Table 2.
Randomized controlled trials of TIPS vs. LVP as treatment for refractory ascites
| Study | No. of assessed/enrolled | Inclusion criteria | Exclusion criteria | Safety | Efficacy |
|---|---|---|---|---|---|
| Lebrec et al. [42] (1996) | 25/25 | Cirrhosis & RA defined as: no response to maximum diuretics for 5 days while in hospital, or ≥2 admissions for tense ascites in ≤4 months | Age >70 years | 1) HE: TIPS group, severe recurrent grade 3 HE in 2 patients, mild HE in 1 patient; LVP group, no HE | Minimum or no ascites at 4 months of all surviving patients: TIPS group, 5/6; paracentesis group, 1/10 |
| HE ≥ grade 2 | |||||
| PVT | |||||
| Biliary obstruction | |||||
| sCr >1.7 mg/dL | 2) Survival at 2 years: TIPS group, 29%±13%; paracentesis group, 60%±16% | ||||
| HCC | |||||
| Active bacterial infection | |||||
| Severe extra-hepatic disease | |||||
| Pulmonary hypertension | |||||
| Rössle et al. [43] (2000) | 150/60 | Cirrhosis & RA as defined by IAC criteria*: 55% | HE ≥ grade 2 | 1) HE at mean follow-up of approximately 44 months: TIPS group, 58%; LVP group, 48% | Complete response at 6 months: TIPS group, 79%; paracentesis group, 24% (P=0.001) |
| PVT | |||||
| Cirrhosis & recurrent ascites: 45% | Bilirubin >5 mg/dL | ||||
| sCr >3.0 mg/dL | |||||
| Advanced HCC | 2) Survival at 2 years: TIPS group, 58%; paracentesis group, 32% (P=0.11) | Partial response at 6 months: TIPS group, 5%; paracentesis group, 19% (P=N.S.) | |||
| Hepatic hydrothorax | |||||
| Technical failure of paracentesis | |||||
| Ginès et al. [44] (2002) | 119/70 | Cirrhosis & RA as defined by IAC criteria* | Age <18 or >75 years | 1) Severe HE at mean followup of 282–325 days: TIPS group, 60%; LVP group, 34% (P=0.03) | Median time to ascites recurrence: TIPS group, 171 days; paracentesis group, 20 days (P<0.0001) |
| HE ≥ grade 2 | |||||
| PVT | |||||
| Bilirubin >10 mg/dL | |||||
| sCr >3.0mg/dL | |||||
| Prothrombin index <40% | 2) Transplant free survival at 2 years: TIPS group, 26%; paracentesis group, 30% (P=0.51) | ||||
| Platelet <40×109/L | |||||
| HCC | |||||
| CHF | |||||
| Parenchymal renal disease | |||||
| Sanyal et al. [45] (2003) | 525/109 | Cirrhosis & RA as defined by IAC criteria* | HE ≥ grade 2 | 1) Severe HE: TIPS group, 38%; LVP group, 21% (P=0.058) | Recurrent ascites at 180 days: TIPS group, 6/57 (10.5%); paracentesis group, 26/52 (50%) (P<0.0001) |
| PVT | |||||
| sCr <1.5 mg/dL | Bilirubin >10 mg/dL | ||||
| INR >2.0 | |||||
| HCC | 2) Transplant free survival: TIPS group, 19.6 months; paracentesis group, 12.4 months (P=0.77) | ||||
| Bacterial infection | |||||
| Alcoholic hepatitis | |||||
| Cardiopulmonary failure | |||||
| Pulmonary hypertension | |||||
| Parenchymal renal disease | |||||
| Recent GI bleed | |||||
| Life limiting extra-hepatic disease | |||||
| Salerno et al. [49] (2007) | 137/66 | Cirrhosis & RA as defined by IAC criteria*: 68% | Age >72 years | 1) HE: TIPS group, 61%; LVP group, 39% (P=0.086) | Failure of treatment: TIPS group, 7/33 (21.2%); paracentesis group, 19/33 (57.6%) (P=0.0012) |
| HE ≥ grade 2 | |||||
| Cirrhosis & recidivant ascites: 32% | PVT | ||||
| Bilirubin >6 mg/dL | |||||
| sCr >3.0 mg/dL | 2) Transplant free survival at 2 years: TIPS group, 59%; paracentesis group, 29% (P=0.021) | ||||
| Child-Pugh score >11 | |||||
| Advanced HCC | |||||
| Bacterial infection | |||||
| Cardiopulmonary failure | |||||
| Recent GI bleed | |||||
| Narahara et al. [47] (2011) | 78/60 | Cirrhosis & RA as defined by IAC criteria* | Age >70 years | 1) Severe HE: TIPS group, 67%; LVP group, 17% (P<0.01) | Complete or partial response at 1 year: TIPS group, 20/30 (67%); paracentesis group, 8/30 (17%) (P<0.005) |
| Episodes of HE | |||||
| Bilirubin <3.0 mg/dL | PV cavernoma | ||||
| sCr <1.9 mg/dL | HCC or other Malignancy | 2) Overall survival at 2 years: TIPS group, 64%; paracentesis group, 35% (P<0.005) | |||
| Child-Pugh score <11 | Active infection | ||||
| Active severe | |||||
| Cardiac or pulmonary disease | |||||
| Organic kidney disease |
TIPS, transjugular intrahepatic portosystemic stent shunt; RA, refractory ascites; HE, hepatic encephalopathy; PVT, portal vein thrombosis; sCr, serum creatinine; HCC, hepatocellular carcinoma; LVP, large volume paracentesis; IAC, International Ascites Club; N.S., not significant; CHF, congestive heart failure; INR, international normalized ratio; GI, gastrointestinal; PV, portal vein.