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

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.
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.
Interventions ET: 
 Variceal band ligation.
Shunt: 
 TIPS (type not specified).
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