitis

Hepatic failure

Sepsis

Metabolic acidosis

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + Octreotide

Everolimus + Octreotide

Everolimus Open Label

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Octreotide

2006

Completed Phase 4

~2360

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for esophageal varices include somatostatin analogs like octreotide, endoscopic variceal ligation (EVL), and beta-blockers. Octreotide works by reducing gastrointestinal blood flow and hormone secretion, which helps to decrease the pressure in the varices and reduce the risk of bleeding. EVL involves the placement of rubber bands around the varices to physically obstruct blood flow and prevent rupture. Beta-blockers lower portal hypertension by decreasing cardiac output and dilating blood vessels, which also reduces the risk of variceal bleeding. These treatments are crucial for managing esophageal varices because they directly address the high risk of life-threatening hemorrhage associated with this condition.

[Octreotide in the treatment of acute gastrointestinal hemorrhage caused by ruptured esophageal varices].