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. |
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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. |
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Interventions | ET:
Variceal band ligation. TIPS: Expandable 8‐10 mm stents. |
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Outcomes | Rebleeding. Death. Treatment failure. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |