TIPS improves liver transplantation-free survival in cirrhotic patients with refractory ascites: An updated meta-analysis

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.