Sauer 1997.
Methods | Randomised trial.
A. Generation of allocation sequence: adequate. Computer generated random numbers.
B. Allocation concealment: unclear. No information.
C. Blinding: unclear. No information.
D. Follow‐up: adequate.
Inclusion of all randomised participants at evaluation: yes. Time from bleeding episode to randomisation in days (SD): 1.1 days (1.1). Time from randomisation to treatment in days (SD): 3.4 (2.8) Total number of patients evaluated and found eligible: 98. Randomised to TIPS: 42, randomised to ET: 41. Adequate reasons provided for those not randomised: yes. No losses to follow‐up. Five patients in ES group crossed over to TIPS during follow‐up. Intention‐to‐treat analysis. Assessment of suitability for shunt carried out prior to randomisation = yes. Shunt patency assessed with Duplex ultrasound or angiography at three monthly intervals. Method of Child's grading: Child‐Pugh. Method of encephalopathy testing: clinical and trail making test. Rebleeding episodes endoscopically verified: yes. Specified whether rebleeding episode clinically significant: yes. Median observation time in years TIPS (1.6) ET (1.4) Assessment of suitability for shunt carried out prior to randomisation = not mentioned. Shunt patency assessed with Duplex ultrasound and angiography at three monthly intervals. Method of Child's grading = Child‐Pugh. Method of encephalopathy testing = clinical and trail‐making tests. Rebleeding episodes endoscopically verified = yes. Specified whether rebleeding episode clinically significant = no. |
|
Participants | Inclusion criteria: cirrhosis and acute oesophageal haemorrhage. Exclusions (one or more of the following): gastric varices, prior endoscopic or surgical treatment for varices, portal venous thrombosis, hepatoma, end‐stage cancer or systemic disease which would limit the patients life span to less than six months and uncontrolled bleeding requiring an emergency TIPS procedure. Slightly younger patients in the TIPS group. |
|
Interventions | ET:
Sclerotherapy plus propranolol, sclerotherapy intra‐variceal and para‐variceal technique, sclerosant = 5% ethanolamine oleate. Shunt: TIPS (Palmaz stent). |
|
Outcomes | Rebleeding. Mortality. Encephalopathy. Complications. | |
Notes | Propranolol used in‐addition to sclerotherapy. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |