Cello 1997.

Methods	Randomised trial. A. Generation of allocation sequence: unclear. No information. B. Allocation concealment: adequate. Sealed, 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 (mean, SD) = TIPS (35.4,5.6 hours), ET (37.4, 4.7 hours). Time from randomisation to treatment (mean, SD) = TIPS ( 59.5, 6.7 hours). Total number of patients evaluated = 300. Randomised to TIPS = 24, randomised to ET = 25. Adequate reasons provided for those not randomised. Reasons mentioned but numbers not provided. One patient did not receive the allocated treatment in TIPS group and six patients in ET group were crossed over to TIPS during follow‐up. Follow‐up period in days (mean, SD) TIPS (575, 109) ET (567, 104) Assessment of suitability for shunt carried out prior to randomisation = yes. Shunt patency assessed with Duplex scanning. Method of Child's grading = Child‐Pugh, however, patients were not stratified according to the Child‐Pugh system. Method of Encephalopathy testing = clinical. Rebleeding episodes endoscopically verified = yes. Specified whether rebleeding episode clinically significant = not stated.
Participants	Inclusion criteria: all patients admitted with massive or submassive acute gastrointestinal tract haemorrhage from large oesophageal varices. Exclusions (one or more of the following): prisoners, <18 or >75 years of age, Cerebrovascular accident three months before the onset of bleeding, refusal to accept blood products, gastric variceal haemorrhage, ECG changes compatible with myocardial infarction, specified limits of PO2, creatinine, bilirubin, prothrombin time and platelet count measurements, Grade IV encephalopathy, cancer other than skin cancer, AIDS, sepsis, pneumonia, peritonitis, alcoholic hepatitis (clinical evidence only), thrombosis of portal, hepatic or inferior vena cava. Patients across the two strata were comparable in‐terms of age, child score and alcoholics.
Interventions	ET: Sclerotherapy, para‐variceal technique, sclerosant = ethanolamine oleate. Shunt: TIPS (wall stents).
Outcomes	Rebleeding. Encephalopathy. Survival. Cost analysis.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate