Rosemurgy 2012.
Methods | Randomised clinical trials | |
Participants | Country: USA Number randomised: 132 participants Intention‐to‐treat analysis Mean age 54 ± 14 years for H‐shunt and 55 ± 12 years for TIPS Maximal duration of follow‐up: 18 years Inclusion criteria Child‐Pugh A, B, C cirrhosis and portal hypertension with variceal or portal gastropathy bleeding who have failed or not candidates for endoscopic therapy. Median MELD score 13 Exclusion criteria Participants with unfavourable anatomy or unlikely to survive because of profound ill‐health or hepatic dysfunction were excluded. |
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Interventions | TIPS (66), H‐graft shunt 8mm (66) Intervention performed as a definitive procedure, never as a bridge to transplantation |
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Outcomes | Mortality, variceal rebleeding, shunt occlusion, liver failure requiring transplantation, inability to accomplish shunting, ascites, and encephalopathy | |
Notes | Shunt failure was referred to as mortality, variceal rebleeding, irreversible shunt occlusion, liver failure requiring transplantation, and inability to accomplish shunting. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised randomisation by parallel allocation |
Allocation concealment (selection bias) | Low risk | Computer generated sequential allocation |
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 were blinded to the intervention received. The surgeon was only blinded to the type of shunt to be assigned. Given the nature of the interventions, it was unrealistic to blind participants to the intervention received |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Personnel were blinded to the intervention received. "A senior faculty hepatologist/gastroenterologist was "blinded" to the intervention received and evaluated participants for encephalopathy during the clinic visits". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat principle used for data analysis |
Selective reporting (reporting bias) | Low risk | Trial protocol was not found but predetermined outcomes in methods section were all reported |
Other bias | Low risk | Trial supported by institutional grant |