Liver transplantation in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis

M. J. Orloff, J. I. Isenberg, H. O. Wheeler, K. S. Haynes, H. Jinich-Brook, R. Rapier, F. Vaida, R. J. Hye, Susan Orloff

Research output: Contribution to journalArticle

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Abstract

Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST; n = 106) to emergency direct portacaval shunt (EPCS; n = 105). Methods Diagnostic work-up and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter; 96% underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100% follow-up. Results In the RCT long-term bleeding control was 100% following EPCS, only 20% following EST. Also, 3-, 5-, 10-, and 15-year survival rates were 75%, 73%, 46%, and 46%, respectively, following EPCS compared with 44%, 21%, 9%, and 9% following EST, respectively (P <.001). Only 13 RCT patients (6%) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3%) were approved for LT and only 4 (2%) underwent LT. The 1- and 5-year LT survival rates were 0.68% and 0, respectively, compared with 81% and 73%, respectively, after EPCS. In the 1300 unrandomized PCS patients, 50 (3.8%) were referred and 19 (1.5%) underwent LT. The 5-year survival rate was 53% compared with 72% for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy.

Original languageEnglish (US)
Pages (from-to)4101-4108
Number of pages8
JournalTransplantation Proceedings
Volume42
Issue number10
DOIs
StatePublished - Dec 2010

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Emergency Treatment
Esophageal and Gastric Varices
Liver Transplantation
Surgical Portacaval Shunt
Fibrosis
Randomized Controlled Trials
Hemorrhage
Survival Rate
Emergencies
Sclerotherapy
Liver Failure
Therapeutics
Mortality

ASJC Scopus subject areas

  • Surgery
  • Transplantation

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Liver transplantation in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis. / Orloff, M. J.; Isenberg, J. I.; Wheeler, H. O.; Haynes, K. S.; Jinich-Brook, H.; Rapier, R.; Vaida, F.; Hye, R. J.; Orloff, Susan.

In: Transplantation Proceedings, Vol. 42, No. 10, 12.2010, p. 4101-4108.

Research output: Contribution to journalArticle

Orloff, M. J. ; Isenberg, J. I. ; Wheeler, H. O. ; Haynes, K. S. ; Jinich-Brook, H. ; Rapier, R. ; Vaida, F. ; Hye, R. J. ; Orloff, Susan. / Liver transplantation in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis. In: Transplantation Proceedings. 2010 ; Vol. 42, No. 10. pp. 4101-4108.
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abstract = "Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST; n = 106) to emergency direct portacaval shunt (EPCS; n = 105). Methods Diagnostic work-up and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter; 96{\%} underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100{\%} follow-up. Results In the RCT long-term bleeding control was 100{\%} following EPCS, only 20{\%} following EST. Also, 3-, 5-, 10-, and 15-year survival rates were 75{\%}, 73{\%}, 46{\%}, and 46{\%}, respectively, following EPCS compared with 44{\%}, 21{\%}, 9{\%}, and 9{\%} following EST, respectively (P <.001). Only 13 RCT patients (6{\%}) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3{\%}) were approved for LT and only 4 (2{\%}) underwent LT. The 1- and 5-year LT survival rates were 0.68{\%} and 0, respectively, compared with 81{\%} and 73{\%}, respectively, after EPCS. In the 1300 unrandomized PCS patients, 50 (3.8{\%}) were referred and 19 (1.5{\%}) underwent LT. The 5-year survival rate was 53{\%} compared with 72{\%} for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy.",
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AU - Orloff, M. J.

AU - Isenberg, J. I.

AU - Wheeler, H. O.

AU - Haynes, K. S.

AU - Jinich-Brook, H.

AU - Rapier, R.

AU - Vaida, F.

AU - Hye, R. J.

AU - Orloff, Susan

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N2 - Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST; n = 106) to emergency direct portacaval shunt (EPCS; n = 105). Methods Diagnostic work-up and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter; 96% underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100% follow-up. Results In the RCT long-term bleeding control was 100% following EPCS, only 20% following EST. Also, 3-, 5-, 10-, and 15-year survival rates were 75%, 73%, 46%, and 46%, respectively, following EPCS compared with 44%, 21%, 9%, and 9% following EST, respectively (P <.001). Only 13 RCT patients (6%) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3%) were approved for LT and only 4 (2%) underwent LT. The 1- and 5-year LT survival rates were 0.68% and 0, respectively, compared with 81% and 73%, respectively, after EPCS. In the 1300 unrandomized PCS patients, 50 (3.8%) were referred and 19 (1.5%) underwent LT. The 5-year survival rate was 53% compared with 72% for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy.

AB - Background Bleeding esophageal varices (BEV) in cirrhosis has been considered an indication for liver transplantation (LT). This issue was examined in a randomized controlled trial (RCT) of unselected, consecutive patients with advanced cirrhosis and BEV that compared endoscopic sclerotherapy (EST; n = 106) to emergency direct portacaval shunt (EPCS; n = 105). Methods Diagnostic work-up and treatment were initiated within 8 hours. Patients were evaluated for LT on admission and repeatedly thereafter; 96% underwent over 10 years of regular follow-up. The analysis was supplemented by 1300 unrandomized cirrhotic patients who previously underwent portacaval shunt (PCS) with 100% follow-up. Results In the RCT long-term bleeding control was 100% following EPCS, only 20% following EST. Also, 3-, 5-, 10-, and 15-year survival rates were 75%, 73%, 46%, and 46%, respectively, following EPCS compared with 44%, 21%, 9%, and 9% following EST, respectively (P <.001). Only 13 RCT patients (6%) were ultimately referred for LT mainly because of progressive liver failure; only 7 (3%) were approved for LT and only 4 (2%) underwent LT. The 1- and 5-year LT survival rates were 0.68% and 0, respectively, compared with 81% and 73%, respectively, after EPCS. In the 1300 unrandomized PCS patients, 50 (3.8%) were referred and 19 (1.5%) underwent LT. The 5-year survival rate was 53% compared with 72% for all 1300 patients. Conclusions If bleeding is permanently controlled, as occurred invariably following EPCS, cirrhotic patients with BEV seldom require LT. PCS is effective first-line and long-term treatment. Should LT be required in patients with PCS, although technically more demanding, numerous studies have shown that PCS does not increase mortality or complications. EST is not effective emergency or long-term therapy.

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