Clinical trial of gabexate in the prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis.
The objective of the present study was to determine the efficacy of prophylactic administration of gabexate for the prevention of post-endoscopic 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.
Xiong
G-S
GS
Department of Gastroenterology, Renji Hospital, Shanghai Second Medical University, Shanghai, People's Republic of China.
Wu
S-M
SM
Zhang
X-W
XW
Ge
Z-Z
ZZ
D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control*; D000208:Acute Disease; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D016670:Gabexate / Q000008:administration & dosage*; D006801:Humans; D034321:Hyperamylasemia / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D015842:Serine Proteinase Inhibitors / Q000008:administration & dosage*
D015842:Serine Proteinase Inhibitors; D016670:Gabexate