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

Garcia‐V 1999.

Methods Randomised trial. 
 A. Generation of allocation sequence: unclear. Randomisation mentioned, but method not specified. 
 B. Allocation concealment: unclear. No information. 
 C. Blinding: unclear. 
 D. Follow‐up: unclear. 
 Inclusion of all randomised participants at evaluation: exclusions less than 10%.
Time from variceal bleeding to therapy in days, mean (SD): TIPS 5.4 (2.1), ET 5.6 (2.2). 
 22 randomised in TIPS group and 24 in the ET group. 
 Follow‐up period in days mean (SD): 
 TIPS 760 (390), 
 ET 503 (460) 
 Assessment of suitability for shunt carried out prior to randomisation: not specified. 
 No cross‐overs, no information on attrition to follow‐up. 
 Shunt patency assessed with duplex scanning and portography at one month and then every six month. 
 Method of Child's grading: Child‐Pugh. 
 Method of encephalopathy testing: Parson‐Smith criteria. 
 Rebleeding episodes endoscopically verified: yes. 
 Specified whether rebleeding episode clinically significant: not specified.
Participants Inclusion criteria: endoscopically proven oesophageal variceal bleeding, diagnosis of cirrhosis based on clinical history and laboratory, ultrasonography, and/ or liver biopsy findings, age between 18 to 75 years and informed consent from the patient.
Exclusions (one or more of the following): history of chronic encephalopathy, portal vein thrombosis, hepatocellular carcinoma and end‐stage liver disease.
Comparable with respect to age, gender, etiology. Endoscopic group had a significantly greater proportion of patients with pre‐existing encephalopathy but were comparable in‐terms of Child‐Pugh class.
Interventions ET: 
 Sclerotherapy, ?intra‐variceal and para‐variceal technique, sclerosant = ethanolamine oleate.
Shunt: 
 TIPS (wall stent).
Outcomes Rebleeding. 
 Survival. 
 Encephalopathy. 
 Rebleeding index. 
 Days spent as an in‐patient. 
 Causes of death.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear