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.
OBJECTIVE
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.


METHODS
Data from 1312 patients who underwent ERCP procedures without gabexate prophylaxis and from 1149 consecutive patients with 1g 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 4-6h and 24h 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.
Testoni
P A
PA
Division of Gastroenterology and Gastrointestinal Endoscopy, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Via Olgettina 60, 20132 Milan, Italy. testoni.pieralberto@hsr.it
Mariani
A
A
Masci
E
E
Curioni
S
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects* / Q000191:economics; D003362:Cost-Benefit Analysis; D003625:Data Collection; D005260:Female; D005500:Follow-Up Studies; D016670:Gabexate / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D034321:Hyperamylasemia / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D012017:Referral and Consultation; D012189:Retrospective Studies; D012307:Risk Factors; D015842:Serine Proteinase Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D016896:Treatment Outcome
D015842:Serine Proteinase Inhibitors; D016670:Gabexate; D000681:Amylases