Table 1 Randomized controlled trials on the use of gabexate for the prevention of pancreatic injury after ERCP
Reference | Setting | Sample size | Patient inclusion criteria | Interventions | Outcomes | Allocation concealment |
|---|---|---|---|---|---|---|
[4] | Italy multicentre | 418 | Patients over 18 years of age who were scheduled to undergo ERCP and, when indicated, endoscopic sphincterotomy | Gabexate 1 g given by intravenous infusion starting 30 to 90 minutes before endoscopy and continuing for 12 hours afterward | The incidence of PEP, post-ERCP hyperamylasemia, post-ERCP abdominal pain, case-fatality ratio of PEP | Adequate |
[9] | Italy multicentre | 396 | Patients over 18 years of age who were scheduled to undergo ERCP and, when indicated, endoscopic sphincterotomy with one of the following "high risk" factors: 1) a non-dilated (< 8 mm in diameter) bile duct on pre-ERCP US 2) a history of gallstone-induced or post-ERCP pancreatitis 3) suspected sphincter of Oddi dysfunction | Gabexate 500 mg given by intravenous infusion starting 30 minutes before endoscopy and continuing for 2 hours afterward | The incidence of PEP, severe PEP, post-ERCP hyperamylasemia, post-ERCP abdominal pain | Adequate |
[8] | Italy multicentre | 776 | Patients over 18 years of age who were scheduled to undergo ERCP and, when indicated, endoscopic sphincterotomy | Gabexate 500 mg given by intravenous infusion starting 30 before endoscopy and continuing for 6 hours afterward | The incidence of PEP, severe PEP, post-ERCP hyperamylasemia, post-ERCP abdominal pain, case-fatality ratio of PEP | Adequate |
[7] | China single centre | 193 | Patients over 18 years of age who were scheduled to undergo ERCP and, when indicated, endoscopic sphincterotomy | Gabexate 300 mg given by intravenous infusion starting 30 before endoscopy and continuing for 4.5 hours afterward | The incidence of PEP, post-ERCP hyperamylasemia, post-ERCP abdominal pain | Adequate |