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Meta-Analysis
. 2018 Oct 31;10(10):CD001023.
doi: 10.1002/14651858.CD001023.pub3.

Surgical portosystemic shunts versus transjugular intrahepatic portosystemic shunt for variceal haemorrhage in people with cirrhosis

Martin Brand  1 , Leanne Prodehl, Chikwendu J Ede
Affiliations
Meta-Analysis

Surgical portosystemic shunts versus transjugular intrahepatic portosystemic shunt for variceal haemorrhage in people with cirrhosis

Martin Brand et al. Cochrane Database Syst Rev. .

Abstract

Background: Variceal haemorrhage that is refractory or recurs after pharmacologic and endoscopic therapy requires a portal decompression shunt (either surgical shunts or radiologic shunt, transjugular intrahepatic portosystemic shunt (TIPS)). TIPS has become the shunt of choice; however, is it the preferred option? This review assesses evidence for the comparisons of surgical portosystemic shunts versus TIPS for variceal haemorrhage in people with cirrhotic portal hypertension.

Objectives: To assess the benefits and harms of surgical portosystemic shunts versus transjugular intrahepatic portosystemic shunt (TIPS) for treatment of refractory or recurrent variceal haemorrhage in people with cirrhotic portal hypertension.

Search methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index - Science. We also searched on-line trial registries, reference lists of relevant articles, and proceedings of relevant associations for trials that met the inclusion criteria for this review (date of search 8 March 2018).

Selection criteria: Randomised clinical trials comparing surgical portosystemic shunts versus TIPS for the treatment of refractory or recurrent variceal haemorrhage in people with cirrhotic portal hypertension.

Data collection and analysis: Two review authors independently assessed trials and extracted data using methodological standards expected by Cochrane. We assessed risk of bias according to domains and risk of random errors with Trial Sequential Analysis (TSA). We assessed the certainty of the evidence using the GRADE approach.

Main results: We found four randomised clinical trials including 496 adult participants diagnosed with variceal haemorrhage due to cirrhotic portal hypertension. The overall risk of bias in all the trials was judged at high risk. All the trials were conducted in the United States of America (USA). Two of the trials randomised participants to selective surgical shunts versus TIPS. The other two trials randomised participants to non-selective surgical shunts versus TIPS. The diagnosis of liver cirrhosis was by clinical and laboratory findings. We are uncertain whether there is a difference in all-cause mortality at 30 days between surgical portosystemic shunts compared with TIPS (risk ratio (RR) 0.94, 95% confidence interval (CI) 0.44 to 1.99; participants = 496; studies = 4). We are uncertain whether there is a difference in encephalopathy between surgical shunts compared with TIPS (RR 0.56, 95% CI 0.27 to 1.16; participants = 496; studies = 4). We found evidence suggesting an increase in the occurrence of the following harms in the TIPS group compared with surgical shunts: all-cause mortality at five years (RR 0.61, 95% CI 0.42 to 0.90; participants = 496; studies = 4); variceal rebleeding (RR 0.18, 95% CI 0.07 to 0.49; participants = 496; studies = 4); reinterventions (RR 0.13, 95% CI 0.06 to 0.28; participants = 496; studies = 4); and shunt occlusion (RR 0.14, 95% CI 0.04 to 0.51; participants = 496; studies = 4). We could not perform an analysis of health-related quality of life but available evidence appear to suggest improved health-related quality of life in people who received surgical shunt compared with TIPS. We downgraded the certainty of the evidence for all-cause mortality at 30 days and five years, irreversible shunt occlusion, and encephalopathy to very low because of high risk of bias (due to lack of blinding); inconsistency (due to heterogeneity); imprecision (due to small sample sizes of the individual trials and few events); and publication bias (few trials reporting outcomes). We downgraded the certainty of the evidence for variceal rebleeding and reintervention to very low because of high risk of bias (due to lack of blinding); imprecision (due to small sample sizes of the individual trials and few events); and publication bias (few trials reporting outcomes). The small sample sizes and few events did not allow us to produce meaningful trial sequential monitoring boundaries, suggesting plausible random errors in our estimates.

Authors' conclusions: We found evidence suggesting that surgical portosystemic shunts may have benefit over TIPS for treatment of refractory or recurrent variceal haemorrhage in people with cirrhotic portal hypertension. Given the very low-certainty of the available evidence and risks of random errors in our analyses, we have very little confidence in our review findings.

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Conflict of interest statement

MB has on conflict of interest to declare LP has no conflict of interest to declare CJE has no conflict of interest to declare

Figures

1
1
Study flow diagram. A total of 2512 records identified through electronic database search. After removing 904 duplicates, a total of 1608 references were screened for titles and abstracts, eight articles were selected for full‐text review. Of these, three articles were retrospective studies and one article was a prospective non‐randomised study. Four studies were selected for final meta‐analysis.
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 all‐cause mortality at 5 years calculated based on control event rate of 55%; a RRR of 20%; a type I error of 2.5%, a type II error of 10%; and diversity of 70%. The DARIS of 3400 was not achieved and Z‐curve did not cross the alpha spending boundary, (RR 0.61, alpha spending boundary adjusted CI 0.13 to 2.86).
5
5
Trial Sequential Analysis for variceal rebleeding episodes at 30 days is calculated based on control event rate of 12%; a RRR of 20%; a type I error of 2.5%, a type II error of 10%; and diversity of 0%. The DARIS of 8304 was not achieved and Z‐curve did not cross the alpha‐spending boundary (RR 0.18, alpha‐spending boundary‐adjusted CI 0.00 to 10.31).
6
6
Trial Sequential Analysis for number of participants with reinterventions at 5 years is calculated based on control event rate of 52%; a RRR of 20%; a type I error of 2.5%, a type II error of 10%; and diversity of 56%. The DARIS of 2594 was not achieved and Z‐curve did not cross the alpha‐spending boundary (RR 0.13, alpha‐spending boundary‐adjusted CI 0.01 to 2.80).
1.1
1.1. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 1 All‐cause mortality at 30 days.
1.2
1.2. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 2 All‐cause mortality at 5 years.
1.3
1.3. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 3 Variceal rebleed‐related mortality at 30 days.
1.4
1.4. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 4 Variceal rebleeding episodes at 30 days.
1.5
1.5. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 5 Number of participants transplanted at 10 years follow‐up.
1.6
1.6. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 6 Number of participants with reinterventions at 5 years.
1.7
1.7. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 7 Irreversible shunt occlusion at 5 years.
1.8
1.8. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 8 Encephalopathy (persistent or new‐onset) at 5 years.
1.9
1.9. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 9 Ascites (persistent and new‐onset) at 5 years.
1.10
1.10. Analysis
Comparison 1 Surgical shunts versus transjugular intrahepatic portosystemic shunt (TIPS), Outcome 10 Survival at 5 years by Child class.
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