PROPHYLACTIC SCLEROTHERAPY FOR ESOPHAGEAL-VARICES IN HIGH-RISK CIRRHOTIC-PATIENTS SELECTED BY ENDOSCOPIC AND HEMODYNAMIC CRITERIA - A RANDOMIZED, SINGLE-CENTER CONTROLLED TRIAL

Controlled trials of sclerotherapy for the prevention of the first var iceal hemorrhage in cirrhotics have given conflicting results, in spit e of an initial positive controlled trial. We designed therefore a new study in which only 89 of 396 investigated patients were randomized t o sclerotherapy (44 patients) or a control group (45 patients). The ad mission criteria were: no history of variceal bleeding, the presence o f high risk varices, i.e., varices of degrees III and IV with minivari ces on the surface of them, and portal pressure over 16 mmHg. Scleroth erapy sessions were performed at 0, 7, 14, 21, and 28 days, until the varices were reduced in size and completely covered by fibrous tissue. Follow-up endoscopy was performed at four-month and thereafter at six -month intervals. The control patients underwent repeated clinical inv estigation and endoscopy at six-month intervals. Bleeding episodes wer e treated by emergency endoscopic sclerotherapy in both groups, whenev er possible. The mean follow-up was 33 months. The results were analyz ed using Student's t-test and the log-rank test. Variceal bleeding occ ured in 11 sclerotherapy patients (25 %) and 34 controls (75.6 %) (p<0 .05). The overall mortality was 25 % (11 patients) among the sclerothe rapy patients and 69 % (31 patients) in the controls (p<0.01). Prophyl actic endoscopic sclerotherapy was able to prolong survival in Child-P ugh classes A and B, but not in C. It is concluded that prophylactic e ndoscopic sclerotherapy does reduce the incidence of first variceal bl eeding in cirrhotic patients, and is able to prolong survival if only high-risk patients are selected and the treatment is performed by endo scopic experts.