title: The North American Study for the Treatment of Refractory Ascites.
abstract: OBJECTIVE
  The clinical utility of transjugular intrahepatic portosystemic shunts (TIPS) vis-à-vis total paracentesis in the management of refractory ascites is unclear.
  
  
  METHODS
  A multicenter, prospective, randomized clinical trial was performed in which 109 subjects with refractory ascites were randomized to either medical therapy (sodium restriction, diuretics, and total paracentesis) (n = 57) or medical therapy plus TIPS (n = 52). The principal end points were recurrence of tense symptomatic ascites and mortality.
  
  
  RESULTS
  A technically adequate shunt was created in 49 of 52 subjects. TIPS plus medical therapy was significantly superior to medical therapy alone in preventing recurrence of ascites (P < 0.001). The total number of deaths in the 2 groups was identical (TIPS vs. medical therapy alone: 21 vs. 21). There were no significant differences in the 2 arms with respect to overall and transplant-free survival. There was a higher incidence of moderate to severe encephalopathy in the TIPS group (20 of 52 vs. 12 of 57; P = 0.058). There were no significant differences in the number of subjects who developed liver failure (7 vs. 3), variceal hemorrhage (5 vs. 8), or acute renal failure (3 vs. 2). There were also no significant differences between the 2 groups in the frequency of emergency-department visits, medically indicated hospitalizations, or quality of life.
  
  
  CONCLUSIONS
  Although TIPS plus medical therapy is superior to medical therapy alone for the control of ascites, it does not improve survival, affect hospitalization rates, or improve quality of life.
authors.affiliation: Department of Internal Medicine, Virginia Commonwealth University Health System, Richmond, Virginia, USA. ajsanyal@hsc.vcu.edu
authors.forename: Arun J
authors.initials: AJ
authors.lastname: Sanyal
authors.forename: Chris
authors.initials: C
authors.lastname: Genning
authors.forename: K Rajender
authors.initials: KR
authors.lastname: Reddy
authors.forename: Florence
authors.initials: F
authors.lastname: Wong
authors.forename: Kris V
authors.initials: KV
authors.lastname: Kowdley
authors.forename: Kent
authors.initials: K
authors.lastname: Benner
authors.forename: Timothy
authors.initials: T
authors.lastname: McCashland
mesh_terms: D001201:Ascites / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D006706:Homeostasis / Q000502:physiology; D006728:Hormones / Q000378:metabolism; D006801:Humans; D007668:Kidney / Q000503:physiopathology; D008099:Liver / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D019168:Portasystemic Shunt, Transjugular Intrahepatic / Q000009:adverse effects; D011788:Quality of Life; D012964:Sodium / Q000378:metabolism; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D006728:Hormones; D012964:Sodium