Transjugular intrahepatic portosystemic shunt in cirrhosis: An exhaustive critical update

Table 2 Summary of the randomised controlled trials on transjugular intrahepatic portosystemic shunt in patients with ascites

Ref.	No. of pts (LVP/TIPS)	Definition of ascites for inclusion	Exclusion criteria	Primary and secondary outcomes and mean follow-up time (LVP/TIPS) in months	Improvement in ascites (%; LVP/TIPS)	HE (%; LVP/TIPS)	Survival (%; LVP/TIPS)
Lebrec et al[49]	12/13	Despite adequate diuretics and sodium restriction: (1) Weight loss < 200 g/d in 5 d or (2) > 2 episodes of tense ascites in 4 mth	Age > 70 yr, severe extra-hepatic diseases, HCC, pulmonary hypertension, HE, bacterial infection, severe alcoholic hepatitis, portal or hepatic vein obstruction or thrombosis, obstruction of biliary tract, obstruction of hepatic artery, serum creatinine >1.7 mg/dL	Primary: Recurrence of ascites; secondary: Overall survival, HE, hemodynamic, liver; and renal function; Follow-up: 12.4/7.5	0/38	6/15	60/29
Rossle et al[80]	31/29	Definition reported in 1996 by IAC (45% patients had recidivant ascites)	Overt HE, serum bilirubin > 5 mg/dL, serum creatinine > 3 mg/dL, PVT, hepatic hydrothorax, advanced cancer, failure of LVP (ascites persisting after LVP or need for LVP > once per week)	Primary: TFS; secondary: Recurrence of ascites, liver and renal function, HE; Follow-up: 44/45	43/84	13/23	32/58
Gines et al[81]	35/35	Definition reported in 1996 by IAC	Age > 18 or > 75 yr; serum bilirubin > 10 mg/dL; prothrombin time < 40% (INR 2.5); platelet count < than 40000/mm3; serum creatinine > 3 mg/dL, HCC, complete portal vein thrombosis; cardiac or respiratory failure; organic renal failure; bacterial infection; chronic HE	Primary: TFS; secondary: Recurrence of ascites, liver and renal function, HE, GI, bleeding, HRS; Follow-up: 10.8/9.5	17/51	34/60	30/26
Sanyal et al[82]	57/52	Definition reported in 1996 by IAC	Causes of ascites other than cirrhosis, advanced liver failure (serum bilirubin bilirubin > 5 mg/dL, PT INR > 2), incurable cancers or nonhepatic diseases that were likely to limit life expectancy to 1 yr, congestive heart failure, acute renal failure, parenchymal renal disease, PVT; bacterial infections, overt HE, florid alcoholic hepatitis, HCC, GI hemorrhage within 6 wk of randomisation	Primary: Recurrence of ascites and TFS; secondary: Overall survival, HE, GI bleeding, liver and renal function, quality of life; Follow-up: 38/41	16/58	21/38	33/35
Salerno et al[83]	33/33	Definition reported in 1996 by IAC (32% patients had recidivant ascites)	Age > 72 yr, recurrent overt HE, serum bilirubin > 6 mg/dL, serum creatinine > 3 mg/dL, CTP score> 11, complete PVT; HCC; GI bleeding within 15 d of randomisation, serious cardiac or pulmonary dysfunctions, bacterial infection, SAAG gradient < 11 g/L	Primary: TFS; secondary: Recurrence of ascites, HE, GI bleeding, liver and renal function, HRS; Follow-up: 15/21	42/79	39/61	29/59
Narahara et al[88]	30/30	Definition reported in 1996 by IAC	Age > 70 yr, chronic HE, HCC and other malignancies, complete portal vein thrombosis with cavernomatous transformation, bacterial infection, severe cardiac or pulmonary disease, organic renal disease	Primary: Overall survival; secondary: Recurrence of ascites, HE; Follow-up: 13/27	30/87	17/67	30/43
Bureau et al[92]	33/29	At least 2 LVPs within a minimum interval of 3 wk	Age < 18 and > 70 yrs, patients who had required > 6 LVPs within the previous 3 mo; patients on transplant waiting list, congestive heart failure, history or presence of pulmonary hypertension, complete PVT, recurrent overt HE, HCC, severe liver failure (prothrombin index < 35%, total bilirubin > 100 mmol/L or CTP score > 12), serum creatinine > 250 mmol/L, uncontrolled sepsis	Primary: 1-yr liver TFS; secondary: Ascites recurrence and treatment failure, overt HE, PHT-related complications, other complications of cirrhosis, and the number of days in hospital during a 1-yr period after inclusion; Follow-up: 10.4 /11.5	At 1-yr follow-up, total number of paracentesis in the TIPS and LVP group were 32 and 320, respectively	35/35	52/93

HCC: Hepatocellular carcinoma; HE: Hepatic encephalopathy; IAC: International ascites club; PVT: Portal vein thrombus; LVP: Large volume paracentesis; TFS: Transplant free survival; INR: International normalised ratio; HCC: Hepatocellular carcinoma; GI: Gastrointestinal; HRS: Hepatorenal syndrome; PVT: Portal vein thrombus; CTP: Child-Turcotte-Pugh; SAAG: Serum ascites albumin gradient; PHT: Portal hypertension; TIPS: Transjugular intrahepatic portosystemic shunt.