Portal-Systemic Encephalopathy in a Randomized Clinical Trial of Endoscopic Sclerotherapy Versus Emergency Portacaval Shunt Treatment of Acutely Bleeding Esophageal Varices in Cirrhosis
Marshall J Orloff, *Jon I. Isenberg, *Henry O. Wheeler, *Kevin S. Haynes, *Horacio Jinich-Brook, *Roderick Rapier, *Florin Vaida, *Robert J. Hye
Univ. of California, San Diego, San Diego, CA
OBJECTIVE(S): It is widely believed that control of bleeding esophageal varices (BEV) by portal-systemic shunts is compromised by a high incidence of portal-systemic encephalopathy (PSE). This issue was examined by a randomized clinical trial that compared emergency and long-term endoscopic sclerotherapy (EST) (n=106) to emergency direct portacaval shunt (EPCS) (n=105).
METHODS: 211 unselected, consecutive patients with cirrhosis and acute BEV were randomized. EST or EPCS was initiated within 8 hours. PSE was quantitated by a “blinded” senior faculty gastroenterologist using 4 variously weighted components of PSE. All patients had follow-up for >9.4 years.
RESULTS: Child’s risk classes in the EST and EPCS groups, respectively, were: A-25% and 30%, B-43% and 47%, and C-26% and 29%. Control of bleeding was 21% following EST and 100% following EPCS (p=<0.001). EPCS survival was 3.5 to 5 times greater than EST survival up to 15-yr (p=<0.001). Incidence of recurrent PSE was 35% following EST and only 15% following EPCS (p=<0.001). PSE episodes and PSE hospital admissions, respectively, were 179 and 146 following EST versus 94 and 87 following EPCS (p<0.001). Recurrent UGI bleeding caused PSE in many EST patients.
CONCLUSIONS: In contrast to EST, EPCS permanently controlled BEV, produced greater long-term survival, and had a low incidence of PSE. These results were facilitated by lifelong follow-up, regular counseling on protein restriction, and long-term shunt patency. Furthermore, these results call into question the practice of avoiding portacaval shunt because of fear of PSE, and thereby foregoing the lifesaving advantage achieved by surgical control of bleeding.