Nahara 2001.
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, S.D) = TIPS (19.1,2 days), ET (17.9,1.9). Time from randomisation to treatment (mean, SD) = Not clear. Total number of patients evaluated = 101 Randomised to TIPS = 38, randomised to ET = 40. Adequate reasons provided for those not randomised = yes. One patient in ET group crossed over to TIPS during follow‐up. Follow‐up period in days (mean, SD) TIPS (1116,92) ET (1047,102) Assessment of suitability for shunt carried out prior to randomisation = no. Shunt patency assessed with Duplex scanning. Method of Child's grading = Child‐Pugh, however, patients were not stratified according to the Child‐Pugh system. Method of Encephalopathy testing = Parson Smith criteria. Rebleeding episodes endoscopically verified = yes. Specified whether rebleeding episode clinically significant = not stated. |
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Participants | Inclusions: cirrhosis with recent variceal haemorrhage, clinical stability at randomisation, age between 20 to 69 years. Exclusion criteria: hepatocellular carcinoma, episodes of chronic encephalopathy, portal vein thrombosis, Child‐Pugh > 13, serum creatinine >2.5 milligram per decilitre, serum bilirubin > 5 milligram per decilitre, active infection and severe cardiopulmonary disease. |
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Interventions | ET: Sclerotherapy using 5% ethanolamine TIPS: Rosch‐Uchida as well as wall stents (8 to 10 mm). | |
Outcomes | Rebleeding. Death. Hepatic encephalopathy. Complications. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |