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Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT01188733•Mayo Clinic

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

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
+6 more criteria

Key Dates

Start Date

June 1, 1998

Primary Completion Date

July 1, 2000

Completion Date

December 1, 2000

Last Updated

August 25, 2010

Enrollment

ACTUAL participants

Conditions

CirrhosisPortal HypertensionEsophageal Varices

Interventions

Long acting octreotide 10mg

DRUG

Long acting Octreotide 30mg

DRUG

Saline

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

NCT05597488

Cirrhosis Portal

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 25, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias

Mechanism of TIPS to Improve Sarcopenia

Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care