Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study,☆☆,,★★

Presented in abstract form at the Annual Meeting of American Gastroenterological Association, May 14-17, 1995, San Diego, California (Gastroenterology 1995;108:A424.)
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Abstract

Background: There is a lack of multicenter prospective studies on complications of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (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 complications were predefined. Data were collected at the time of ERCP, before discharge, 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 combination. 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 there were 98 major complications (5.4%) and 9 deaths (0.49%). The difference in the incidence of complications between diagnostic and therapeutic ERCPs was statistically significant (p < 0.0001). Small center and precut were recognized as independent risk factors for overall major complications of therapeutic ERCP, whereas the following risk factors were identified in relation to specific complications: (1) pancreatitis: age less than 70 years, pancreatic duct opacification, and nondilated common bile duct; (2) cholangitis: small center, jaundice; (3) hemorrhage: small center; and (4) retroperitoneal duodenal perforation: precut, intramural injection of contrast medium, and Billroth II gastrectomy. Conclusions: Major complications are mostly associated with therapeutic procedures and low case volume. Present data support a policy of centralization of ERCP in referral centers. A more selected and safer use of precut may be expected to further limit the adverse events of ERCP. (Gastrointest Endosc 1998;48:1-10.)

Section snippets

PATIENTS AND METHODS

As a part of a program of quality assurance, a prospective study on major ERCP complications was carried out from February 1, 1992, to January 31, 1994, under the auspices of the Triveneto Section of the Italian Society for Digestive Endoscopy. Triveneto includes three economically and socially developed regions in northeast Italy: Veneto, Trentino Alto Adige, and Friuli Venezia Giulia, with about 100 public general hospitals serving a population of 6,534,626 and at least 30 endoscopy units

RESULTS

The number of candidate-independent patients undergoing ERCP in single units ranged from 45 to 449 per year and ERCPs were performed either by a single operator or by a team of no more than three endoscopists. Three centers performed ERCP on less than 100 patients per year (range 45 to 78), three between 100 and 150 (range 127 to 148), and three on more than 200 (range 203 to 449). For purposes of comparative analysis, the last three were named large centers, and the other six were named small

DISCUSSION

Most studies on ERCP complications have been specifically devoted to sphincterotomy, the highest risk procedure routinely performed by endoscopists, whereas data on diagnostic ERCP are limited. A large retrospective U.S. survey by Male et al.9 did not find a statistically significant difference between diagnostic and therapeutic ERCP in the incidence of severe complications and in mortality. A different finding resulted from a British survey involving ten centers in a single region,10 where

Acknowledgements

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Acknowledgements

We thank Professor Nib Soehendra, University Hospital of Hamburg (Germany), and Professor Lajos Okolicsanyi, Chair of Gastroenterology, University of Parma (Italy), for helpful discussion and advice.

References (40)

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From the S.I.E.D. (Italian Society for Digestive Endoscopy) Triveneto Study Group on ERCP Complications: Ospedali di Treviso, Verona (Policlinico e Maggiore) , Bolzano, Belluno, Pordenone, Trento, Noale (Padua), Villafranca (Verona), and Glaxo Wellcome Research Center, Verona, Italy.

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Supported in part by a grant from the Triveneto Section of the Italian Society for Digestive Endoscopy.

Reprint requests: Silvano Loperfido, MD, Servizio di Gastroenterologia, ed Endoscopia Digestiva, Ospedale ULSS 9, 31100 Treviso, Italy.

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