The North American study for the treatment of refractory ascites

Arun J. Sanyal, Chris Genning, K. Rajender Reddy, Florence Wong, Kris V. Kowdley, Kent Benner, Timothy M McCashland, Jaime Tisnado, Carol Sargeant, Velimir A. Luketic, Tom Scagnelli, Laurie Blendis, Kenneth Sniderman, Cynthia Natiello, John Borsa, Ken Flora, Robert Barron

Research output: Contribution to journalArticle

303 Citations (Scopus)

Abstract

Background & Aims: 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.

Original languageEnglish (US)
Pages (from-to)634-641
Number of pages8
JournalGastroenterology
Volume124
Issue number3
DOIs
StatePublished - Mar 1 2003

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Transjugular Intrahepatic Portasystemic Shunt
Ascites
Paracentesis
Therapeutics
Hospitalization
Quality of Life
Recurrence
Liver Failure
Brain Diseases
Diuretics
Acute Kidney Injury
Hospital Emergency Service
Arm
Randomized Controlled Trials
Sodium
Hemorrhage
Transplants
Mortality
Incidence

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Sanyal, A. J., Genning, C., Rajender Reddy, K., Wong, F., Kowdley, K. V., Benner, K., ... Barron, R. (2003). The North American study for the treatment of refractory ascites. Gastroenterology, 124(3), 634-641. https://doi.org/10.1053/gast.2003.50088

The North American study for the treatment of refractory ascites. / Sanyal, Arun J.; Genning, Chris; Rajender Reddy, K.; Wong, Florence; Kowdley, Kris V.; Benner, Kent; McCashland, Timothy M; Tisnado, Jaime; Sargeant, Carol; Luketic, Velimir A.; Scagnelli, Tom; Blendis, Laurie; Sniderman, Kenneth; Natiello, Cynthia; Borsa, John; Flora, Ken; Barron, Robert.

In: Gastroenterology, Vol. 124, No. 3, 01.03.2003, p. 634-641.

Research output: Contribution to journalArticle

Sanyal, AJ, Genning, C, Rajender Reddy, K, Wong, F, Kowdley, KV, Benner, K, McCashland, TM, Tisnado, J, Sargeant, C, Luketic, VA, Scagnelli, T, Blendis, L, Sniderman, K, Natiello, C, Borsa, J, Flora, K & Barron, R 2003, 'The North American study for the treatment of refractory ascites', Gastroenterology, vol. 124, no. 3, pp. 634-641. https://doi.org/10.1053/gast.2003.50088
Sanyal AJ, Genning C, Rajender Reddy K, Wong F, Kowdley KV, Benner K et al. The North American study for the treatment of refractory ascites. Gastroenterology. 2003 Mar 1;124(3):634-641. https://doi.org/10.1053/gast.2003.50088
Sanyal, Arun J. ; Genning, Chris ; Rajender Reddy, K. ; Wong, Florence ; Kowdley, Kris V. ; Benner, Kent ; McCashland, Timothy M ; Tisnado, Jaime ; Sargeant, Carol ; Luketic, Velimir A. ; Scagnelli, Tom ; Blendis, Laurie ; Sniderman, Kenneth ; Natiello, Cynthia ; Borsa, John ; Flora, Ken ; Barron, Robert. / The North American study for the treatment of refractory ascites. In: Gastroenterology. 2003 ; Vol. 124, No. 3. pp. 634-641.
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AU - Genning, Chris

AU - Rajender Reddy, K.

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AU - Kowdley, Kris V.

AU - Benner, Kent

AU - McCashland, Timothy M

AU - Tisnado, Jaime

AU - Sargeant, Carol

AU - Luketic, Velimir A.

AU - Scagnelli, Tom

AU - Blendis, Laurie

AU - Sniderman, Kenneth

AU - Natiello, Cynthia

AU - Borsa, John

AU - Flora, Ken

AU - Barron, Robert

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N2 - Background & Aims: 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.

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