Frequency of post-ERCP pancreatitis in a single tertiary referral centre without and with routine prophylaxis with gabexate: A 6-year survey and cost-effectiveness analysis

Background and study aims: Several drugs have been used for the prevention of post-ERCP pancreatitis with conflicting results and no data referring to the routine use of a pharmacological prophylaxis have been published up to now. Aim of the study was to evaluate the frequency of post-ERCP pancreatitis and costs in a series of consecutive patients who have undergone ERCP procedures before and after the introduction of a routine prophylaxis with gabexate in all cases. Patients and methods: Data from 1312 patients who underwent ERCP procedures without gabexate prophylaxis and from 1149 consecutive patients with 1 g i.v. gabexate, were retrospectively evaluated during a 6-year period. Patients were also subdivided in standard- and high-risk subjects, on the basis of patient- and technique-related risk factors: 984 subjects (39.9%) had one or more conditions that placed them at high risk for post-ERCP pancreatitis. Results: Post-ERCP pancreatitis was reported in 76 out of 2461 patients (3.1%). The frequency of pancreatitis appeared significantly reduced in the gabexate period in comparison with before gabexate in overall cases (2.2% versus 3.9%; p = 0.019); however, the reduction was significant only for high-risk patients (3.8% versus 7.3%; p = 0.001). Severe hyperamylasaemia at 4-6 h and 24 h after the procedure was also significantly reduced only in high-risk patients (p = 0.001). Routine prophylaxis with gabexate appeared cost-effective in high-risk patients. Conclusions: Routine gabexate prophylaxis was associated with a significant reduction of post-ERCP pancreatitis rate, severe hyperamylasaemia and hospitalisation-related costs only in high-risk patients. However, gabexate appeared unable to reduce the incidence of severe pancreatitis.