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Meta-Analysis
. 2020 Oct 22;10(10):CD000553.
doi: 10.1002/14651858.CD000553.pub3.

Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis

Rosa G Simonetti  1 , Giovanni Perricone  2 , Helen L Robbins  3   4 , Narendra R Battula  5 , Martin O Weickert  6 , Robert Sutton  7 , Saboor Khan  8
Affiliations
Meta-Analysis

Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis

Rosa G Simonetti et al. Cochrane Database Syst Rev. .

Abstract

Background: People with liver cirrhosis who have had one episode of variceal bleeding are at risk for repeated episodes of bleeding. Endoscopic intervention and portosystemic shunts are used to prevent further bleeding, but there is no consensus as to which approach is preferable.

Objectives: To compare the benefits and harms of shunts (surgical shunts (total shunt (TS), distal splenorenal shunt (DSRS), or transjugular intrahepatic portosystemic shunt (TIPS)) versus endoscopic intervention (endoscopic sclerotherapy or banding, or both) with or without medical treatment (non-selective beta blockers or nitrates, or both) for prevention of variceal rebleeding in people with liver cirrhosis.

Search methods: We searched the CHBG Controlled Trials Register; CENTRAL, in the Cochrane Library; MEDLINE Ovid; Embase Ovid; LILACS (Bireme); Science Citation Index - Expanded (Web of Science); and Conference Proceedings Citation Index - Science (Web of Science); as well as conference proceedings and the references of trials identified until 22 June 2020. We contacted study investigators and industry researchers.

Selection criteria: Randomised clinical trials comparing shunts versus endoscopic interventions with or without medical treatment in people with cirrhosis who had recovered from a variceal haemorrhage.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. When possible, we collected data to allow intention-to-treat analysis. For each outcome, we estimated a meta-analysed estimate of treatment effect across trials (risk ratio for binary outcomes). We used random-effects model meta-analysis as our main analysis and as a means of presenting results. We reported differences in means for continuous outcomes without a meta-analytic estimate due to high variability in their assessment among all trials. We assessed the certainty of evidence using GRADE.

Main results: We identified 27 randomised trials with 1828 participants. Three trials assessed TSs, five assessed DSRSs, and 19 trials assessed TIPSs. The endoscopic intervention was sclerotherapy in 16 trials, band ligation in eight trials, and a combination of band ligation and either sclerotherapy or glue injection in three trials. In eight trials, endoscopy was combined with beta blockers (in one trial plus isosorbide mononitrate). We judged all trials to be at high risk of bias. We assessed the certainty of evidence for all the outcome review results as very low (i.e. the true effects of the results are likely to be substantially different from the results of estimated effects). The very low evidence grading is due to the overall high risk of bias for all trials, and to imprecision and publication bias for some outcomes. Therefore, we are very uncertain whether portosystemic shunts versus endoscopy interventions with or without medical treatment have effects on all-cause mortality (RR 0.99, 95% CI 0.86 to 1.13; 1828 participants; 27 trials), on rebleeding (RR 0.40, 95% CI 0.33 to 0.50; 1769 participants; 26 trials), on mortality due to rebleeding (RR 0.51, 95% CI 0.34 to 0.76; 1779 participants; 26 trials), and on occurrence of hepatic encephalopathy, both acute (RR 1.60, 95% CI 1.33 to 1.92; 1649 participants; 24 trials) and chronic (RR 2.51, 95% CI 1.38 to 4.55; 956 participants; 13 trials). No data were available regarding health-related quality of life. Analysing each modality of portosystemic shunts individually (i.e. TS, DSRS, and TIPS) versus endoscopic interventions with or without medical treatment, we are very uncertain if each type of shunt has effect on all-cause mortality: TS, RR 0.46, 95% CI 0.19 to 1.13; 164 participants; 3 trials; DSRS, RR 0.93, 95% CI 0.65 to 1.33; 352 participants; 4 trials; and TIPS, RR 1.10, 95% CI 0.92 to 1.31; 1312 participants; 19 trial; on rebleeding: TS, RR 0.28, 95% CI 0.14 to 0.56; 127 participants; 2 trials; DSRS, RR 0.26, 95% CI 0.11 to 0.65; 330 participants; 5 trials; and TIPS, RR 0.44, 95% CI 0.36 to 0.55; 1312 participants; 19 trials; on mortality due to rebleeding: TS, RR 0.25, 95% CI 0.06 to 0.96; 164 participants; 3 trials; DSRS, RR 0.31, 95% CI 0.13 to 0.74; 352 participants; 5 trials; and TIPS, RR 0.65, 95% CI 0.40 to 1.04; 1263 participants; 18 trials; on acute hepatic encephalopathy: TS, RR 1.66, 95% CI 0.70 to 3.92; 115 participants; 2 trials; DSRS, RR 1.70, 95% CI 0.94 to 3.08; 287 participants; 4 trials, TIPS, RR 1.61, 95% CI 1.29 to 1.99; 1247 participants; 18 trials; and chronic hepatic encephalopathy: TS, Fisher's exact test P = 0.11; 69 participants; 1 trial; DSRS, RR 4.87, 95% CI 1.46 to 16.23; 170 participants; 2 trials; and TIPS, RR 1.88, 95% CI 0.93 to 3.80; 717 participants; 10 trials. The proportion of participants with shunt occlusion or dysfunction was overall 37% (95% CI 33% to 40%). It was 3% (95% CI 0.8% to 10%) following TS, 7% (95% CI 3% to 13%) following DSRS, and 47.1% (95% CI 43% to 51%) following TIPS. Shunt dysfunction in trials utilising polytetrafluoroethylene-covered stents was 17% (95% CI 11% to 24%). Length of inpatient hospital stay and cost were not comparable across trials. Funding was unclear in 16 trials; 11 trials were funded by government, local hospitals, or universities.

Authors' conclusions: Evidence on whether portosystemic shunts versus endoscopy interventions with or without medical treatment in people with cirrhosis and previous hypertensive portal bleeding have little or no effect on all-cause mortality is very uncertain. Evidence on whether portosystemic shunts may reduce bleeding and mortality due to bleeding while increasing hepatic encephalopathy is also very uncertain. We need properly conducted trials to assess effects of these interventions not only on assessed outcomes, but also on quality of life, costs, and length of hospital stay.

Trial registration: ClinicalTrials.gov NCT00570973 NCT01326949 NCT00690027 NCT02477384 NCT03094234.

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Conflict of interest statement

RGS: nothing to declare. GP: nothing to declare. HLR: nothing to declare. NRB: nothing to declare. MOW: nothing to declare. RS: nothing to declare. SK: nothing to declare.

Figures

1
1
Study flow diagram. Searches performed up to June 2020
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Funnel plot of comparison: 1 Portosystemic shunt versus endoscopic intervention with or without medical treatment, outcome: 1.1 All‐cause mortality
5
5
Funnel plot of comparison: 1 Portosystemic shunt versus endoscopic intervention with or without medical treatment, outcome: 1.2 Rebleeding
6
6
Funnel plot of comparison: 1 Portosystemic shunt versus endoscopic intervention with or without medical treatment, outcome: 1.3 Mortality due to rebleeding
7
7
Funnel plot of comparison: 1 Portosystemic shunt versus endoscopic intervention with or without medical treatment, outcome: 1.4 Acute hepatic encephalopathy
8
8
Funnel plot of comparison: 1 Portosystemic shunt versus endoscopic intervention with or without medical treatment, outcome: 1.5 Chronic hepatic encephalopathy
1.1
1.1. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 2: Rebleeding
1.3
1.3. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 3: Mortality due to rebleeding
1.4
1.4. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 4: Acute hepatic encephalopathy
1.5
1.5. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 5: Chronic hepatic encephalopathy
1.6
1.6. Analysis
Comparison 1: Portosystemic shunts versus endoscopic intervention with or without medical treatment, Outcome 6: Rebleeding from all causes
2.1
2.1. Analysis
Comparison 2: Portosystemic shunts versus endoscopic intervention with or without medical treatment regarding funding, Outcome 1: All‐cause mortality
2.2
2.2. Analysis
Comparison 2: Portosystemic shunts versus endoscopic intervention with or without medical treatment regarding funding, Outcome 2: Rebleeding
2.3
2.3. Analysis
Comparison 2: Portosystemic shunts versus endoscopic intervention with or without medical treatment regarding funding, Outcome 3: Mortality due to rebleeding
2.4
2.4. Analysis
Comparison 2: Portosystemic shunts versus endoscopic intervention with or without medical treatment regarding funding, Outcome 4: Acute hepatic encephalopathy
2.5
2.5. Analysis
Comparison 2: Portosystemic shunts versus endoscopic intervention with or without medical treatment regarding funding, Outcome 5: Chronic hepatic encephalopathy
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References

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References to studies awaiting assessment

Lv 2019 {published data only}
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References to ongoing studies

NCT02477384 {published data only}
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NCT03094234 {published data only}
    1. NCT03094234. 8mm-TIPS versus endoscopic variceal ligation (EVL) plus propranolol for prevention of variceal rebleeding in patients with child A cirrhosis. clinicaltrials.gov/ct2/show/study/NCT03094234 (first received 23 March 2017).

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References to other published versions of this review

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