Liver Transplantation during Fifty-Three Years’ Experience with Randomized Controlled Trials of Emergency Portacaval Shunt for Bleeding Esophageal Varices in Cirrhosis

Abstract

Background: Currently, emergency treatment of Bleeding Esophageal Varices (BEV) consists mainly of endoscopic and pharmacologic measures, with use of TIPS when bleeding is not controlled. Surgical shunt has been relegated to salvage of survivors of failed endoscopic, pharmacologic, and TIPS treatment. We have conducted 10 prospective studies of Emergency Porta Caval Shunt (EPCS) during 46 years. BEV in cirrhosis has been considered an indication for Liver Transplantation (LT) by some respected LT programs. This important issue was examined in our two recent Randomized Controlled Trials (RCTs) in 365 unselected, consecutive patients with acute BEV conducted from 1988 to 2011. Study design: In RCT No. 1, 211 unselected, consecutive cirrhotic patients with acute BEV ("all comers") were randomized to Emergency Endoscopic Sclerotherapy (EEST) (n=106) or EPCS (n=105). In RCT No. 2, 154 unselected consecutive cirrhotic patients with acute BEV ("all comers") were randomized to TIPS (n=78) or EPCS (n=76). In each RCT, the two treatment groups were compared with regard to effect on survival, control of bleeding, encephalopathy, and direct cost of care. Diagnostic workup was completed within 6 hr and primary treatment was initiated within 8 to 12 hours. Regular follow-up was accomplished in 100% of patients. In RCT No. 1, 96% of patients underwent more than 10 years of follow-up, or until death. In RCT No. 2, follow-up lasted for 5 to 10 years in 85%, and 3 to 4.5 years in the remainder. Patients were evaluated for LT on admission and at regular intervals thereafter. In addition to the two RCTs, the analysis of LT was supplemented in 1300 unrandomized cirrhotic patients who previously underwent Porta Caval Shunt (PCS) with 100% follow-up. Results: Clinical characteristics of each group were similar at the time of enrollment. The distribution of patients in Child risk classes was almost identical in the two groups in each RCT. Almost one-third of patients in each group were in Child class C. Permanent control of bleeding was achieved by sclerotherapy in only 20% and by TIPS in only 22%. In contrast, EPCS permanently controlled bleeding in 97% to 100% (p<0.001). Sclerotherapy and TIPS patients required twice as many units of blood transfusion as EPCS patients. Survival rate at all time intervals and in all Child classes was significantly greater following EPCS than after sclerotherapy and TIPS (p<0.001). Median survival was over 10 years following EPCS, compared to 1.99 years following TIPS. EPCS remained permanently patent in 97% of patients. In contrast, stenosis or occlusion of TIPS was demonstrated in 84% of patients, 63% of whom underwent TIPS revision, which failed in 80%. Recurrent episodes of encephalopathy developed in 35% of sclerotherapy patients and 61% of TIPS patients. In contrast, encephalopathy occurred in 15% of EPCS patients in RCT No. 1 and 21% of EPCS patients in RCT No. 2. Direct costs of care, measured as charges per year, were 5 to 7 times greater in the sclerotherapy group ($168,100) and TIPS groups ($...

Transplantation: Unbelievable Evolution and an Amazing Gift to Human Population

“…The only curative treatment options for hepatocellular carcinoma are liver resection and liver transplantation in now a day [19]. Bleeding esophageal varices in cirrhosis have been considered an indication for liver transplantation by some respected liver transplantation programs [20].…”