Skip to main content
. 2006 Oct 18;2006(4):CD000553. doi: 10.1002/14651858.CD000553.pub2

Cello 1987.

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).
Participants Inclusion criteria: Child's C patients with actively bleeding varices confirmed on endoscopy, requiring six or more units of blood transfusion.
Exclusions: moribund patients. Pre‐treatment variables were comparable across the two groups other than active alcoholics which were significantly greater in the ES group.
Interventions ET: 
 Sclerotherapy, intra‐variceal technique, sclerosant = sodium morrhuate.
Shunt: 
 Portocaval shunt.
Outcomes Rebleeding. 
 Encephalopathy. 
 Survival. 
 Cost.
Notes Only 16 patients in the shunt group and 14 in the ET group discharged after the index hospitalisation.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk A ‐ Adequate