Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis

Study Overview
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Brief Summary
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Octreotide is used to control variceal bleeding. However, octreotide has to be given through the vein and is effective for less than two hours. In this study the investigators determined whether a long-acting preparation of octreotide (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.

Official Title
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Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis Hepatic Hemodynamic Responses to Long-acting Octreotide in Patients With Cirrhosis

Conditions
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Cirrhosis, Portal Hypertension, Esophageal Varices

Intervention / Treatment
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* Drug: Long acting octreotide 10mg
* Drug: Long acting Octreotide 30mg
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis documented by biopsy, or suggested by characteristic features on abdominal imaging (nodular appearance, irregular contour) along with impaired synthetic liver function and thrombocytopenia and Child Turcotte Pugh Class A or B. presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment age ≥ 18 years Exclusion Criteria: pregnant, lactating or of child-bearing potential and not practicing acceptable method of birth control allergic to sandostatin high risk varices on endoscopy carried out within 3 months of assessment (large varices or red signs) Child Turcotte Pugh Class C cirrhosis hepatocellular carcinoma evidence of ongoing alcohol or illicit drug abuse within 6 months of the study serum creatinine greater than 2 mg/dL platelet count below 50,000 per microliter prothrombin time 4 seconds or more greater than control human immunodeficiency virus (HIV) positive symptomatic gallstones previous history of upper gastrointestinal bleeding in the past 3 months, defined as hematemesis and/or melena previous history of variceal bleeding history of congestive heart failure , unstable angina, sustained ventricular tachycardia, or ventricular fibrillation use of any investigational drug within 1 month prior to screening and current use of beta blockers or long-acting nitrates, any other drug therapy known to have an influence on portal pressure (diuretics were allowed provided patients were on a stable dose for at least 30 days).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sandostatin LAR 10mg<br>Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg | Drug: Long acting octreotide 10mg<br>* Comparison of different doses<br>* Other names: Long-acting octreotide;|
| Experimental: Sandostatin LAR 30mg<br>Comparison of drug doses | Drug: Long acting Octreotide 30mg<br>* Comparison of drug doses<br>|
| Placebo Comparator: Saline<br>Saline control | Drug: Saline<br>* Comparison of drug doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portal hypertension, varices, cirrhosis, octreotide, somatostatin analog, Child Pugh Class A,B