OBJECTIVES: To provide health-care providers, patients, and physicians with an exhaustive assessment of prospective studies on rates of complications and fatalities associated with endoscopic retrograde cholangiopancreatography (ERCP). METHODS: We searched MEDLINE (1977-2006) for prospective surveys on adult patients undergoing ERCP. "Grey literature" was sought by looking at cited references to identify further relevant studies. Data on postprocedural pancreatitis, bleeding, infections, perforations, and miscellaneous events as well as their associated fatalities were extracted independently by two reviewers. Sensitivity analysis was performed to test for data consistency between multicenter versus single center studies, and old (1977-1996) versus recent (1997-2005) reports. RESULTS: In 21 selected surveys, involving 16,855 patients, ERCP-attributable complications totaled 1,154 (6.85%, CI 6.46-7.24%), with 55 fatalities (0.33%, CI 0.24-0.42%). Mild-to-moderate events occurred in 872 patients (5.17%, CI 4.83-5.51%), and severe events in 282 (1.67%, CI 1.47-1.87%). Pancreatitis occurred in 585 subjects (3.47%, CI 3.19-3.75%), infections in 242 (1.44%, CI 1.26-1.62%), bleeding in 226 (1.34%, CI 1.16-1.52%), and perforations in 101 (0.60%, CI 0.48-0.72%). Cardiovascular and/or analgesia-related complications amounted to 173 (1.33%, CI 1.13-1.53%), with 9 fatalities (0.07%, CI 0.02-0.12%). As compared with old reports, morbidity rates increased significantly in most recent studies: 6.27% versus 7.51% (Pc = 0.029). CONCLUSIONS: ERCP remains the endoscopic procedure that carries a high risk for morbidity and mortality. Complications continue to occur at a relatively consistent rate. The majority of events are of mild-to-moderate severity.
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