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. 2024 Jan 18;1(1):CD011039.
doi: 10.1002/14651858.CD011039.pub2.

Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome

Alejandro G Gonzalez-Garay  1 , Aurora E Serralde-Zúñiga  2 , Liliana Velasco Hidalgo  3 , Nayelli Cointa Flores García  4 , Ma Isabel Aguirre-Salgado  5
Affiliations

Transjugular intrahepatic portosystemic shunts for adults with hepatorenal syndrome

Alejandro G Gonzalez-Garay et al. Cochrane Database Syst Rev. .

Abstract

Background: Hepatorenal syndrome is a condition that occurs in people with chronic liver disease (such as alcoholic hepatitis, advanced cirrhosis, or fulminant liver failure) and portal hypertension. The prognosis is dismal, often with a survival of weeks to months. Hepatorenal syndrome is characterised by the development of intense splanchnic vasodilation favouring ascites and hypotension leading to renal vasoconstriction and acute renal failure. Therefore, treatment attempts focus on improving arterial pressure through the use of vasopressors, paracentesis, and increasing renal perfusion pressure. Several authors have reported that the placement of transjugular intrahepatic portosystemic shunts (TIPS) may be a therapeutic option because it decreases portal pressure and improves arterial and renal pressures. However, the evidence is not clearly documented and TIPS may cause adverse events. Accordingly, it is necessary to evaluate the evidence of the benefits and harms of TIPS to assess its value in people with hepatorenal syndrome.

Objectives: To evaluate the benefits and harms of transjugular intrahepatic portosystemic shunts (TIPS) in adults with hepatorenal syndrome compared with sham, no intervention, conventional treatment, or other treatments.

Search methods: We used standard, extensive Cochrane search methods. The latest search date was 2 June 2023.

Selection criteria: We included only randomised clinical trials with a parallel-group design, which compared the TIPS placement with sham, no intervention, conventional therapy, or other therapies, in adults aged 18 years or older, regardless of sex or ethnicity, diagnosed with chronic liver disease and hepatorenal syndrome. We excluded trials of adults with kidney failure due to causes not related to hepatorenal syndrome, and we also excluded data from quasi-randomised, cross-over, and observational study designs as we did not design a separate search for such studies.

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were 1. all-cause mortality, 2. morbidity due to any cause, and 3. serious adverse events. Our secondary outcomes were 1. health-related quality of life, 2. non-serious adverse events, 3. participants who did not receive a liver transplant, 4. participants without improvement in kidney function, and 5. length of hospitalisation. We performed fixed-effect and random-effects meta-analyses using risk ratio (RR) or Peto odds ratio (Peto OR), with 95% confidence intervals (CI) for the dichotomous outcomes and mean difference (MD) or standardised mean difference (SMD) for the continuous outcomes. We used GRADE to assess certainty of evidence.

Main results: We included two randomised clinical trials comparing TIPS placement (64 participants) versus conventional treatment (paracentesis plus albumin 8 g/L of removed ascites) (66 participants). The co-interventions used in the trials were dietary treatment (sodium less than 60 mmoL/day), spironolactone (300 mg/day to 400 mg/day), and furosemide (120 mg/day). Follow-up was up to 24 months. Both were multicentre trials from Spain and the USA, and Germany, conducted between 1993 and 2002. Most participants were men (aged 18 to 75 years). We are uncertain about the effect of TIPS placement compared with conventional treatment, during the first 24 months of follow-up, on all-cause mortality (RR 0.88, 95% CI 0.55 to 1.38; 2 trials, 130 participants; I2 = 58%; very low-certainty evidence) and on the development of any serious adverse event (RR 1.60, 95% CI 0.10 to 24.59; 2 trials, 130 participants; I2 = 78%; very low-certainty evidence). The use of TIPS may or may not result in a decrease in overall morbidity such as bacterial peritonitis, encephalopathy, or refractory ascites, during the first 24 months of follow-up, compared with the conventional treatment (RR 0.95, 95% CI 0.77 to 1.18; 2 trials, 130 participants; I2 = 0%; low-certainty evidence). We are uncertain about the effect of TIPS placement versus conventional treatment on the number of people who did not receive a liver transplant (RR 1.03, 95% CI 0.93 to 1.14; 2 trials, 130 participants; I2 = 0%; very low-certainty evidence) or on the length of hospitalisation (MD -20.0 days, 95% CI -39.92 to -0.08; 1 trial, 60 participants; very low-certainty evidence). Kidney function may improve in participants with TIPS placement (RR 0.53, 95% CI 0.27 to 1.02; 1 trial, 70 participants; low-certainty evidence). No trials reported health-related quality of life, non-serious adverse events, or number of participants with improvement in liver function associated with the TIPS placement. Funding No trials reported sources of commercial funding or conflicts of interest between researchers. Ongoing studies We found one ongoing trial comparing TIPS with conventional therapy (terlipressin plus albumin) and listed one study as awaiting classification as no full-text article could be found.

Authors' conclusions: TIPS placement was compared with conventional treatment, with a follow-up of 24 months, in adults with hepatorenal syndrome type 2. Based on two trials with insufficient sample size and trial limitations, we assessed the overall certainty of evidence as low or very low. We are unsure if TIPS may decrease all-cause mortality, serious adverse events, the number of people who did not receive a liver transplant, and the days of hospitalisation because of the very low-certainty evidence. We are unsure if TIPS, compared with conventional treatment, has better effects on overall morbidity (bacterial peritonitis, encephalopathy, or refractory ascites). TIPS may improve kidney function, but the certainty of evidence is low. The trials included no data on health-related quality of life, non-serious adverse events, and liver function associated with the TIPS placement. We identified one ongoing trial and one study awaiting classification which may contribute to the review when information becomes available.

Trial registration: ClinicalTrials.gov NCT00222014 NCT04315571 NCT05346393.

PubMed Disclaimer

Conflict of interest statement

AG: none.

AS: none.

LV: none.

NF: none.

IA: none.

Figures

1
1
PRISMA flow diagram (Page 2021a; Page 2021b). Date of search 2 June 2023.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Trial Sequential Analysis for transjugular intrahepatic portosystemic shunts versus conventional therapy on all‐cause mortality in people with hepatorenal syndrome. The Trial Sequential Analysis is constructed with the x‐axis denoting the accrued number of participants and the required number of participants. The y‐axis denotes the cumulative Z‐values in the Trial Sequential Analysis. The blue line (Z‐curve) represents the cumulative Z‐value. Trial Sequential Analysis showed that the diversity‐adjusted required information size (DARIS) was 1453 participants, calculated based on the proportion of events of 62% in the control group, a relative risk reduction (RRR) of 20%, an alpha (type I error) of 2.5%, a beta (type II error) of 20%, and a diversity of 58%. The cumulative Z‐curve did not cross the conventional boundaries after the inclusion of two trials (130 participants), suggesting that no conclusive evidence can be reached based on the current trials; hence, more trials are needed. The Trial Sequential Analysis‐adjusted confidence interval was 0.14 to 5.67. The horizontal green dotted lines show the threshold for significance in conventional naïve meta‐analysis, at 1.96 of a Z‐value, corresponding to a P value of 0.05. The red lines at the top and bottom right corners show the trial sequential boundaries for benefit or harm, respectively, representing the threshold for statistical significance in the Trial Sequential Analysis.
5
5
Trial Sequential Analysis for transjugular intrahepatic portosystemic shunts versus conventional therapy on morbidity due to any cause in people with hepatorenal syndrome. The graph is constructed with the x‐axis denoting the accumulated number of participants and the required number of participants. The y‐axis denotes the cumulative Z‐values in the Trial Sequential Analysis. The blue line (Z‐curve) shows the cumulative Z‐value. The Trial Sequential Analysis indicates that the diversity‐adjusted required information size (DARIS) is 513 participants, determined by the proportion of events of 66.7% in the control group; a relative risk reduction (RRR) of 20%; an alpha (type I error) of 2.5%; a beta (type II error) of 20%; and a diversity of 0%. The cumulative Z‐curve does not cross the conventional boundaries after the inclusion of two trials (130 participants) or the trial sequential monitoring boundary of benefit or harm, suggesting that the current trials are insufficient to make any conclusive decision; therefore, more trials are required. The Trial Sequential Analysis‐adjusted confidence interval is 0.56 to 1.61. The horizontal green dotted lines show the significance threshold in conventional naive meta‐analysis at 1.96 of a Z‐value, corresponding to a P value of 0.05. The red lines at the top and bottom right corners show the trial sequential boundaries for benefit or harm, respectively, representing the threshold for statistical significance in the Trial Sequential Analysis.
6
6
Trial Sequential Analysis for transjugular intrahepatic portosystemic shunts versus conventional therapy on serious adverse events in people with hepatorenal syndrome. The Trial Sequential Analysis was constructed with the x‐axis denoting the accumulated number of participants and the required number of participants. The y‐axis denotes the cumulative Z‐values in the Trial Sequential Analysis. The blue line (Z‐curve) shows the cumulative Z‐value. Trial Sequential Analysis showed that the diversity‐adjusted required information size (DARIS) was 39,709 participants, calculated based on the proportion of events of 9% in the control group, a relative risk reduction (RRR) of 20%, an alpha (type I error) of 2.5%, a beta (type II error) of 20%, and a diversity of 78%. The cumulative Z‐curve did not cross conventional boundaries after the inclusion of two trials (130 participants). The alpha spending function was ignored because we accrued less than 5% of the required participants; hence, no conclusive evidence was found. The horizontal green dotted lines show the threshold for significance in conventional naïve meta‐analysis, at 1.96 of the Z‐value, corresponding to the P value of 0.05.
1.1
1.1. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 2: Morbidity due to any cause
1.3
1.3. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 3: Morbidity (by type)
1.4
1.4. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 4: Serious adverse events
1.5
1.5. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 5: Serious adverse events (by type)
1.6
1.6. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 6: Participants who did not receive a liver transplant
1.7
1.7. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 7: Participants without improvement in kidney function (first 24 months of follow‐up)
1.8
1.8. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 8: Improvement in kidney function (parameters)
1.9
1.9. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 9: Improvement in liver function (parameters)
1.10
1.10. Analysis
Comparison 1: Transjugular intrahepatic portosystemic shunts (TIPS) versus conventional treatment, Outcome 10: Length of hospitalisation measured in days (first 12 months of follow‐up)
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Update of

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