title: Randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic shunt versus portacaval shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis.
abstract: OBJECTIVE
  Bleeding esophageal varices has been studied extensively, but bleeding gastric varices (BGV) has received much less investigation. However, BGV has been reported in ≤ 30% of patients with acute variceal bleeding. In our studies of 1,836 bleeding cirrhotics, 12.7% were bleeding from gastric varices. BGV mortality rate of 45-55% has been reported. The BGV literature has mainly involved retrospective case reports, often with short-term follow-up.
  
  
  OBJECTIVE
  We sought to describe the results of a prospective, randomized, controlled trial (RCT) in unselected, consecutive patients with BGV comparing endoscopic therapy (ET) with portacaval shunt (PCS; n = 518), and later comparing emergency transjugular intrahepatic portosystemic shunt (TIPS) with emergency portacaval shunt (EPCS; n = 70).
  
  
  METHODS
  Initially, our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding, mortality rate, and disability. When entry of patients ended, the RCT was expanded to compare emergency TIPS with EPCS (n = 70). This RCT of BGV was separate from our other RCTs of bleeding esophageal varices.
  
  
  METHODS
  Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS).
  
  
  METHODS
  Outcomes were survival, control of bleeding, portal-systemic encephalopathy (PSE), quality of life, and direct costs of care. In the RCT of ET versus PCS, 28 and 30%, respectively, were in Child class C. In the expanded RCT of TIPS versus EPCS, 40 and 41%, respectively, were in Child class C. Permanent control of BGV was achieved in 97-100% of patients treated by emergency or elective PCS, compared with 27-29% by ET. TIPS was even less effective, achieving long-term control of BGV in only 6%. Survival rates after PCS were greater at all time intervals and in all Child classes (P < .001). Repeated episodes of PSE occurred in 50% of TIPS patients, 16-17% treated by ET, and 8-11% treated by PCS. Shunt stenosis or occlusion occurred in 67% of TIPS patients, in contrast with 0-2% of PCS patients.
  
  
  CONCLUSIONS
  These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
authors.affiliation: Department of Surgery, University of California, San Diego Medical Center, San Diego, CA. Electronic address: morloff@ucsd.edu.
authors.forename: Marshall J
authors.initials: MJ
authors.lastname: Orloff
authors.affiliation: Department of Surgery, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Hye
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Henry O
authors.initials: HO
authors.lastname: Wheeler
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Jon I
authors.initials: JI
authors.lastname: Isenberg
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Kevin S
authors.initials: KS
authors.lastname: Haynes
authors.affiliation: Department of Family and Preventive Medicine/Biostatistics and Bioinformatics, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Florin
authors.initials: F
authors.lastname: Vaida
authors.affiliation: Department of Surgery, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Girard
authors.affiliation: Department of Surgery, University of California, San Diego Medical Center, San Diego, CA.
authors.forename: Karen J
authors.initials: KJ
authors.lastname: Orloff
mesh_terms: D000328:Adult; D000368:Aged; D002140:California; D002423:Cause of Death; D018592:Cross-Over Studies; D017558:Elective Surgical Procedures / Q000379:methods* / Q000401:mortality; D004638:Emergency Treatment / Q000379:methods; D004724:Endoscopy / Q000379:methods / Q000401:mortality; D004932:Esophageal and Gastric Varices / Q000209:etiology / Q000401:mortality* / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006471:Gastrointestinal Hemorrhage / Q000209:etiology / Q000401:mortality / Q000601:surgery*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000150:complications* / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D011167:Portacaval Shunt, Surgical / Q000379:methods* / Q000401:mortality; D019168:Portasystemic Shunt, Transjugular Intrahepatic / Q000379:methods* / Q000401:mortality; D011446:Prospective Studies; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome