TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTS COMPARED WITH ENDOSCOPIC SCLEROTHERAPY FOR THE PREVENTION OF RECURRENT VARICEAL HEMORRHAGE -A RANDOMIZED, CONTROLLED TRIAL

Background: Transjugular intrahepatic portosystemic shunts (TIPS) have widened the use of portal decompression as therapy for variceal hemor rhage. However, no controlled studies have examined the efficacy of TI PS compared with that of other treatments. Objective: To compare the e fficacy and safety of TIPS with those of endoscopic sclerotherapy for the prevention of recurrent variceal hemorrhage. Design: Randomized, c ontrolled trial. Setting: Tertiary-care academic medical center. Patie nts: 100 patients with cirrhosis were evaluated a mean of approximatel y 10 days after an episode of acute variceal bleeding; 20 patients wer e excluded because of portal venous thrombosis (n = 6), hepatoma (n = 3), florid alcoholic hepatitis (n = 6), and refusal to give consent (n = 5). Interventions: TIPS (n = 41) or sclerotherapy (n = 39). The lat ter was performed by freehand injections of 5% Na morrhuate at 2- to 3 -week intervals. Recurrent variceal hemorrhage was managed by scleroth erapy followed by angiographic assessment of TIPS and dilatation of th e stents (TIPS group) or crossover to TIPS (sclerotherapy group). Meas urements: Rebleeding and survival were the primary end points. Complic ations and rates of rehospitalization were secondary end points. Resul ts: During a mean follow-up of approximately 1000 days, recurrent gast rointestinal bleeding resulted from variceal hemorrhage (9 patients in the TIPS group and 8 in the sclerotherapy group), portal gastropathy (1 patient in each group), and gastric lipoma (0 and 1 patients, respe ctively). A higher mortality rate was seen with TIPS (P = 0.03). Death resulted from variceal bleeding (5 patients in the TIPS group and 3 i n the sclerotherapy group), sepsis (3 and 2 patients, respectively), l iver failure (2 patients in each group), hepatoma (1 and 0 patients, r espectively), and hemoperitoneum (1 and 0 patients, respectively). Enc ephalopathy was the most common complication in the TIPS group (n = 12 ), and pain developing after sclerotherapy was the most common in the sclerotherapy group (n = 10). The two groups had similar rates of reho spitalization. Conclusions: Endoscopic sclerotherapy and TIPS are equi valent with respect to rebleeding developing over the long term. Howev er, sclerotherapy may be superior to TIPS with respect to survival.