Background
Methods
Selection criteria
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 |
Assessment of study quality
Reference | Randomization | Blinding | Withdrawals and dropouts | Jadad score |
---|---|---|---|---|
[4] | Centralized randomization schedule | Double blinding | Clearly reported | 5 |
[9] | Computer-generated list | Double blinding | Clearly reported | 5 |
[8] | Computer-generated list | Double blinding | Clearly reported | 5 |
[7] | Computer-generated randomized set of numbers | Double blinding | Clearly reported | 5 |
Statistical analysis
Results
Primary outcome
Secondary outcome
Sensitivity-analysis
Outcome | Meta-analysis | Sensitivity-analysis I | Sensitivity-analysis II | |||
---|---|---|---|---|---|---|
OR | P | OR | P | OR | P | |
PEP | 0.67 (0.31, 1.47) | 0.32 | 0.99 (0.64, 1.54) | 0.97 | 0.51 (0.17, 1.51) | 0.22 |
Post-ERCP hyperamylasemia | 0.88 (0.72, 1.07) | 0.20 | 0.88 (0.70, 1.11) | 0.29 | 0.87 (0.70, 1.09) | 0.22 |
Post-ERCP abdominal pain | 0.69 (0.39, 1.21) | 0.19 | 0.86 (0.60, 1.22) | 0.39 | 0.59 (0.28, 1.25) | 0.17 |