Randomized Trial of Emergency Endoscopic Sclerotherapy Versus Emergency Portacaval Shunt for Acutely Bleeding Esophageal Varices in Cirrhosis

Orloff, Marshall J.; Isenberg, Jon I.; Wheeler, Henry O.; Haynes, Kevin S.; Jinich-Brook, Horacio; Rapier, Roderick; Vaida, Florin; Hye, Robert J.

doi:10.1016/j.jamcollsurg.2009.02.059

« Previous Next »Journal of the American College of Surgeons
Volume 209, Issue 1 , Pages 25-40, July 2009

Randomized Trial of Emergency Endoscopic Sclerotherapy Versus Emergency Portacaval Shunt for Acutely Bleeding Esophageal Varices in Cirrhosis

Marshall J. Orloff, MD, FACS
- Department of Surgery, University of California, San Diego Medical Center, San Diego, CA
- Correspondence address: Marshall J Orloff, MD, UCSD Medical Center, 200 West Arbor Dr, San Diego, CA 92103–8999
Jon I. Isenberg, MD
- Department of Medicine/Gastroenterology, University of California, San Diego Medical Center, San Diego, CA
Henry O. Wheeler, MD
- Department of Medicine/Gastroenterology, University of California, San Diego Medical Center, San Diego, CA
Kevin S. Haynes, MD
- Department of Medicine/Gastroenterology, University of California, San Diego Medical Center, San Diego, CA
Horacio Jinich-Brook, MD
- Department of Medicine/Gastroenterology, University of California, San Diego Medical Center, San Diego, CA
Roderick Rapier, MD
- Department of Medicine/Gastroenterology, University of California, San Diego Medical Center, San Diego, CA
Florin Vaida, PhD
- Department of Family and Preventive Medicine/Biostatistics and Bioinformatics, University of California, San Diego Medical Center, San Diego, CA
Robert J. Hye, MD, FACS
- Department of Surgery, University of California, San Diego Medical Center, San Diego, CA

Received 16 December 2008; received in revised form 13 February 2009; accepted 16 February 2009. published online 01 May 2009.

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≤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≤0.001). Recurrent episodes of portal-systemic encephalopathy developed in 35% of EST patients and 15% of EPCS patients (p≤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).

Abbreviations and Acronyms: BEV, bleeding esophageal varices, EPCS, emergency portacaval shunt, EST, endoscopic sclerotherapy, EVL, endoscopic variceal ligation, PCS, portacaval shunt, PRBC, packed red blood cells, PSE, portal-systemic encephalopathy, TIPS, transjugular intrahepatic portal-systemic shunt, UCSD, University of California, San Diego, UGI, upper gastrointestinal