title: Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.
abstract: BACKGROUND
  Emergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS).
  
  
  METHODS
  Two hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years.
  
  
  RESULTS
  Direct charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed.
  
  
  CONCLUSIONS
  In this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis.
authors.affiliation: Department of Surgery, University of California, San Diego Medical Center, 200 West Arbor Drive, San Diego, CA 92103-8999, USA. morloff@ucsd.edu
authors.forename: Marshall J
authors.initials: MJ
authors.lastname: Orloff
authors.forename: Jon I
authors.initials: JI
authors.lastname: Isenberg
authors.forename: Henry O
authors.initials: HO
authors.lastname: Wheeler
authors.forename: Kevin S
authors.initials: KS
authors.lastname: Haynes
authors.forename: Horacio
authors.initials: H
authors.lastname: Jinich-Brook
authors.forename: Roderick
authors.initials: R
authors.lastname: Rapier
authors.forename: Florin
authors.initials: F
authors.lastname: Vaida
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hye
mesh_terms: D003365:Costs and Cost Analysis; D004180:Direct Service Costs; D016099:Endoscopy, Gastrointestinal / Q000191:economics*; D004932:Esophageal and Gastric Varices / Q000209:etiology / Q000628:therapy*; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000628:therapy*; D017048:Health Care Costs; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D008875:Middle Aged; D011167:Portacaval Shunt, Surgical / Q000191:economics* / Q000379:methods; D012189:Retrospective Studies; D015911:Sclerotherapy / Q000191:economics* / Q000379:methods; D014481:United States
references.citation: Curr Med Res Opin. 2007 Jul;23(7):1745-7
references.pmid: 17588304
references.citation: Ann Surg. 2009 Oct;250(4):598-610
references.pmid: 19730244
references.citation: J Am Coll Surg. 2009 Jul;209(1):25-40
references.pmid: 19651060
references.citation: Med Decis Making. 1993 Oct-Dec;13(4):322-38
references.pmid: 8246705
references.citation: World J Surg. 2005 Aug;29(8):966-73
references.pmid: 15981047
references.citation: N Engl J Med. 1987 Jan 1;316(1):11-5
references.pmid: 3491317
references.citation: Ann Intern Med. 2001 Apr 17;134(8):663-94
references.pmid: 11304107
references.citation: J Hepatol. 2008 Mar;48(3):407-14
references.pmid: 18045724
references.citation: Am J Gastroenterol. 2003 Nov;98(11):2424-34
references.pmid: 14638344
references.citation: Ann Intern Med. 1982 Jan;96(1):102-9
references.pmid: 7053682
references.citation: Ann Surg. 2003 Jun;237(6):820-5; discussion 825-7
references.pmid: 12796578
references.citation: Clin Liver Dis. 2006 Aug;10(3):679-89, xi
references.pmid: 17162235
references.citation: JAMA. 2001 Apr 18;285(15):1987-91
references.pmid: 11308435
references.citation: Hepatology. 1999 Jan;29(1):44-50
references.pmid: 9862848
references.citation: Gastroenterology. 2006 May;130(6):1643-51
references.pmid: 16697728
references.citation: Ann Intern Med. 1997 Jun 1;126(11):858-65
references.pmid: 9163286
references.citation: Endoscopy. 2006 Aug;38(8):797-807
references.pmid: 17001564
references.citation: J Gastrointest Surg. 2010 Nov;14(11):1782-95
references.pmid: 20658205
references.citation: Hepatology. 2007 Apr;45(4):870-8
references.pmid: 17393528
references.citation: N Engl J Med. 1984 Dec 20;311(25):1589-94
references.pmid: 6334234
references.citation: Surgery. 1997 Oct;122(4):794-9; discussion 799-800
references.pmid: 9347858
references.citation: J Am Coll Surg. 1995 Mar;180(3):257-72
references.pmid: 7874335