Henderson 2006.

Methods	Randomised clinical trial (DIVERT Study)
Participants	Country: USA Number randomised: 140 participants Analysis: intention‐to‐treat Age: mean age 53 ± 10 years for DSRS, and 52 ± 1 years for TIPS Initial endoscopic assessment, including therapy before randomisations Duration of follow‐up: 8 years Inclusion criteria Endoscopically proven variceal bleeding secondary to liver cirrhosis of any aetiology Diagnosis of liver cirrhosis by clinical and laboratory data Child‐Pugh class A or B cirrhosis Suitability for intervention confirmed by ultrasound and angiography Failed endoscopic therapy (sclerotherapy or banding), defined as bleeding sufficient to produce hypotension, or transfusion requirement of three units per bleed, or recurrent bleeds not requiring transfusion, or participants who are not candidates for endoscopic therapy Exclusion criteria Aetiology of varices other than cirrhosis Bleeding from portal hypertensive gastropathy Prior shunt procedure Medically intractable ascites Renal insufficiency with creatinine greater than 2 Age less than 18 years Portal vein thrombosis Polycystic liver disease Child‐Pugh score greater than 9 Right heart failure Prominent cause of liver cirrhosis: alcohol‐related
Interventions	Distal splenorenal shunt (n = 73) versus TIPS (n = 67) Only uncovered stents of variable sizes from 8 mm to 12 mm used for TIPS Intervention performed within five days of randomisation
Outcomes	Primary outcomes: variceal rebleeding, and encephalopathy Secondary outcomes: mortality, ascites, shunt stenosis and thrombosis, need for liver transplantation, liver tests, quality of life, and cost
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised. 'Randomisation' was controlled by a central data co‐ordinating centre
Allocation concealment (selection bias)	Low risk	Treatment allocation achieved with use of "a variable 2 or 4 permuted block size design, stratifying by Child‐Pugh class A and B, and alcoholic and nonalcoholic patients". By randomly varying the block sizes, treatment allocation could not be predicted towards the end of a block.
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 interventions 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	Low risk	The Clinical Endpoint Review Committee received summary data on all outcomes in a blinded manner from the data co‐ordinating centre. Blinding of outcome assessors judged as adequate
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 (NCT00006161). Reported all protocol predefined outcomes
Other bias	Low risk	Study sponsored by institutional grant