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. 2006 Oct 18;2006(4):CD000553. doi: 10.1002/14651858.CD000553.pub2

Gulberg 2002.

Methods Randomised trial. 
 A. Generation of allocation sequence: unclear. No information. 
 B. Allocation concealment: adequate. Sealed, opaque envelopes. 
 C. Blinding: unclear. No information. 
 D. Follow‐up: adequate. 
 Inclusion of all randomised participants at evaluation: yes.
Time from bleeding episode to randomisation (mean, SD) = TIPS 13, 3(days), ET 14, 3 (days). Time from randomisation to treatment = unclear. 
 Total number of patients evaluated = 86 
 Randomised to TIPS = 28, randomised to ET = 26. 
 Adequate reasons provided for those not randomised = yes. 
 Two patients did not receive the allocated treatment in TIPS group and six patients in ET group were crossed over to TIPS and one to a surgical shunt during follow‐up. 
 Follow‐up period in years (mean) 
 TIPS 1.8 
 ET 2 . 
 Assessment of suitability for shunt carried out prior to randomisation = yes. 
 Shunt patency assessed with Duplex scanning. 
 Method of Child's grading = Child‐Pugh, patients were stratified according to the Child‐Pugh system. 
 Method of encephalopathy testing = clinical. 
 Rebleeding episodes endoscopically verified = yes. 
 Specified whether rebleeding episode clinically significant = yes.
Participants Inclusion criteria: age > 18 years, endoscopic evidence of variceal bleeding within 2 months before randomisation, stable heamodynamic condition.
Exclusion criteria: isolated gastric varices, isolated bleeding from gastric varices, large or diffuse liver tumour, liver transplantation intended in six months, hepatic encephalopathy > grade 2, Child Pugh >13, extra hepatic cholestasis, heart failure, sepsis, multi‐organ failure.
Interventions ET: 
 Variceal band ligation.
TIPS: 
 Expandable 8‐10 mm stents.
Outcomes Rebleeding. 
 Death. 
 Treatment failure.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate