VI. Adverse Events and Success of ERCPAdverse outcomes of ERCPā
Section snippets
Definitions of complications, adverse events, unplanned events and other negative outcomes
Consensus definitions for complications of sphincterotomy have been widely adopted since they were introduced in 1991 (Table 2).10 . Consensus definitions for the major complications of ERCP10Empty Cell Mild Moderate Severe Pancreatitis Clinical pancreatitis, amylase at least 3 times normal at more than 24 h after procedure, requiring admission or prolongation of planned admission to 2-3 d Pancreatitis requiring hospitalization of 4-10 d Hospitalization for more than 10 d, pseudocyst, or intervention (percutaneous
Variations in complication rates
Reported short-term complication rates vary widely. For example, reported rates of pancreatitis after diagnostic ERCP have been reported to vary from 0.74%22 to 5.2%.23 Reasons for such variation include (1) definitions used, for example, changing the threshold of amylase required to define pancreatitis10; (2) thoroughness of detection: prospective studies detect significantly more events than retrospective studies24; (3) patient-related factors: case mix often varies widely between centers;
Risk-factor analyses
Studies that use univariate analysis to identify risk factors for complications may produce misleading results because of inability to sort out confounding variables.25, 26, 27, 28, 29, 30 Recent studies have used multivariate analysis as a tool to identify and quantify the effect of multiple potentially confounding risk factors. However, even these studies may have important limitations because failure to evaluate important variables may allow surrogate or closely linked markers to appear as
Overall complications of ERCP and sphincterotomy
Short-term complications are reported to occur after 5% to 10% of ERCPs with or without sphincterotomy.10, 11, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48 Risk factors for overall and individual complications of ERCP and sphincterotomy are shown in Table 3, Table 4, Table 5. There is a particularly high rate of complications for sphincter of Oddi dysfunction and a relatively low complication rate for bile duct stone extraction.38
Pancreatitis
Rates of pancreatitis after ERCP and sphincterotomy range from less than 1% to 40%, but rates of 5% or more are typical.10, 11, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 35, 36, 37, 38, 39, 40, 42, 43, 44, 46, 47 There are many potential mechanisms of injury to the pancreas during ERCP and endoscopic sphincterotomy: mechanical, chemical, hydrostatic, enzymatic, microbiologic, and thermal, although the relative contribution of these mechanisms to post-ERCP pancreatitis is not known.23
Hemorrhage
Hemorrhage occurs primarily after sphincterotomy, with an incidence that varies widely depending on definitions, detection of delayed bleeding, patient factors, and endoscopic technique. Endoscopically observed bleeding is seen in about 10 to 30 percent of sphincterotomies, but does not by itself represent an adverse outcome to the patient.10, 38, 86 Clinically significant hemorrhage including melena or hematemesis or requiring intervention such as endoscopy or blood transfusion is much less
Perforation
Perforation may be retroperitoneal because of extension of a sphincterotomy incision beyond the intramural portion of the bile or pancreatic duct, intraperitoneal as a result of perforation of the bowel wall by the endoscope, or occur at any location because of extramural passage or migration of guidewires or stents. Perforation is now reported in less than 1% of ERCP and sphincterotomies.10, 11, 22, 23, 24, 25, 26, 27, 28, 29, 30, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47,
Cholangitis and cholecystitis
Cholangitis (bile duct infection) and cholecystitis (gallbladder infection) are potential complications or sequelae of ERCP and/or sphincterotomy.10 Risk factors for cholangitis after ERCP and sphincterotomy consist primarily of failed or incomplete biliary drainage45 and use of combined percutaneous-endoscopic procedures.38 Several studies have shown that prophylactic antibiotics can reduce the rate of bacteremia, but few studies have shown a reduction in clinical sepsis after ERCP, and a
Precut sphincterotomy
The use of precut sphincterotomy to gain bile duct access during ERCP is controversial. Principle techniques include needle-knife by the freehand technique58 with or without placement of a pancreatic stent64 (Table 3, Table 4), and the Erlangen pull-type papillotome technique.60 Some experts avoid precutting almost entirely whereas others use precutting for as many as 40% of all sphincterotomies and even for diagnostic ERCP. Complication rates of precut sphincterotomy have been reported to vary
Long-term complications/sequelae
Long-term sequelae of endoscopic biliary and pancreatic sphincterotomy and stent placement include recurrent stone formation, possibly resulting from sphincterotomy stenosis, or bacteriobilia caused by duodenal-biliary reflux, or āsine-materiaā cholangitis.12, 13, 14, 96 Recurrent stones and other biliary problems have been reported to occur from 6% to 24% of patients undergoing long-term follow-up after biliary sphincterotomy.12, 13, 14 Recurrent pancreatitis, presumably because of thermal
Training, experience, and ERCP outcomes
The effect of endoscopic training and expertise on outcomes of ERCP is profound, but is difficult to quantify as case mix, therapeutic intent, and technical success rates vary widely. It has been shown that in excess of 200 ERCPs are required for trainees to achieve a minimum goal of 80% success rates at selective biliary cannulation.99, 100 There are few data on the effect of training on complication rates. In accordance, the American Society for Gastrointestinal Endoscopy has recently raised
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Reprint requests: Martin L. Freeman, MD, Associate Professor of Medicine, University of Minnesota, Division of Gastroenterology, Hennepin County Medical Center, 701 Park Ave. South, Minneapolis, MN 55415.