Endoscopic sclerotherapy v. conservative management of bleeding oesophageal varices. A 5-year prospective controlled trial of emergency and long-term treatment.

A comparative trial was made of conservative therapy (balloon tamponade and/or vasopression infusion) alone (control group) or with addition of acute and serial endoscopic injection sclerotherapy (ST group). The 107 unselected patients, mainly with alcoholic cirrhosis, were randomly allocated to these groups, which were comparable as regards Child's grading and clinical and laboratory findings. For emergency ST a fibreoptic endoscope and Williams sheath were used. In initial control of index bleed and hospital mortality the two groups did not differ significantly. The median follow-up was 15 and 28 months (minimum 1 year). Supplementary ST (mainly out-patient) gave variceal eradication in 34 of 41 patients, with most failures in persistent alcoholics. A calculated risk factor for rebleeds was 3.6 times higher in the controls than in the ST group. Mortality rate showed no intergroup difference. The cause of death mainly was variceal bleeding in the controls, but not in the ST group. Major complications of treatment occurred in c. 15% of all patients.

RCT Entities:   Population Interventions Outcomes