Teres 1987.
| Methods | Randomised trial.
A. Generation of allocation sequence: adequate. Random number table.
B. Allocation concealment: adequate. Sealed envelopes.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation: 10 to 15 days. Time from randomisation to treatment in DSRS group in days: 11‐65. Total number of patients evaluated: 189. Randomised to SHUNT: 57, randomised to ET: 55. 14 patients in the shunt group and 55 patients in the endoscopic group did not receive the allocated treatment and were excluded, reasons provided. Two patients in the endoscopic group were lost to follow‐up. Mean follow‐up period in months (SD): shunt 27.45 (15.6), ES 26.5 (16.9). Follow‐up range in months DSRS (1‐58), ET (1‐64). Assessment of suitability for shunt carried out prior to randomisation: no. Method of Child's grading: Child‐Campbell. Method of encephalopathy testing: clinical testing and history. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: not specified. |
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| Participants | Inclusion criteria: Child‐Campbell A and B cirrhotic patients with at least one episode of variceal haemorrhage. Exclusions (one or more of the following): continual variceal bleeding despite medical treatment and early rebleeding between admission and randomisation. Child‐Campbell score greater and number of alcoholics greater in the ES group. |
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| Interventions | ET:
Sclerotherapy, technique ?intra‐variceal, sclerosant 5% ethanolamine oleate. Shunt: DSRS (retroperitoneal approach). |
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| Outcomes | Mortality. Rebleeding. Hepatic encephalopathy. Complications. Days of hospitalisation. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |
SD: standard deviation. SE: standard error of the mean. ITT: intention to treat. ET: endoscopic therapy. TS: total shunt. DSRS: distal splenorenal shunt. TIPS: transjugular intrahepatic porto‐systemic shunt. yrs: years.