TRANSJUGULAR PORTASYSTEMIC SHUNTS/PARACENTESIS FOR TREATMENT OF ASCITES

Virginia Commonwealth University, Richmond VA

Investigators

Linked publications & trials

Abstract

A trial to determine if the relatively new procedure called transjugular intrahepatic portosystemic shunt (TIPS) can treat fluid build up in patients who have had cirrhosis and increased pressure in the veins supplying blood to the liver. Cirrhosis effects 3.6 out of every 100 North American adults and is responsible for the loss of 10.6 million work days and 32,000 deaths annually. Fluid retention is the most common complication of cirrhosis and developes in over 60% of patients. There is a need to develop a better treatment for this problem. Fluid build up is a common complication of cirrhosis of the liver. The worsening of symptoms is often complicated by the development of resistence to diuretics (water pills), or complications limiting the use of diuretics. This fluid retention, which does not respond to treatment, is associated with discomfort, difficulty breathing, malnutrition, liver and kidney failure, and death or increased risk of death following liver transplantation. Paracentesis (repeated removal of large amounts of fluid by piercing the organ) or total removal of the fluid along with intravenous administration of albumin are the most commonly used therapies for this problem. Neither of these therapies addresses the problem causing the water retention and may cause the recurrence of retention. Neither therapy has been shown to improve the survival of patients. TIPS is the insertion of a by-pass into the vein system of the liver in order to help the flow of blood and prevent the build up of fluid in the abdomen and esophagus. TIPS avoids the risk of general anesthesia and major surgery and has been shown to resolve the fluid retention problem in most patients. Also, in some patients, the nutritional state and liver function improve, thereby making transplantation unnecessary. But, because all published studies have been done on a small number of patients, this study will directly compare TIPS with the current standard of care, the puncturing of organs. 72 patients with severe fluid retention will be seen at the General Clinical Research Center. There will be two groups with two different combinations of therapy. The patients will be seen 1,2,and 4 weeks after insertion of the shunt, and monthly for 12 months. Then they'll be seen every three months. Special diets will be assigned and lab tests will be done at every visit.