Randomized trial of emergency endoscopic sclerotherapy versus emergency portacaval shunt for acutely bleeding esophageal varices in cirrhosis

Abstract

Background: The mortality rate of bleeding esophageal varices in cirrhosis is highest during the period of acute bleeding. This is a report of a randomized trial that compared endoscopic sclerotherapy (EST) with emergency portacaval shunt (EPCS) in cirrhotic patients with acute variceal hemorrhage.

Study design: A total of 211 unselected consecutive patients with cirrhosis and acutely bleeding esophageal varices who required at least 2 U of blood transfusion were randomized to EST (n=106) or EPCS (n=105). Diagnostic workup was completed within 6 hours and EST or EPCS was initiated within 8 hours of initial contact. Longterm EST was performed according to a deliberate schedule. Ninety-six percent of patients underwent more than 10 years of followup, or until death.

Results: The percent of patients in Child's risk classes were A, 27.5; B, 45.0; and C, 27.5. EST achieved permanent control of bleeding in only 20% of patients; EPCS permanently controlled bleeding in every patient (p< or =0.001). Requirement for blood transfusions was greater in the EST group than in the EPCS patients. Compared with EST, survival after EPCS was significantly higher at all time intervals and in all Child's classes (p< or =0.001). Recurrent episodes of portal-systemic encephalopathy developed in 35% of EST patients and 15% of EPCS patients (p< or =0.01).

Conclusions: EPCS permanently stopped variceal bleeding, rarely became occluded, was accomplished with a low incidence of portal-systemic encephalopathy, and compared with EST, produced greater longterm survival. The widespread practice of using surgical procedures mainly as salvage for failure of endoscopic therapy is not supported by the results of this trial (clinicaltrials.gov #NCT00690027).

Figure 1.

The overall design and conduct of the prospective randomized controlled trial is shown in a consort flow diagram.^, EPCS, emergency portacaval shunt; EST, endoscopic sclerotherapy.

Figure 2.

Kaplan-Meier estimates of overall survival after endoscopic sclerotherapy (EST) (n = 106) and emergency portacaval shunt (EPCS) (n = 105).

Figure 3.

Kaplan-Meier estimates of overall survival in Child’s risk classes A, B, and C after endoscopic sclerotherapy (EST) (n = 106) and emergency portacaval shunt (EPCS) (n = 105).