Henderson 1990.
| 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: biopsy proven cirrhosis, endoscopic evidence of varices and suitability for a DSRS shunt established with angiography. Exclusions (one or more of the following): living more than 200 miles from the base hospital, referred for specific therapy, previous chronic sclerotherapy, emergent or urgent surgery, noncirrhotic variceal bleed. Patients comparable in‐terms of age, Child's class and alcoholics. |
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| Interventions | ET:
Sclerotherapy, intra‐variceal and para‐variceal technique, sclerosant: 0.75 ‐1.0% sodium tetradecyl sulfate or 1.5 ‐2.0% sodium morrhuate. Shunt: DSRS (Warren). |
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| Outcomes | Survival. Rebleeding. Hepatic function. Hemodynamics and liver and spleen volumes. | |
| Notes | Encephalopathy not considered as an outcome. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |