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

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Portal Hypertension; Esophageal Varices; Cirrhosis

Treatments: Drug: Long acting octreotide 10mg; Drug: Long acting Octreotide 30mg; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01188733

10-005739

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. presence of small esophageal varices, defined as varices < 5 mm in diameter, without red signs documented on endoscopy within 3 months of enrollment
3. 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).

Trial design

39 participants in 3 patient groups, including a placebo group

Sandostatin LAR 10mg

Experimental group

Description:

Sandostatin LAR ( long-acting octreotide) administered every 28 days in a dose of 10mg

Treatment:

Drug: Long acting octreotide 10mg

Sandostatin LAR 30mg

Experimental group

Description:

Comparison of drug doses

Treatment:

Drug: Long acting Octreotide 30mg

Saline

Placebo Comparator group

Description:

Saline control

Treatment:

Drug: Saline