title: Randomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.
abstract: The transjugular intrahepatic portosystemic shunt (TIPS) has been shown to be effective in the control of refractory or recidivant ascites. However, the effect of TIPS on survival as compared with that of large-volume paracentesis plus albumin is uncertain. A multicenter, prospective, clinical trial was performed in 66 patients with cirrhosis and refractory or recidivant ascites (16 Child-Turcotte-Pugh class B and 50 Child-Turcotte-Pugh class C) randomly assigned to treatment with TIPS (n = 33) or with large-volume paracentesis plus human albumin (n = 33). The primary endpoint was survival without liver transplantation. Secondary endpoints were treatment failure, rehospitalization, and occurrence of complications. Thirteen patients treated with TIPS and 20 patients treated with paracentesis died during the study period, 4 patients in each group underwent liver transplantation. The probability of survival without transplantation was 77% at 1 year and 59% at 2 years in the TIPS group as compared with 52% and 29% in the paracentesis group (P = .021). In a multivariate analysis, treatment with paracentesis and higher MELD score showed to independently predict death. Treatment failure was more frequent in patients assigned to paracentesis, whereas severe episodes of hepatic encephalopathy occurred more frequently in patients assigned to TIPS. The number and duration of rehospitalizations were similar in the two groups. In conclusion, compared to large-volume paracentesis plus albumin, TIPS improves survival without liver transplantation in patients with refractory or recidivant ascites.
authors.affiliation: Department of Internal Medicine, University and Ospedale Maggiore Policlinico Instituto di Ricerca e Cura a Carattere Scientifico (IRCCS), Milan, Italy. francesco.salerno@unimi.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Salerno
authors.forename: Manuela
authors.initials: M
authors.lastname: Merli
authors.forename: Oliviero
authors.initials: O
authors.lastname: Riggio
authors.forename: Massimo
authors.initials: M
authors.lastname: Cazzaniga
authors.forename: Valentina
authors.initials: V
authors.lastname: Valeriano
authors.forename: Massimo
authors.initials: M
authors.lastname: Pozzi
authors.forename: Antonio
authors.initials: A
authors.lastname: Nicolini
authors.forename: Filippo
authors.initials: F
authors.lastname: Salvatori
mesh_terms: D000418:Albumins / Q000627:therapeutic use*; D001201:Ascites / Q000401:mortality / Q000628:therapy*; D005260:Female; D006501:Hepatic Encephalopathy / Q000209:etiology; D006760:Hospitalization; D006801:Humans; D008103:Liver Cirrhosis / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019152:Paracentesis; D019168:Portasystemic Shunt, Transjugular Intrahepatic; D011446:Prospective Studies; D017211:Treatment Failure
chemical_list: D000418:Albumins