Transjugular intrahepatic
portosystemic shunt (
TIPS), a new technique for the treatment of
portal hypertension, has been successful in preliminary studies to treat acute variceal
hemorrhage and to prevent variceal rebleeding. The purpose of this multicenter, randomized controlled trial is to compare the efficacy of
TIPS with that of endoscopic
sclerotherapy in the prevention of variceal rebleeding in
cirrhosis. Eighty-one cirrhotic patients, with endoscopically proven variceal
bleeding, were randomized to either
TIPS (38 patients) or endoscopic
sclerotherapy (43 patients). Randomization was stratified according to the following: if
bleeding occurred < 1 week (stratum I); if
bleeding occurred 1 to 6 weeks (stratum II); and if
bleeding occurred 6 weeks to 6 months (stratum III) before enrollment. Follow-up included clinical, biochemical, Doppler Ultrasound, and endoscopic examinations every 6 months. 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 = .011). Mortality was 19% in
sclerotherapy patients and 24% in
TIPS patients (P = .50).
Hepatic encephalopathy (HE) developed in 26% and 55%, respectively (P = .006). A separate analysis of the three strata showed that
TIPS was significantly more effective than
sclerotherapy (P = .026) in preventing rebleeding only in stratum I patients.
TIPS is significantly better than
sclerotherapy in preventing rebleeding only when it is performed shortly after a variceal bleed; however,
TIPS does not improve survival and is associated with a significantly higher incidence of HE. The overall performance of
TIPS does not seem to justify the adoption of this technique as a first-choice treatment to prevent rebleeding from
esophageal varices in cirrhotic patients.