Table 1.
Characteristics of the included studies
| Study characteristics | Lebrec et al[10] | Rössle et al[9] | Ginès et al[8] | Sanyal et al[11] | Salerno et al[12] | Narahara et al[13] |
| Study design | Single-center, RCT | Multi-center, RCT | Multi-center, RCT | Multi-center, RCT | Multi-center, RCT | Single-center, RCT |
| Para | TP with albumin infusion (unclear dose) if creatinine clearance < 60 mL/min | LVP with albumin infusion (8 g/L of ascites removed) when clinically indicated | TP with albumin infusion (8 g/L of ascites removed) | TP with albumin infusion (6-8 g/L of ascites removed) | LVP with albumin infusion (8 g/L of ascites removed) | LVP with albumin infusion (6 g/L of ascites removed) |
| Study population | Cirrhotic patients with refractory ascites | Cirrhotic patients with refractory or recidivant ascites | Cirrhotic patients with refractory ascites | Cirrhotic patients with refractory ascites | Cirrhotic patients with refractory or recidivant ascites | Cirrhotic patients with refractory ascites |
| Definition of refractory ascites | Adequate diuretic and sodium restriction: body weight loss < 200 g/d in 5 d or > 2 tense ascites in 4 mo. | Definition reported in 1996 by International Ascites Club | Definition reported in 1996 by International Ascites Club | Definition reported in 1996 by International Ascites Club | Definition reported in 1996 by International Ascites Club | Definition reported in 1996 by International Ascites Club |
| Exclusion criteria | > 70 yr, HE, severe non-hepatic disease, pulmonary hypertension, PVT/HVT, HCC, active bacterial infection, severe alcoholic hepatitis, biliary obstruction, creatinine > 1.7 mg/dL | HE ≥ grade 2, bilirubin > 5 mg/dL, creatinine > 3 mg/dL, PVT, hepatic hydrothorax, advanced cancer, failure paracentesis | < 18 or > 75 yr, bilirubin > 10 mg/dL, INR > 2.5, PLT < 40000/mm3, creatinine > 3 mg/dL, HCC, complete PVT, cardiac or respiratory failure, organic renal failure, bacterial infection, and chronic HE | Bilirubin > 5 mg/dL, INR > 2, heart or renal failure, PVT, active bacterial infection, HE > grade 2, severe alcoholic hepatitis, HCC or incurable cancers, GI bleeding within 6 wk | > 72 yr, HE > grade 2, bilirubin > 6 mg/dL, Child-Pugh > 11, creatinine > 3 mg/dL, PVT, HCC, active bacterial infection, cardiac or pulmonary failure, GI bleeding within 15 d | > 70 yr, HE, HCC or other malignancy, PVT, active infection, severe cardiac or pulmonary disease, organic renal disease |
| Primary outcomes | Recurrence of ascites | Transplantation-free survival | Transplantation-free survival | Recurrence of ascites and transplantation-free survival | Transplantation-free survival | Overall survival |
| Secondary outcomes | Overall survival, HE, hemodynamic, liver and renal function | Recurrence of ascites, liver and renal function, HE | Recurrence of ascites, liver and renal function, HE, GI bleeding, HRS | Overall survival, HE, GI bleeding, liver and renal function, quality of life | Recurrence of ascites, HE, GI bleeding, liver and renal function, HRS | Recurrence of ascites, HE |
| Number of patients screened | NR | 155 | 119 | 525 | 137 | 78 |
| Randomized ratio | 1:01 | 1:01 | 1:01 | 1:01 | 1:01 | 1:01 |
| Number of patients randomized (total) | 25 | 60 | 70 | 109 | 66 | 60 |
| Number of participating centers | 1 | 2 | 4 | 6 | 3 | 1 |
| Mean follow-up time (TIPS/Para) | 7.5/12.4 | 45/44 | 9.5/10.8 | 41/38 | 21/15 | 27/13 |
RCT: Randomized controlled trial; NR: Not reported; TIPS: Transjugular intrahepatic portosystemic shunt; Para: Paracentesis; TP: Total paracentesis; LVP: Large-volume paracentesis; HE: Hepatic encephalopathy; PVT: Portal vein thrombosis; HVT: Hepatic vein thrombosis; HCC: Hepatocellular carcinoma; INR: International normalized ratio; PLT: Platelet count; GI: Gastrointestinal; HRS: Hepatorenal syndrome.