Orloff 2015.

Methods	Randomised clinical trial
Participants	Country: USA Number randomised:70 participants representing a subset in an extended trial Analysis: intention‐to‐treat Age: mean age 50 years for both groups Initial endoscopic therapy before randomisations Duration of follow‐up: 10.5 years Inclusion criteria All cirrhotic participants with acute bleeding (less than four hours) from gastric varices confirmed by endoscopy Absence of bleeding from oesophageal varices or any other lesion that could account reasonably for the bleeding Diagnosis of cirrhosis by clinical, and laboratory data, liver biopsy to confirm cirrhosis Child‐Pugh class A, B, or C liver cirrhosis Suitability for intervention confirmed by ultrasound Requirement for two or more units of blood transfusion Exclusion criteria Absence of cirrhosis and bleeding from sources other than gastric varices Prominent cause of liver cirrhosis: alcohol‐related
Interventions	Emergency portocaval shunt (n = 34 ) versus emergency TIPS (n = 36 ) Either side‐to‐side or end‐to‐side portocaval shunt performed Only uncovered stents of variable sizes from 10 mm and above were used for TIPS Interventions performed within 24 hours of contact with study personnel Biopsy of liver performed during intervention
Outcomes	Mortality, variceal rebleeding, encephalopathy, health‐related quality of life, and economic costs
Notes	Treatment failure was defined as persistent or recurrent portal hypertension‐related bleeding: requiring transfusion of 4 or more units of packed red blood cells or whole blood during the first 7 days after intervention; requiring transfusion of 8 or more units after the first 7 days; or requiring transfusion of 8 or more units of blood during any 12‐month period; after the attending faculty endoscopist had previously declared the gastric varices obliterated or gone. Crossover rescue therapy not included in protocol but, "whenever possible, every effort was made to facilitate rescue treatment".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation achieved by a central computer‐generated random blocks
Allocation concealment (selection bias)	Low risk	Treatment allocation was concealed to investigators by "drawing an instruction card from a serially numbered, opaque, sealed envelope".
Blinding of participants and personnel (performance bias) All‐cause mortality; serious adverse events, variceal rebleed‐related mortality, variceal rebleeding, non‐serious adverse events.	Unclear risk	Participants and personnel were not blinded to the intervention received. Given the nature of the interventions, it was unrealistic to blind participants and study personnel to the intervention received
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	This information is not clear from the study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analysis was by intention‐to‐treat principle
Selective reporting (reporting bias)	Low risk	Trial protocol was published (NCT00820781). Reported protocol's predetermined outcomes
Other bias	Low risk	Study sponsored by institutional grant

DSRS ‐ distal splenorenal shunt; MELD ‐ model for end‐stage liver disease; TIPS ‐ transjugular intrahepatic portosystemic shunt