MAJOR EARLY COMPLICATIONS FROM DIAGNOSTIC AND THERAPEUTIC ERCP - A PROSPECTIVE MULTICENTER STUDY

Background: There is a lack of multicenter prospective studies on comp lications of diagnostic and therapeutic endoscopic retrograde cholangi opancreatography (ERCP). Methods: We studied 2769 consecutive patients undergoing ERCP at nine centers in the Triveneto region of Italy over a 2-year period. Six centers performed ERCP on less than 200 patients per year (small centers). General and ERCP-specific major complicatio ns were predefined. Data were collected at the time of ERCP, before di scharge, and in cases of readmission within 30 days. ERCP was defined as therapeutic when endoscopic sphincterotomy (n = 1583), precut (n = 419), or drainage (n = 701) had been carried out, singularly or in com bination. Results: One hundred eleven major complications (4.0%) were recorded: moderate-severe pancreatitis 36 (1.3%), cholangitis 24 (0.87 %), hemorrhage 21 (0.76%), duodenal perforation 16 (0.58%), others 14 (0.51%). Among 942 diagnostic ERCPs there were 13 major complications (1.38%) and 2 deaths (0.21%), whereas among 1827 therapeutic ERCPs the re were 98 major complications (5.4%) and 9 deaths (0.49%).The differe nce in the incidence of complications between diagnostic and therapeut ic ERCPs was statistically significant (p < 0.0001). Small center and precut were recognized as independent risk factors for overall major c omplications of therapeutic ERCP, whereas the following risk factors w ere identified in relation to specific complications: (1) pancreatitis : age less than 70 years, pancreatic duct opacification, and nondilate d common bile duct; (2) cholangitis: small center, jaundice; (3) hemor rhage: small center; and (4) retroperitoneal duodenal perforation: pre cut, intramural injection of contrast medium, and Billroth II gastrect omy. Conclusions: Major complications are mostly associated with thera peutic procedures and low case volume. Present data support a policy o f centralization of ERCP in referral centers. A more selected and safe r use of precut may be expected to further limit the adverse events of ERCP.