Orloff 2012.

Methods	Randomised clinical trial
Participants	Country: USA Number randomised: 154 participants Analysis: intention‐to‐treat Age: mean age 49 years for both groups Initial combined endoscopic sclerotherapy and pharmacotherapy before randomisations Duration of follow‐up: 15 years Inclusion criteria All cirrhotic participants with acute (< 48 hours) bleeding from oesophageal varices or portal hypertensive gastropathy confirmed by upper endoscopy Diagnosis of cirrhosis by clinical, and laboratory data 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 oesophageal varices Prominent cause of liver cirrhosis: alcohol‐related
Interventions	Emergency portocaval shunt (n = 76) versus emergency TIPS (n = 78) Either side‐to‐side or end‐to‐side portocaval shunt performed Only uncovered stents of variable sizes from 12 mm and above were used for TIPS Interventions performed within 24 hours of contact with study personnel Biopsy of liver performed during intervention
Outcomes	Survival, variceal rebleeding, encephalopathy, health‐related quality of life, and economic costs
Notes	Treatment failure was defined as: variceal bleeding requiring six or more units of blood over and above normal transfusion requirements in first 8 days after study entry; variceal rebleeding that required eight units of blood transfusion during any 12‐month period; or variceal rebleeding after participant deemed cured following endoscopy. Rescue therapy was defined as use of alternative intervention when the primary therapy was declared a failure.
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	Intention‐to‐treat principle applied
Selective reporting (reporting bias)	Low risk	Trial protocol was published (NCT00734227). Reported protocol's predetermined outcomes
Other bias	Low risk	Study sponsored by institutional grant