Bleeding from large veins in the esophagus (esophageal varices) occurs in about 1/3 of patients with cirrhosis and can be life threatening. Medications called beta-blockers are currently given to patients with large veins in the esophagus to drop the pressure in the vein and decrease the chance of bleeding, but about half of patients do not take them because of contraindications, poor tolerance or difficulties with compliance. Octreotide is a short acting medication widely used in the short run to stop bleeding from varices, once it has occurred. It works by blunting the rise in pressure in these veins, which occurs after meals. A newly developed, long-acting release preparation of octreotide, Sandostatin LAR, may be effective for long-term use to prevent bleeding from varices. This study is intended to determine the safety of Sandostatin LAR and its effect on blood flow and pressure in the veins supplying the varices after a meal in 24 cirrhotic patients. Persons who participate in this study will receive a test dose of octreotide and have blood drawn over 24 hours to determine their tolerance and the levels of the drug in the blood. They will then be randomly assigned to receive 10mg, or 30 mg Sandostatin LAR or an inactive placebo (salt water) every 4 weeks for 3 injections. Blood samples drawn before the test medication is given (Sandostatin LAR or placebo), at 14 days, prior to the second (day 28) and third injections (day 56) and 28 days after the third injection (day 84) will be used to determine the blood levels of the LAR preparation. Blood flow in the veins supplying the varices will be determined by ultrasound (sonar) before and after a test meal before the test medication is given and on days 28, 56 and 84 after initiation of Sandostatin LAR. In addition, pressure in the veins supplying the varices will be measured both before and after meals using a small tube that enters a vein in the neck and is passed into the veins draining the liver. This will be done before the study medicine is given and on day 84, 28 days after the last dose of study medication.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000334-35
Application #
6418949
Study Section
Special Emphasis Panel (ZRR1)
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
35
Fiscal Year
2001
Total Cost
Indirect Cost
Name
Oregon Health and Science University
Department
Type
DUNS #
009584210
City
Portland
State
OR
Country
United States
Zip Code
97239
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