Uncovered Transjugular Intrahepatic Portosystemic Shunt for Refractory Ascites: A Meta-Analysis
2005; Elsevier BV; Volume: 129; Issue: 4 Linguagem: Inglês
10.1053/j.gastro.2005.07.031
ISSN1528-0012
AutoresGennaro D’Amico, Angelo Luca, Alberto Morabito, Roberto Miraglia, Mario D’amico,
Tópico(s)Organ Transplantation Techniques and Outcomes
ResumoBackground & Aims: Several trials showed that uncovered transjugular intrahepatic portosystemic shunt (TIPS) is superior to paracentesis for the control of refractory ascites. However, the results for encephalopathy and mortality were not consistent across trials. We performed a systematic review of randomized controlled trials of TIPS for refractory ascites to assess the overall treatment effects and to explore potential reasons of heterogeneity. Methods: Pertinent studies were retrieved trough MEDLINE (1968–2004), EMBASE (1986–2004), the Cochrane Library (2004;4), and reference lists of key articles. Outcome measures were recurrence of ascites, encephalopathy, and mortality. Metaregression analysis was used to explore heterogeneity. Results: Five trials were identified including 330 patients. Successful TIPS placement ranged from 77% to 100% and portosystemic pressure gradient reduction ranged from 6.0 to 14.0 mm Hg. Metaregression analysis showed that bilirubin levels and successful TIPS placement rates were associated significantly with log–odds ratio for death after TIPS, explained heterogeneity of trials for mortality, and suggested an outlier trial. After exclusion of the outlier trial, pooled odds ratios for recurrence of ascites with TIPS was .14 (confidence interval, .07–.27), for encephalopathy was 2.26 (confidence interval, 1.35–3.76), and for mortality was .74 (confidence interval, .40–1.37), without any significant heterogeneity. Conclusions: Uncovered TIPS is significantly better than paracentesis for control of refractory ascites. Although it increases encephalopathy, it also is associated with a trend toward improvement of survival. Future TIPS trials should select patients on the basis of bilirubin levels and predictors of the risk for post-TIPS encephalopathy, and assess costs and quality of life. Background & Aims: Several trials showed that uncovered transjugular intrahepatic portosystemic shunt (TIPS) is superior to paracentesis for the control of refractory ascites. However, the results for encephalopathy and mortality were not consistent across trials. We performed a systematic review of randomized controlled trials of TIPS for refractory ascites to assess the overall treatment effects and to explore potential reasons of heterogeneity. Methods: Pertinent studies were retrieved trough MEDLINE (1968–2004), EMBASE (1986–2004), the Cochrane Library (2004;4), and reference lists of key articles. Outcome measures were recurrence of ascites, encephalopathy, and mortality. Metaregression analysis was used to explore heterogeneity. Results: Five trials were identified including 330 patients. Successful TIPS placement ranged from 77% to 100% and portosystemic pressure gradient reduction ranged from 6.0 to 14.0 mm Hg. Metaregression analysis showed that bilirubin levels and successful TIPS placement rates were associated significantly with log–odds ratio for death after TIPS, explained heterogeneity of trials for mortality, and suggested an outlier trial. After exclusion of the outlier trial, pooled odds ratios for recurrence of ascites with TIPS was .14 (confidence interval, .07–.27), for encephalopathy was 2.26 (confidence interval, 1.35–3.76), and for mortality was .74 (confidence interval, .40–1.37), without any significant heterogeneity. Conclusions: Uncovered TIPS is significantly better than paracentesis for control of refractory ascites. Although it increases encephalopathy, it also is associated with a trend toward improvement of survival. Future TIPS trials should select patients on the basis of bilirubin levels and predictors of the risk for post-TIPS encephalopathy, and assess costs and quality of life. Refractory ascites is a serious complication of portal hypertension in patients with advanced cirrhosis.1Arroyo V. Colmenero J. Ascites and hepatorenal syndrome in cirrhosis pathophysiological basis of therapy and current management.J Hepatol. 2003; 38: S69-S89Abstract Full Text Full Text PDF PubMed Google Scholar It is associated with an increased risk of hepatorenal syndrome and spontaneous bacterial peritonitis.2Bosch J. Garcia-Pagan J.C. Complications of cirrhosis. I. Portal hypertension.J Hepatol. 2000; 32: 141-146Abstract Full Text PDF PubMed Scopus (431) Google Scholar, 3Gines P. Guevara M. Arroyo V. Rodes J. Hepatorenal syndrome.Lancet. 2003; 362: 1819-1827Abstract Full Text Full Text PDF PubMed Scopus (529) Google Scholar, 4Moller S. Henriksen H. Review article pathogenesis and pathophysiology of hepatorenal syndrome—is there a scope for prevention?.Aliment Pharmacol Ther. 2004; 20: 31-41Crossref PubMed Scopus (41) Google Scholar One-year mortality rates range from 20% to 50%5Runyon B.A. Refractory ascites.Semin Liver Dis. 1993; 13: 343-351Crossref PubMed Scopus (35) Google Scholar, 6Russo M.W. Sood A. Jacobson I.M. Brown Jr, S.R. Transjugular intrahepatic portosystemic shunt for refractory ascites an analysis of the literature on efficacy, morbidity and mortality.Am J Gastroenterol. 2003; 98: 2521-2527Crossref PubMed Scopus (63) Google Scholar and liver transplantation is the only definitive treatment for most patients. In these patients, repeated large-volume or total paracentesis associated with intravenous albumin infusion is considered the first-line treatment. Although paracentesis is effective and safe in the elimination of ascites, it does not correct portal hypertension and neither prevents recurrence of ascites nor modifies the natural course of the disease. Surgical portal-caval shunts reducing portal pressure are effective in the treatment of refractory ascites but they have been abandoned because of their high morbidity and mortality rates. Transjugular intrahepatic portosystemic shunt (TIPS), which physiologically is equivalent to a side-to-side portal caval shunt, has been proposed for the treatment of refractory ascites7Ochs A. Rossle M. Haag K. Hauenstein K.H. Deibert P. Siegerstetter V. Huonker M. Langer M. Blum H.E. The transjugular intrahepatic portosystemic stent-shunt procedure for refractory ascites.N Engl J Med. 1995; 332: 1192-1197Crossref PubMed Scopus (440) Google Scholar, 8Quiroga J. Sangro B. Nuñez M. Bilbao I. Longo J. Garcia-Villarreal L. 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Transjugular intrahepatic portosystemic shunt for refractory ascites an analysis of the literature on efficacy, morbidity and mortality.Am J Gastroenterol. 2003; 98: 2521-2527Crossref PubMed Scopus (63) Google Scholar However, the available randomized controlled trials (RCTs) comparing TIPS with repeat paracentesis show conflicting results that hinder conclusions for clinical practice.10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google Scholar, 11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google Scholar, 12Gines P. Uriz J. 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Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google Scholar included a very small number of patients and showed a higher mortality rate in the TIPS than in the control group in Child–Pugh15Pugh R.N. Murray-Lyon I.M. Dawson J.L. Pietrni M.C. Williams R. Transection of the esophagus for bleeding oesophageal varices.Br J Surg. 1973; 60: 646-649Crossref PubMed Scopus (7089) Google Scholar class C patients. In a larger study including 60 patients,11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google Scholar a multivariate analysis showed that TIPS was associated independently with better survival by adjusting the treatment effect for bilirubin levels, age, sex, and serum sodium levels. Two other subsequent RCTs12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google Scholar, 13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google Scholar failed to show any difference in survival and the most recent RCT14Salerno F. Merli M. Riggio O. Cazzaniga M. Valeriano V. Pozzi M. Nicolini A. Salvatori F. GISTRandomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.Hepatology. 2004; 40: 629-635Crossref PubMed Scopus (315) Google Scholar showed improved survival with TIPS. In fact, a recent Cochrane meta-analysis,16Saab S. Nieto J.M. Ly D. Runyon B.A. TIPS versus paracentesis for cirrhotic patients with refractory ascites.Cochrane Database Syst Rev. 2004; 3: CD004889PubMed Google Scholar including the first 4 of these RCTs,10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google Scholar, 11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google Scholar, 12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google Scholar, 13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google Scholar found a statistically significant and yet unexplained heterogeneity for the TIPS effect on mortality. The aim of this meta-analysis was to assess the efficacy of TIPS compared with large-volume or total paracentesis in cirrhotic patients with refractory ascites including all 5 RCTs now available and, where appropriate, to explore the causes of heterogeneity. Eligible RCTs were those comparing TIPS with large-volume or total paracentesis (± intravenous albumin infusion) for refractory ascites in patients with cirrhosis regardless of the cause of liver disease, irrespective of publication status or language. Quasirandomized trials and observational studies were excluded. Measures of treatment efficacy were as follows: (1) recurrence of ascites requiring paracentesis: number of patients in whom a new paracentesis was needed after the trial treatment; (2) portosystemic encephalopathy: number of patients with encephalopathy after the trial treatment independent of portosystemic encephalopathy prevalence at randomization and the number of patients developing grades III/IV encephalopathy according to Conn and Liebertal17Conn H.O. Liebertal M.M. The hepatic coma syndromes and lactulose. Williams & Wilkins, Baltimore1979Google Scholar or an equivalent classification; (3) mortality: the number of patients who died during the study period, the number of patients who died of gastrointestinal bleeding, and the number of patients who died of causes other than bleeding. Adverse events associated with treatment, the number of patients crossed-over between treatment groups, and the number of patients undergoing liver transplantation also were assessed. Retrieval of RCTs was based on the Cochrane Controlled Trials Register, The Cochrane Library, MEDLINE, and ENBASE (until December 2004) using the terms TIPS, paracentesis, and refractory ascites, and limiting the search to randomized clinical trials and human studies. A manual search also was performed using the reference lists from articles, reviews, editorials, and the proceedings of international congresses. When the results of a single study were reported in more than 1 publication, only the most recent and complete data were included in the meta-analysis. Decisions on which trials to include were taken unblindly by 2 reviewers (A.L. and G.D.). Disagreements were resolved by discussion. Excluded trials were identified with the reason for exclusion. Five RCTs fulfilled the inclusion criteria, all published as full reports.10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google Scholar, 11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google Scholar, 12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google Scholar, 13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google Scholar, 14Salerno F. Merli M. Riggio O. Cazzaniga M. Valeriano V. Pozzi M. Nicolini A. Salvatori F. GISTRandomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.Hepatology. 2004; 40: 629-635Crossref PubMed Scopus (315) Google Scholar The methodologic quality of the trials was assessed by 4 major criteria previously validated18Jadad A.R. Moore R.A. Carroll D. Jenkinson C. Reynolds J.M. Gavaghan D.J. McQuay D.M. Assessing the quality of reports of randomized clinical trials is blinding necessary?.Control Clin Trials. 1996; 17: 1-12Abstract Full Text PDF PubMed Scopus (14223) Google Scholar, 19Moher D. Pham B. Jones A. Cook D.J. Jadad A.R. 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Allocation concealment in randomised trials defending against deciphering.Lancet. 2002; 359: 614-618Abstract Full Text Full Text PDF PubMed Scopus (678) Google Scholar, 24Schultz K.F. Grimes A.D. Blinding in randomised trials.Lancet. 2002; 359: 696-700Abstract Full Text Full Text PDF PubMed Scopus (656) Google Scholar: adequate generation of the randomization sequence, adequate treatment allocation concealment, blinded outcome assessment, and intention-to-treat analysis. Each quality component was rated as yes, unclear, or no. The quality of trials was reported according to each separate component.20Juni P. Altman D.G. Egger M. Assessing the quality of controlled clinical trials.BMJ. 2001; 323: 42-46Crossref PubMed Scopus (2352) Google Scholar Data concerning trials, patient characteristics, and treatment outcome (Table 1, Table 2, Table 3, Table 4, Table 5, Table 6, Table 7) were abstracted by 3 independent reviewers (G.D., A.L., and R.M.) and discrepancies were resolved by discussion.Table 1Study Characteristics of Each RCT Included in the Meta-AnalysisStudy characteristicsLebrec et al10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google ScholarRossle et al11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google ScholarGines et al12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google ScholarSanyal et al13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google ScholarSalerno et al14Salerno F. Merli M. Riggio O. Cazzaniga M. Valeriano V. Pozzi M. Nicolini A. Salvatori F. GISTRandomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.Hepatology. 2004; 40: 629-635Crossref PubMed Scopus (315) Google ScholarExperimental treatmentTIPS: balloon-expandable Palmaz stentaPalmaz stent P308, Johnson & Johnson Interventional Systems, Chatenay-Malabry, France.TIPS: balloon-expandable Palmaz or self-expandable nitinol stentbPalmaz-Schatz, Johnson and Johnson Interventional Systems, Warren, NJ.TIPS: balloon-expandable WallstentdWallstent; Schneider, Minneapolis, MN.TIPS: type NRTIPS: balloon-expandable WallstentdWallstent; Schneider, Minneapolis, MN. or MemothermcMemotherm, Bard-Angiomed, Karlsruhe, Germany.Control treatmentType of paracentesisLarge volumeLarge volumeTotalTotalLarge volumeAlbumin infusion (g/L of paracentesis)NR8eWhen clinically indicated.86–88Type of participantsCirrhotic patients with refractory ascitesCirrhotic patients with refractory or recurrent ascitesCirrhotic patients with refractory ascitesCirrhotic patients with refractory ascitesCirrhotic patients with refractory or recurrent ascitesExclusion criteriaAge >70, PSE >grade I, PVT, HCC, creatinine >1.7 mg/dLPSE >grade I, bilirubin >5 mg/dL, PVT, HCC, creatinine >3 mg/dLAge 75, PSE >grade I, PVT, HCC, bilirubin >10 mg/dL, creatinine >3 mg/dL prothrombin <40%, platelets grade I, PVT, bilirubin >5 mg/dL, creatinine ≥1.5 mg/dL, HCC, parenchymal renal disease, UGIB within 6 weeksAge >72, PSE >grade II, bilirubin >6 mg/dL, creatinine >3 mg/dL, PVT, HCC, Child–Pugh score >11, UGIB within 3 weeksOutcomesRecurrence of ascites, PSE, mortalityRecurrence of ascites, PSE, mortality, and/or liver transplantRecurrence of ascites, PSE, UGIB, SBP, mortality, and/or liver transplantRecurrence of ascites requiring paracentesis, PSE, variceal bleeding, HRS, mortality and/or liver transplantRecurrence of ascites, PSE, mortalityNumber of patients screenedNR155119525137Number of patients randomized25607010966Number of participating centers12463Number of patients per center25NRNR7/11/12/21/22/3632/24/10Number of patients lost to follow-up evaluationNR01NR2MethodGeneration of the randomization listNRNRNRNRNRConcealment of treatment assignmentSealed opaque envelopesNRSealed opaque envelopesNRSealed opaque envelopesOutcome assessmentUnblindedUnblindedUnblindedUnblindedUnblindedIntention-to-treat analysisYesYesYesYesYesTIPS patency surveillanceDoppler sonographyDoppler sonographyHepatic vein catheterization if ascites recurredAngiographyDoppler sonographyMean follow-up period (TIPS/P)7.5/12.4fEstimated from the survival curve.45/449.5/10.841/3821/15Publication statusFull reportFull reportFull reportFull reportFull reportYear of publication19962000200220032004PA, paracentesis; NR, not reported; PSE, portosystemic encephalopathy; PVT, portal vein thrombosis; HCC, hepatocellular carcinoma; UGIB, upper gastrointestinal bleeding; SBP, spontaneous bacterial peritonitis; HRS, hepatorenal syndrome.a Palmaz stent P308, Johnson & Johnson Interventional Systems, Chatenay-Malabry, France.b Palmaz-Schatz, Johnson and Johnson Interventional Systems, Warren, NJ.c Memotherm, Bard-Angiomed, Karlsruhe, Germany.d Wallstent; Schneider, Minneapolis, MN.e When clinically indicated.f Estimated from the survival curve. Open table in a new tab Table 2Characteristics of Patients Included in Each RCT Using TIPS/Paracentesis Included in the Meta-AnalysisPatient characteristicsLebrec et al10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google ScholaraPlus-minus values are mean ± SEM.Rossle et al11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google ScholarbPlus-minus values are mean ± SD.Gines et al12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google ScholaraPlus-minus values are mean ± SEM.Sanyal et al13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google ScholarcNot reported whether plus-minus values are SEM or SD, although they most likely are SD.Salerno et al14Salerno F. Merli M. Riggio O. Cazzaniga M. Valeriano V. Pozzi M. Nicolini A. Salvatori F. GISTRandomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.Hepatology. 2004; 40: 629-635Crossref PubMed Scopus (315) Google ScholaraPlus-minus values are mean ± SEM.Number randomized13/1229/3135/3552/5733/33Percentage refractory ascites100/10058/52100/100100/10072/64Age, y (mean)50/5258/6159/5656/5258/60Percentage men77/6672/6869/7463/7072/76Percentage alcohol-induced cirrhosis77/8383/7451/6062/5845/39Percentage Child–Pugh class C31/3338/2337/43NR79/73Mean Child–Pugh score9.3/9.29.1/8.79.3/9.29.2/9.39.4/9.4Percentage encephalopathy15/1746/3937/40NR27/21Percentage with previous gastrointestinal or variceal bleedsNRNR34/2323/2518/21Serum bilirubin, mg/dL2.04 ± .5/1.57 ± .21.8 ± 1.2/1.8 ± 1.02.0 ± .2/2.4 ± .31.9 ± 1.2/1.9 ± 1.41.7 ± .15/1.9 ± .24Serum albumin, g/dL3.0 ± .1/3.1 ± .23.5 ± .6/3.5 ± .42.8 ± .1/3.0 ± .12.9 ± .4/2.7 ± .42.9 ± .7/2.9 ± .8Serum creatinine, mg/dL.9 ± .7/.9 ± .61.3 ± .4/1.4 ± .91.4 ± .1/1.4 ± .11.1 ± .3/1.0 ± .31.12 ± .06/1.15 ± .09Serum sodium, mmol/L130 ± 2/130 ± 2130 ± 6/131 ± 6129 ± 1/130 ± 1NR133 ± 1/133 ± 1Percentage hyponatremiaNR17/1354/48NR21/24Urine sodium, mmol/day (mean ± SD)<5/<545 ± 61/61 ± 529 ± 2/7 ± 2NR38 ± 6/38 ± 6NOTE. Data refer to TIPS/paracentesis.a Plus-minus values are mean ± SEM.b Plus-minus values are mean ± SD.c Not reported whether plus-minus values are SEM or SD, although they most likely are SD. Open table in a new tab Table 3Outcome Definitions Used in the Studies Included in this Meta-AnalysisDefinitionsLebrec et al10Lebrec D. Giuily N. Hadengue A. Vilgrain V. Moreau R. Poynard T. Gadano A. et al.Transjugular intrahepatic portosystemic shunts: comparison with paracentesis in patients with cirrhosis and refractory ascites: a randomized trial.J Hepatol. 1996; 25: 135-144Abstract Full Text PDF PubMed Scopus (399) Google ScholarRossle et al11Rossle M. Ochs A. Gulberg V. Siegerstetter V. Holl J. Deibert P. Olschewski M. et al.A comparison of paracentesis and transjugular intrahepatic portosystemic shunting in patients with ascites.N Engl J Med. 2000; 342: 1701-1707Crossref PubMed Scopus (511) Google ScholarGines et al12Gines P. Uriz J. Calahorra B. Garcia-Tsao G. Kamath P.S. Del Arbol L.R. Planas R. et al.Transjugular intrahepatic portosystemic shunting versus paracentesis plus albumin for refractory ascites in cirrhosis.Gastroenterology. 2002; 123: 1839-1847Abstract Full Text Full Text PDF PubMed Scopus (475) Google ScholarSanyal et al13Sanyal A.J. Genning C. Reddy K.R. Wong F. Kowdley K.V. Benner K. McCashland T. et al.The North American Study for the Treatment of Refractory Ascites.Gastroenterology. 2003; 124: 634-641Abstract Full Text Full Text PDF PubMed Scopus (372) Google ScholarSalerno et al14Salerno F. Merli M. Riggio O. Cazzaniga M. Valeriano V. Pozzi M. Nicolini A. Salvatori F. GISTRandomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites.Hepatology. 2004; 40: 629-635Crossref PubMed Scopus (315) Google ScholarRefractory ascitesNo responseaNo response: mean loss of body weight of <200 g/day for 5 days. to low sodium diet and spironolactone up to 300 mg/day plus furosemide up to 120 mg/day48Ginès P. Arroyo V. Vargas B. Planas R. Casafont F. Panés J. Hoyos M. et al.Paracentesis with intravenous infusion of albumin as compared with peritoneovenous shunting in cirrhosis with refractory ascites.N Engl J Med. 1991; 325: 829-835Crossref PubMed Scopus (300) Google ScholarNo response to a 4-week low-sodium diet and spironolactone up to 400 mg/day plus furosemide up to 120 mg/day49Arroyo V. Ginès P. Gerbes A.L. Dudley J.F. Gentilini P. Laffi G. Reynolds T.B. et al.Definitions and diagnostic criteria of refractory ascites and hepatorenal syndrome in cirrhosis.Hepatology. 1996; 23: 164-176Crossref PubMed Google ScholarNo responsebNo response: mean loss of weight <200 g/day during the last 4 days of intensive diuretic therapy and urinary sodium excretion less than 50 mEq/day.49 to low sodium diet and spironolactone up to 400 mg/day plus furosemide up to 160 mg/day48Ginès P. Arroyo V. Vargas B. Planas R. Casafont F. Panés J. Hoyos M. et al.Paracentesis with intravenous infusion of albumin as compared with peritoneovenous shunting in cirrhosis with refractory ascites.N Engl J Med. 1991; 325: 829-835Crossref PubMed Scopus (300) Google Scholar<1.5 kg/wk weight loss with furosemide (up to 160 mg/day) and spironolactone (up to 400 mg/day)49Arroyo V. Ginès P. Gerbes A.L. Dudley J.F. Gentilini P. Laffi G. Reynolds T.B. et al.Definitions and diagnostic criteria of refractory ascites and hepatorenal syndrome in cirrhosis.Hepatology. 1996; 23: 164-176Crossref PubMed Google ScholarNo responsebNo response: mean loss of weight <200 g/day during the last 4 days of intensive diuretic therapy and urinary sodium excretion less than 50 mEq/day.49 to low-sodium diet and spironolactone up to 400 mg/day and furosemide up to 160 mg/day49Arroyo V. Ginès P. Gerbes A.L. Dudley J.F. Gentilini P. Laffi G. Reynolds T.B. et al.Definitions and diagnostic criteria of refractory ascites and hepatorenal syndrome in cirrhosis.Hepatology. 1996; 23: 164-176Crossref Pub
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