Does the Gabexate Mesilate Product Against ERCP Related Pancreatic Damage?

초록

Background and Aim Recent studies have reported that prophylactic treatment with gabexate mesilate (GM) is effective in preventing endoscopic retrograde cholangiopancreatography (ERCP)-related pancreatic injury. However, there is ongoing debate about its cost-effectiveness when 1 g of GM is administered to all patients undergoing ERCP. Furthermore, it has not been established whether the preventive effect of GM on ERCP-related pancreatic injury is dose-dependent. The aim of this study was to evaluate the effectiveness of a low dose of GM in preventing ERCP-related pancreatic injury. Methods This prospective study included 102 consecutive patients scheduled for ERCP (68 in the GM group and 34 in the placebo group). GM (500 mg) was administered intravenously, starting 30 minutes before ERCP and continued for 12 hours afterward. The control group received normal saline using the same protocol. Serum amylase and lipase levels were measured before ERCP and at 4, 8, and 24 hours after the procedure. Hyperenzymemia was defined as an elevation of serum amylase and/or lipase above the upper normal limit within 24 hours after ERCP. ERCP-related pancreatitis was defined as abdominal pain with an elevation of serum amylase and/or lipase more than three times the upper normal limit. The incidence of hyperenzymemia and pancreatitis, as well as changes in serum enzyme levels, were analyzed between the two groups according to various parameters, including difficulty of duct cannulation, visualization of the pancreatic duct, performance of therapeutic procedures, and total procedure time. Results The overall incidence of ERCP-related hyperenzymemia was not significantly reduced by GM treatment (45.6% in the GM group vs. 55.9% in the control group). The overall incidence of acute pancreatitis was low (1.0%) in this study and was not affected by GM treatment. Difficulty of duct cannulation, visualization of the pancreatic duct, performance of therapeutic procedures, and longer procedure time were associated with an increased incidence of hyperenzymemia. However, GM treatment did not reduce the rate of hyperenzymemia under any of these conditions. Conclusion Prophylactic treatment with 500 mg of gabexate mesilate offers no advantage in preventing ERCP-related pancreatic injury. These results suggest that the preventive effect of GM may be dose-dependent. Considering cost-effectiveness, further randomized studies are needed to determine selective indications for prophylactic treatment with high-dose GM.

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