Cello 1987.
Methods | Randomised trial.
A. Generation of allocation sequence: unclear. No information.
B. Allocation concealment: adequate. Serially numbered opaque envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation, not mentioned. Time from randomisation to treatment: six hours for shunt and two hours for endoscopic treatment. Total number of patients evaluated: 68. Randomised to shunt: 32, randomised to ET: 32. Adequate reasons provided for those not randomised ‐ yes. Two patients in the shunt group did not receive the allocated treatment. No losses to follow‐up. Intention to treat analysis. Mean follow‐up period (range): 530 days mean, 21 to 1830 days. Assessment of suitability for shunt carried out prior to randomisation: no. Method of Child's grading: single worst Child’s criteria. Method of encephalopathy testing: clinical testing. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant = yes. (Only 16 patients in the shunt group and 14 in the ET group discharged alive after the initial hospitalisation). |
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Participants | Inclusion criteria: Child's C patients with actively bleeding varices confirmed on endoscopy, requiring six or more units of blood transfusion. Exclusions: moribund patients. Pre‐treatment variables were comparable across the two groups other than active alcoholics which were significantly greater in the ES group. |
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Interventions | ET:
Sclerotherapy, intra‐variceal technique, sclerosant = sodium morrhuate. Shunt: Portocaval shunt. |
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Outcomes | Rebleeding. Encephalopathy. Survival. Cost. | |
Notes | Only 16 patients in the shunt group and 14 in the ET group discharged after the index hospitalisation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |