Background and Study Aims: The aim of the present study was to analyze the risk factors
associated with complications of endoscopic sphincterotomy (ES).
Patients and Methods: In all consecutive endoscopic sphincterotomies carried out between
September 1994 and December 1996, the possible risk factors (12 patient-related factors
and 12 procedure-related ones), as well as the concomitant medical treatment, indications,
techniques, and success of endoscopic sphincterotomy were evaluated prospectively.
Risk factors were analyzed on an exploratory basis using univariate methods. “Potential
risk factors” (univariate, P < 0.1) underwent multivariate analysis to determine independent
“risk factors” (multivariate, P < 0.05). In addition, the complication rate was calculated
according to the number of potential risk factors present.
Results: A total of 438 patients who underwent ES were analyzed. Complications occurred
in 7.5 % (n = 33; acute pancreatitis 4.3 %, hemorrhage 2.3 %, cholangitis 0.9 %, technical
0.2 %). Statistical analysis of the complications identified three independent risk
factors (coagulopathy, patient age (≤ 60 years, pancreas divisum), and one protective
factor (pancreatic duct obstruction). The frequency of acute pancreatitis was increased
by two independent risk factors (pancreas divisum, ES frequency < 40 procedures/year)
and was reduced if low-dose anticoagulation (unfractionated heparin or low molecular
weight heparin) was administered (0.9 %, one of 115 vs. 5.8 %, 18 of 313; P < 0.05).
The effect of anticoagulation was not confounded by the presence or absence of other
potential risk factors for acute pancreatitis. Neither the risk nor the severity of
hemorrhage were increased by low-dose anticoagulation. Due to the low number of events,
only potential risk factors for hemorrhage were identified (coagulopathy, intensive-care
treatment). The overall complication rate and the incidence of pancreatitis and hemorrhage
increased significantly depending on the number of simultaneous potential risk factors
present (P < 0.0001).
Conclusions: Patients at risk for complications after endoscopic sphincterotomy can
be identified by risk factor analysis. These data suggest the hypothesis that low-dose
anticoagulation prior to endoscopic sphincterotomy reduces the risk of acute pancreatitis
after sphincterotomy.
References
Endoscopic papillotomy. In: Sivak MV (ed). Gastroenterologic endoscopy. Philadelphia; Saunders, 1987: 631-653
Statistical methods in medical research. 3rd ed . Oxford; Blackwell Science 1994: 311 Multiple comparison procedures. New York; Wiley, 1987 Applied logistic regression. New York; Wiley, 1989
Thomas.Rabenstein@med1.med.uni-erlangen.de
