Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study.
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.
Manes
Gianpiero
G
Department of Gastroenterology, University Hospital L. Sacco, Milano, Italy.
Ardizzone
Sandro
S
Lombardi
Giovanni
G
Uomo
Generoso
G
Pieramico
Oreste
O
Porro
Gabriele Bianchi
GB
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
D015842:Serine Proteinase Inhibitors; D016670:Gabexate