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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”



March 2003 (Volume 124, Number 3)

The North American Study for the Treatment of Refractory Ascites

Sanyal AJ, Genning C, Reddy KR, et al.
Gastroenterology. 2003;124(3):634-641

What is the clinical utility of transjugular intrahepatic portosystemic shunts (TIPS) vs total paracentesis (TP) in the treatment of patients with refractory ascites?

Ascites, the most common complication associated with cirrhosis, occurs in 50% of patients within 10 years of diagnosis of compensated cirrhosis. Development of ascites is a poor prognostic indicator, with a 50% 2-year survival, worsening significantly to 20% to 50% at 1 year when it becomes refractory to medical therapy.


Repeated large-volume paracentesis or TP currently represents the first-line approach to treatment of refractory ascites, but it is associated with recurrent ascites in most individuals and does not alter mortality. In this setting, TIPS has recently emerged as a potential alternative for the management of refractory ascites. This technique decompresses the portal vein and addresses the portal hypertension without necessitating general anesthesia or major surgery. However, there have been conflicting reports regarding efficacy of TIPS in the literature. Thus Sanyal and colleagues conducted an international, multicenter, prospective, randomized controlled trial (North American Study for Treatment of Refractory Ascites [NASTRA]) to compare the clinical utility of repeated TP, restriction of sodium, and treatment with diuretics (medical therapy arm) vs medical therapy plus TIPS (TIPS arm) in patients with cirrhosis and refractory ascites.

This study involved 109 patients with symptomatic, refractory ascites who were randomized to either the medical therapy arm (n = 57) or TIPS treatment arm (n = 52). Cirrhosis was established by either biopsy or abnormal liver function and a serum-to-ascites albumin gradient > 1.1. The primary study end points were recurrence of ascites requiring therapeutic TP and mortality.

Overall, results of this present study suggest that, although TIPS is substantially superior to conventional medical therapy alone in preventing recurrence of ascites (P < .001), this apparent efficacy does not correspond to improved survival or improved quality of life. Specifically, a technically adequate shunt was created in 49 of the 52 patients in the TIPS treatment arm. It was important to note that there were no differences in mortality between the 2 treatment arms; the total number of deaths in each group was 21. There were also no statistically significant differences between the 2 arms in terms of overall and transplant-free survival, occurrence of liver failure, variceal hemorrhage, acute renal failure, frequency of emergency department visits, or quality of life. The TIPS group did demonstrate a higher incidence of moderate-to-severe encephalopathy vs the medical therapy alone group (20 of 52 vs 12 of 57; P = .058).


Given that these study findings show a lack of improvement in survival, hospitalizations, and quality of life associated with TIPS treatment vs medical therapy alone, the use of the former as a first-line approach to managing a patient with refractory ascites should be guided by other factors. These other factors may include associated costs, presence of other complications of cirrhosis, candidacy for liver transplantation, etc. Thus these study authors conclude that, in general, TIPS should be considered a second-line approach to therapy for patients with refractory ascites or should be reserved for use as a bridge to liver transplantation.