Background
Varices are enlarged thin walled vessels found in the walls of the oesophagus and stomach of people with high blood pressure in the portal circulation (blood vessels supplying the liver with blood from the bowels). Bleeding from varices are not uncommon and maybe life-threatening. The first-line treatment of this bleeding is with medications and endoscopy (use of a long tube fitted with camera to locate and occlude the varices with elastic bands). Most people will respond to the first-line treatment, but a few will continue to bleed or have repeat bleeding. This later group will require further treatments in the form of shunts (tubes that divert blood from portal circulation direct to the heart). There are two types of shunts; one that is created through a surgical operation and called surgical shunt, the other is created with the help of an ultrasound machine and called radiologic shunt. Both types of shunts have their benefits and harms. This review was done to determine whether surgical shunts are better than radiologic shunt in treating persistent and repeat bleeding due to varices in people with cirrhosis (chronic disease of the liver in which normal liver cells are replaced by hard scar).
Study characteristics
We found four randomised clinical trials in which 496 adult participants were allowed to receive either a surgical shunt or a radiologic shunt. There were problems with the design of the trials as they had small number of participants and used different shunt types. We judged all four trials at high risk of bias (trials may have overestimated the true effect of shunts treatment).
Key results
We found no difference in the number of participants who died within 30 days of treatment, and the number that developed encephalopathy (disease of the brain due to toxins bypassing the liver to reach the brain), when surgical shunts were compared with radiologic shunt. We found evidence suggesting more harms with radiologic shunt when we considered the number of participants that died five years after treatment; or had repeat bleeding; or required repeated treatment; or had shunt blockage; that appeared to be more in the radiologic shunt group.
Conclusions
Surgical shunts appear to be better than radiologic shunt for treating persistent and repeated bleeding due to varices in people with liver cirrhosis. Given the very low certainty of the evidence due to problems with design of the trials and inadequate number of participants, we are unsure if our conclusion is correct. Future trials with better design and adequate number of participants will likely produce results that are reliable.
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.
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.
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.
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).
Randomised clinical trials comparing surgical portosystemic shunts versus TIPS for the treatment of refractory or recurrent variceal haemorrhage in people with cirrhotic portal hypertension.
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.
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.