P‐Layrargues 2001.
Methods | Randomised trial.
A. Generation of allocation sequence: unclear. Randomisation mentioned but method not specified.
B. Allocation concealment: unclear. No information.
C. Blinding: no information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding to randomisation: After patients had been haemodynamically stabilised for 24 hours. TIPS (hours): 44. ET (hours): 42. Time from randomisation to Traitement for TIPS (mean): 13 hours. 158 patients evaluated, reasons provided for those excluded: yes. 39 included in the ET group and 41 in the TIPS group. Follow‐up period in days (mean). TIPS: 678. ET: 581. Assessment of suitability for shunt carried out prior to randomisation: Yes. Shunt patency assessed with duplex scanning at 24 hours and then 3 monthly. Two patients in the TIPS group and four in the ET underwent transplantation, one patient crossed over from ET to TIPS. Intention‐to‐treat analysis. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing: clinical. Rebleeding episodes endoscopically verified: yes. Specified whether clinically significant : yes. |
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Participants | Inclusion criteria: cirrhosis, Child‐Pugh grade B and C, age between 18 to 75 years, with an episode of endoscopically verified variceal bleeding. Exclusions: portal vein thrombosis, previous endoscopic therapy within three months, previous shunt, fundal varices, hepatocellular carcinoma, cardiac, renal or respiratory failure, non‐compliance, sepsis, and uncontrolled bleeding. |
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Interventions | ET:
Variceal band ligation. Shunt: TIPS (type not specified). |
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Outcomes | Survival. Rebleeding. Encephalopathy. Shunt dysfunction. Duration of hospital stay. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |