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. |
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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. |
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Interventions | ET:
Sclerotherapy, ?intra‐variceal and para‐variceal technique, sclerosant = ethanolamine oleate. Shunt: TIPS (wall stent). |
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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 |