PROSPECTIVE RANDOMIZED TRIAL OF EMERGENCY PORTACAVAL-SHUNT AND EMERGENCY MEDICAL THERAPY IN UNSELECTED CIRRHOTIC-PATIENTS WITH BLEEDING VARICES

A prospective randomized trial was conducted in unselected, consecutiv e patients with bleeding esophageal varices resulting from cirrhosis c omparing (1) emergency portacaval shunt performed within 8 hr of initi al contact (21 patients) with (2) emergency medical therapy (intraveno us vasopressin and esophageal balloon tamponade) followed in 9 to 30 d ays by elective portacaval shunt in survivors (22 patients). All patie nts underwent the same diagnostic workup within 3 to 6 hr of initial c ontact, and received identical supportive therapy initially. All patie nts were followed up for at least 10 yr. The protocol contained no esc ape or crossover provisions. There were no statistically significant d ifferences between the two treatment groups in the incidence of any of the clinical variables, results of laboratory tests or degree of port al hypertension. Child's risk classes in the shunt group were A-2 pati ents, B-8 patients and C-ll patients, whereas in the medical group the y were A-1O patients, B-5 patients, and C-7 patients, a significant di fference (p < 0.01) that might have favored emergency medical treatmen t. Bleeding was controlled initially and permanently by emergency shun t in every patient, but by medical therapy in only 45% (p < 0.001), Me an re quirement for blood transfusion was 7.1 +/- 2.6 units in the shu nt group and 21.4 +/- 2.6 units in the medical group (p < 0.001). Eigh ty-one percent of the patients in the shunt group were discharged aliv e compared with 45% in the medical group (p = 0.027). Five- and 10-yr observed survival rates were 67% and 57%, respectively, after emergenc y shunt compared with 18% and 18%, respectively, after the combination of emergency medical therapy and elective shunt (p < 0.01). These sur vival rates produced by emergency shunt performed within 8 hr of initi al contact confirm the effectiveness of this procedure observed in our previous unrandomized studies.