Clinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis

Abstract

The objective of the present study was to determine the efficacy of prophylactic administration of gabexate for the prevention of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, hyperamylasemia and pancreatic pain. Patients scheduled for ERCP were randomized into two groups in a double-blind manner: the patients in the gabexate group were treated with continuous intravenous infusion of 300 mg gabexate dissolved in 500 mL Ringer's solution at 111 mL/h, starting 30 min before the endoscopic maneuvers and continuing up to 4 h after them; placebo group patients were treated only with Ringer's solution also starting 30 min before the endoscopic maneuvers and continuing up to 4 h. Data for 193 patients were analyzed. The incidence of post-ERCP pancreatitis was 3 patients (3.1%) in the gabexate group and 10 (10.5%) in the placebo group (P = 0.040). The incidence of hyperamylasemia was 33 patients (33.7%) in the gabexate group and 42 (43.7%) in the placebo group (P = 0.133). The incidence of pancreatic pain was 15 patients (15.3%) in the gabexate group and 28 (29.5%) in the placebo group (P = 0.018). The results suggest that a 4.5-h infusion of gabexate (for a total of 300 mg) could prevent post-ERCP pancreatitis and pancreatic pain.

Comparison between ulinastatin and gabexate mesylate for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a prospective, randomized trial

“…Several randomized trials of these inhibitors have been published recently (Table 5). 3,[5][6][7][8][17][18][19][20] To date, however, very few reports comparing the effi cacy of ulinastatin and gabexate mesylate with regard to the prevention of post-ERCP pancreatitis have been published. 8,9 Meanwhile, Messmann et al 21 (4) the serum C-reactive protein level reached its peak 72 h after ERCP.…”

“…[1][2][3][4][5][6] Moreover, several articles published recently have reported the usefulness of ulinastatin for the prevention of post-ERCP pancreatitis. [7][8][9] A metaanalysis of studies related to the prevention of post-ERCP pancreatitis has suggested that administration of gabexate mesylate or somatostatin to all patients after ERCP is not economically justifi able and that it would be advisable to limit the use of these drugs to high-risk patients.…”

Protease inhibitors for preventing complications associated with ERCP: an updated meta-analysis

“…[37][38][39] Of the 28 articles, 18 met the inclusion criteria, [1][2][3][4][16][17][18][19][20][21][22][23][24][25][36][37][38][39] and no multiple publications were found. Agreement between reviewers regarding selection of relevant articles was 100%.…”

New advances in acute pancreatitis

“…In the past year several groups have re-investigated chemoprevention (N-acetylcysteine [40], octreotide [41,42], the protease inhibitors gabexate [43,44] and ulinastatin [44], and glyceryl trinitrate [45]) of post-ERCP pancreatitis either by RCTs or meta-analyses [46,47]. Milewski et al confirmed that N-acetylcysteine was ineffective [40].…”