title: Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study.
abstract: OBJECTIVE
  Gabexate mesylate reduces the incidence of post-ERCP pancreatitis. Patient-related risk factors associated with pancreatitis can be identified before ERCP, but the procedure-related factors are recognized only at the end of the procedure. This study's aim was to evaluate whether gabexate mesylate administered after ERCP reduces the incidence of pancreatitis.
  
  
  METHODS
  Randomized, prospective, double-blind, multicenter trial.
  
  
  METHODS
  Tertiary care centers.
  
  
  METHODS
  A total of 608 patients undergoing ERCP were treated with gabexate mesylate 500 mg within 1 hour before ERCP (group A, 203 patients) or within 1 hour after ERCP (group B, 203), or with saline solution (group C, 202).
  
  
  METHODS
  The incidence and severity of pancreatitis and hyperamylasemia, as well as factors associated with the development of pancreatitis.
  
  
  RESULTS
  The groups were similar for demographic characteristics, indications to ERCP, risk factors for pancreatitis, and therapeutic procedures. The incidence of pancreatitis was 3.9% in group A, 3.4% in group B, and 9.4% in group C (P<.01). Two patients (in groups A and C) developed necrotizing pancreatitis, and 1 died. Hyperamylasemia occurred in 23.6% in groups A and B, and in 24.7% in group C. Levels of amylase, the incidence of abdominal pain, and other complications occurred similarly. Female sex (odds ratios [OR] 2.7, 95% CI 1.2-5.9) and difficult cannulation (OR 5.6, 95% CI 2.6-12.3) were independently associated with pancreatitis.
  
  
  CONCLUSIONS
  The administration of gabexate mesylate after ERCP protects against the development of pancreatitis similarly to the preprocedure administration. Factors associated with pancreatitis were mainly recognized after ERCP. We suggest administering gabexate mesylate after ERCP only in those patients recognized to be at risk of developing pancreatitis.
authors.affiliation: Department of Gastroenterology, University Hospital L. Sacco, Milano, Italy.
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Manes
authors.forename: Sandro
authors.initials: S
authors.lastname: Ardizzone
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lombardi
authors.forename: Generoso
authors.initials: G
authors.lastname: Uomo
authors.forename: Oreste
authors.initials: O
authors.lastname: Pieramico
authors.forename: Gabriele Bianchi
authors.initials: GB
authors.lastname: Porro
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D016670:Gabexate / Q000008:administration & dosage*; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications; D011446:Prospective Studies; D012307:Risk Factors; D015842:Serine Proteinase Inhibitors / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects / Q000379:methods; D016896:Treatment Outcome
chemical_list: D015842:Serine Proteinase Inhibitors; D016670:Gabexate