Sanyal 1997.
| Methods | Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated numbers.
B. Allocation concealment: adequate. Sealed opaque envelopes.
C. Blinding: unclear. Not mentioned.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation: Clinical stability for at least 72 hours following a variceal bleed. Time from randomisation to treatment: 72 hours. Total number of patients evaluated and found eligible: 100. Randomised to TIPS: 41, randomised to ET: 39. Adequate reasons provided for those not randomised = yes. Two patients lost to follow‐up in TIPS group and one in ET group. Six patients in ET group crossed over to TIPS during follow‐up. Five patients in the TIPS group and three in the ET group underwent hepatic transplantation. Intention to treat analysis. Follow‐up period in days (median) TIPS (990) ET (956). Assessment of suitability for shunt carried out prior to randomisation: yes. Shunt patency assessed with Duplex ultrasound at one week, one and three months and then every three months, angiography carried out at six monthly intervals. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing: not mentioned. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: yes. |
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| Participants | Inclusion criteria: clinical stability in the absence of re bleeding 72 hours following a variceal bleed. Exclusions (one or more of the following): portal venous thrombosis, hepatoma, end‐stage cancer or systemic disease which would limit the patients life span to less than one year. Patients slightly younger in the TIPS group. |
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| Interventions | ET:
Sclerotherapy, intra‐variceal technique, sclerosant sodium morrhuate (patients on beta‐blockade prior to randomisation were asked to stop taking it for the duration of the follow‐up period). Shunt: TIPS (wall stent). |
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| Outcomes | Rebleeding. Survival. Complications. Rates or re‐hospitalisations. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Low risk | A ‐ Adequate |