Table 3.
Randomised controlled trials of TIPS vs. LVP+A for recurrent/RA.
| Author | Sample size | Main inclusion criteria | Main exclusion criteria | Safety | Efficacy |
|---|---|---|---|---|---|
| Lebrec80 | 25 patients randomised 1:1 | Cirrhosis and RA defined by no response to maximal diuretic therapy for 5 days during hospitalisation or 2 or more episodes of tense ascites requiring hospitalisation over the prior 4 months | Age >70 years; HE ≥grade 2; PVT; Biliary obstruction; Serum creatinine >1.7 mg/dl; HCC; Active bacterial infection; Severe non-hepatic disease; Pulmonary hypertension | Increased incidence of PSE in the uncovered TIPS group | 2-year OS: 29% vs. 56%, favouring LVPs |
| Rossle81 | 155 consecutive patients evaluated; 60 patients randomised 1:1 |
Cirrhosis and RA as defined by ICA criteria (55%) or patients with recurrent ascites (45%) | HE ≥grade 2; PVT; Bilirubin >5 mg/dl; Serum creatinine >3 mg/dl; Advanced HCC; Hepatic hydrothorax; Technical failure of paracentesis | No difference in the incidence of PSE | 1- and 2-year TFS: 69% and 58% vs. 52% and 32% (n.s.), favouring uncovered TIPS; 61% vs. 18% had no ascites at 3 months, favouring uncovered TIPS |
| Gines82 | 119 consecutive patients; 70 patients randomised 1:1 |
Cirrhosis and RA as defined by ICA criteria | Age <18/>75 years; HE ≥grade 2; PVT; Bilirubin >10 mg/dl; Serum Creatinine >3 mg/dl; Prothrombin index <40%, PLT <40 G/L; CHF; HCC; Parenchymal kidney disease | No difference in the incidence of PSE but more episodes of severe PSE, favouring LVP | 1- and 2-year TFS: 41% and 26% vs. 35% and 30% in the uncovered TIPS vs. LVP groups, respectively (n.s.); Median time to recurrence of ascites of 171 days vs. 20 days, favouring uncovered TIPS |
| Sanyal83 | 525 consecutive patients; 109 patients randomised 1:1 |
Cirrhosis and RA as defined by ICA criteria; Serum creatinine <1.5 mg/dl | HE ≥grade 2, PVT; Bilirubin >5 mg/dl; INR >2; HCC; Bacterial infection; Alcoholic hepatitis; Cardiopulmonary failure; Pulmonary hypertension; Parenchymal kidney disease; Recent gastrointestinal bleeding; Life-limiting non-hepatic disease | Incidence of moderate to severe PSE: 38% vs. 21%, favouring LVP | TFS: 19.6 vs. 12.4 months, favouring uncovered TIPS; Lower rate of recurrent ascites in the uncovered TIPS group |
| Salerno84 | 137 consecutive patients; 66 patients randomised 1:1 |
Cirrhosis and RA as defined by ICA criteria (68%) or patients with ‘recidivant’ ascites (32%) | Age >72 years; HE ≥grade 2; Occlusive PVT; Child-Pugh >11 points; Bilirubin >6 mg/dl; Serum creatinine >3 mg/dl; Advanced HCC; Bacterial infection; Cardiopulmonary failure; Recent GI bleeding | Incidence of PSE: 61% vs. 39% (n.s.); Greater number of severe episodes per patient, favouring LVP |
1- and 2-year TFS: 77% and 59% vs. 52% and 29%, favouring uncovered TIPS; Lower rate of treatment failure in the uncovered TIPS group |
| Narahara85 | 78 consecutive patients; 60 patients randomised 1:1 |
Cirrhosis and RA as defined by ICA criteria; Child-Pugh <11 points; Bilirubin <3 mg/dl; Serum creatinine <1.9 mg/dl | Age >70 years; Episodes of HE; PV cavernoma; HCC or other malignancy; Active infection; Active severe cardiac or pulmonary disease; Organic kidney disease | Increased incidence of PSE and severe PSE in the uncovered TIPS group | 1- and 2-year OS: 80% and 64% vs. 49% and 35%, favouring uncovered TIPS; Improved control of ascites and less treatment failure, favouring uncovered TIPS |
| Bureau86 | 137 consecutive patients; 62 patients randomised 1:1 | Cirrhosis; Age >18/<70 years; Recurrent tense ascites requiring at least 2 LVP within the prior 3 weeks | >6 LVPs within the previous 3 months; Expected to receive transplant within the next 6 months or on waiting list; Recurrent overt HE; Occlusive PVT, Child-Pugh >12 points; Bilirubin >5.8 mg/dl; Serum Creatinine >2.8 mg/dl; HCC; CHF; pulmonary hypertension | No difference in rates of overt PSE | 1-year TFS: 93% vs. 52%, favouring PFTE-covered TIPS; Free of treatment failure: 89% vs. 29%, favouring PFTE-covered TIPS |
CHF, chronic heart failure; HCC, hepatocellular carcinoma; HE, hepatic encephalopathy; IAC, International Ascites Club; INR, international normalised ratio; LVP+A, large-volume paracentesis with albumin; OS, overall survival; PFTE, polytetrafluoroethylene; PLT, platelet count; PSE, portosystemic encephalopathy; PVT, portal vein thrombosis; RA, refractory ascites; RCT, randomised controlled trials; TFS, transplant-free survival; TIPS, transjugular intrahepatic portosystemic shunt.