TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT VERSUS ENDOSCOPIC SCLEROTHERAPY FOR THE PREVENTION OF VARICEAL BLEEDING IN CIRRHOSIS - A RANDOMIZED MULTICENTER TRIAL

Transjugular intrahepatic portosystemic shunt (TIPS), a new technique for the treatment of portal hypertension, has been successful in preli minary studies to treat acute variceal hemorrhage and to prevent varic eal rebleeding. The purpose of this multicenter, randomized controlled trial is to compare the efficacy of TIPS with that of endoscopic scle rotherapy in the prevention of variceal rebleeding in cirrhosis. Eight y-one cirrhotic patients, with endoscopically proven variceal bleeding , were randomized to either TIPS (38 patients) or endoscopic sclerothe rapy (43 patients). Randomization was stratified according to the foll owing: if bleeding occurred < 1 week (stratum I); if bleeding: occurre d 1 to 6 weeks (stratum II); and if bleeding occurred 6 weeks to 6 mon ths (stratum III) before enrollment. Follow-up included clinical, bioc hemical, Doppler Ultrasound, and endoscopic examinations every 6 month s. During a mean follow-up of 17.7 months, 51% of the patients treated with sclerotherapy and 24% of those treated with TIPS rebled (P = .01 1). Mortality was 19% in sclerotherapy patients and 24% in TIPS patien ts (P = .50). Hepatic encephalopathy (HE) developed in 26% and 55%, re spectively (P = .006). A separate analysis of the three strata showed that TIPS was significantly more effective than sclerotherapy (P = .02 6) in preventing rebleeding only in stratum I patients. TIPS is signif icantly better than sclerotherapy in preventing rebleeding only when i t is performed shortly after a variceal bleed; however, TIPS does not improve survival and is associated with a significantly higher inciden ce of HE. The overall performance of TIPS does not seem to justify the adoption of this technique as a first-choice treatment to prevent reb leeding from esophageal varices in cirrhotic patients.