Emergency Portacaval Shunt Versus Rescue Portacaval Shunt in a Randomized Controlled Trial of Emergency Treatment of Bleeding Esophageal Varices in Cirrhosis
Marshall J. Orloff*1, Jon I. Isenberg2, Henry O. Wheeler2, Kevin S. Haynes2, Horacio Jinich-Brook2, Roderick C. Rapier2, Florin Vaida3, Robert J. Hye1
1Surgery, University of California, San Diego, San Diego, CA; 2Medicine/Gastroenterology, University of California, San Diego, San Diego, CA; 3Family and Preventive Medicine/Biostatistics, University of California, San Diego, San Diego, CA
Background: Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of singular importance because of the high mortality rate. Emergency portacaval shunt (EPCS) is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that EPCS causes frequent portal-systemic encephalopathy (PSE) and liver failure. Consequently, portacaval shunt (PCS) has been relegated solely to salvage therapy when endoscopic and pharmacologic therapy have failed. Question: Is the regimen of endoscopic sclerotherapy (EST) with rescue PCS for failure to control BEV superior to EPCS? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy (EST) versus EPCS conducted from 1988 to 2005. Methods: Unselected, consecutive cirrhotic patients with acute BEV were randomized to EST (n=106) or EPCS (n=105). Diagnostic workup was completed and treatment was initiated within 8 hours. Failure of EST was defined by strict criteria and treated by rescue PCS (n=50) whenever possible. 96% of patients had more than 10 yr follow-up or until death. Results: See Table. Conclusions: EPCS was strikingly superior to EST as well as to the combination of EST and rescue PCS in regard to all outcome measures, specifically bleeding control, survival, incidence of PSE, improvement in liver function, quality of life, and cost of care. These results strongly support use of EPCS as the first line of emergency treatment of BEV in cirrhosis. (clinicaltrials.gov NCT00690027)
| Outcomes | EPCS n = 105 | EST-Rescue PCS | P |
| Bleeding control - % | 100 | EST - 0 Rescue PCS - 100 | <0.001 |
| PRBC units - mean | 17.83 | 27.80 | <0.001 |
| Survival % - 5 Yr | 72 | 22 | <0.001 |
| 10 Yr | 46 | 16 | <0.001 |
| 15 Yr | 46 | 0 | <0.001 |
| Median post-PCS survival | 6.18 yr | 1.99 yr | <0.001 |
| Recurrent PSE - % | 15 | 43 | <0.001 |
| 5-yr change in Child's class Improved - % Worse - % | 59 8 | 19 44 | <0.001 <0.001 |
| Quality of Life Points - mean (lower is better) | 13.89 | 27.89 | <0.001 |
| Mean cost of care per year | \,200 | \,700 | <0.001 |
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