Cabrera 1996.
| Methods | Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate. Inclusion of all randomised participants at evaluation: 1 patient from each group died before treatment and not included in the analysis. Time from bleeding episode to randomisation: Three days after bleeding was controlled. Time from randomisation to treatment in days (mean, SD): TIPS ( 8.4, 3.6), ET (2.7, 3.2). Total number of patients evaluated and found eligible: 63 (90 evaluated). Randomised to TIPS: 31, randomised to ET: 32. Adequate reasons provided for those not randomised: yes. Nine patients in the ET group crossed over to TIPS during follow‐up. There were no losses to follow‐up. Intention to treat analysis. Follow‐up period (mean days, SD) TIPS (452, 298) range: 20 to 020 days. ET (455, 298) range: 70 to 951 days. Assessment of suitability for shunt carried out prior to randomisation: no. Shunt patency assessed with angiography at six months or at the time of rebleeding. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing: clinical. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: yes. |
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| Participants | Inclusion criteria: all cirrhotic patients admitted with an episode of acute oesophageal variceal bleeding. Exclusions (one or more of the following): presence of gastric varices with active bleeding, episodes of chronic encephalopathy, severe acute alcoholic hepatitis, end‐stage cirrhosis, neoplastic disease, septicaemia and portal vein thrombosis. The two groups comparable in‐terms of age, Child's status and number of alcoholic patients. |
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| Interventions | ET:
sclerotherapy, intra‐ and para‐variceal technique, sclerosant = 1% polidocanol. Shunt: TIPS (wall and Strecker) |
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| Outcomes | Incidence of rebleeding. Incidence of complications. Incidence of deaths. | |
| Notes | Long‐term follow‐up published as abstract in Hepato‐Gastroenterology 1998, Third International Congress of Hepato‐Pancreato‐Biliary Association. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |