Predictors of complications after endoscopic retrograde cholangiopancreatography: a prognostic model for early discharge.

Abstract

Several studies have evaluated predictors for complications of endoscopic retrograde cholangiopancreatography (ERCP), but their relative importance is unknown. In addition, currently used blood tests to detect post-ERCP pancreatitis are inconsistent. The aim of this study was to determine predictors of post-ERCP complications that could discriminate between patients at highest and lowest risk of post-ERCP complications and to develop a model that is able to identify patients that can safely be discharged shortly after ERCP.
In a single-center, retrospective analysis over the period 2002-2007, predictors of post-ERCP complications were evaluated in a multivariable analysis and compared with those identified from a literature review. A prognostic model was developed based on these risk factors, which was further evaluated in a prospective patient population.
From our retrospective analysis and literature review, we selected the eight most important risk factors for post-ERCP pancreatitis and cholangitis. In the prognostic model, the risk factors (precut) sphincterotomy, sphincter of Oddi dysfunction, younger age, female gender, history of pancreatitis, pancreas divisum, and difficult cannulation accounted for a score of 1 each, whereas primary sclerosing cholangitis (PSC) accounted for a score of 2. A sum score of 4 or more in the prognostic model was associated with a high risk of developing pancreatitis and cholangitis (27%; 6/22) in the prospective patient population, whereas a sum score of 3 or less was associated with a low to intermediate risk (8%; 20/252).
We identified specific patient- and procedure-related factors that are associated with post-ERCP complications. The prognostic model based on these factors is able to identify patients who can be safely discharged the same day after ERCP.

Full text

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Predictors of complications after endoscopic retrograde
cholangiopancreatography: a prognostic model for early
discharge
S. M. Jeurnink•P. D. Siersema•E. W. Steyerberg•
J. Dees•J. W. Poley•J. Haringsma•E. J. Kuipers
Received: 25 July 2010/Accepted: 1 February 2011/Published online: 1 April 2011
? The Author(s) 2011. This article is published with open access at Springerlink.com
Abstract
Background
complications of endoscopic retrograde cholangiopancrea-
tography (ERCP), but their relative importance is unknown.
In addition, currently used blood tests to detect post-ERCP
pancreatitis are inconsistent. The aim of this study was to
determinepredictorsofpost-ERCPcomplicationsthatcould
discriminate between patients at highest and lowest risk of
post-ERCPcomplicationsandtodevelopamodelthatisable
toidentifypatientsthatcansafelybedischargedshortlyafter
ERCP.
Methods
In a single-center, retrospective analysis over
the period 2002–2007, predictors of post-ERCP compli-
cations were evaluated in a multivariable analysis and
compared with those identified from a literature review. A
prognostic model was developed based on these risk fac-
tors, which was further evaluated in a prospective patient
population.
Several studies have evaluated predictors for
Results
review, we selected the eight most important risk factors
for post-ERCP pancreatitis and cholangitis. In the prog-
nostic model, the risk factors (precut) sphincterotomy,
sphincter of Oddi dysfunction, younger age, female gender,
history of pancreatitis, pancreas divisum, and difficult
cannulation accounted for a score of 1 each, whereas pri-
mary sclerosing cholangitis (PSC) accounted for a score of
2. A sum score of 4 or more in the prognostic model was
associated with a high risk of developing pancreatitis and
cholangitis (27%; 6/22) in the prospective patient popula-
tion, whereas a sum score of 3 or less was associated with a
low to intermediate risk (8%; 20/252).
Conclusions
We identified specific patient- and proce-
dure-related factors that are associated with post-ERCP
complications. The prognostic model based on these fac-
tors is able to identify patients who can be safely dis-
charged the same day after ERCP.
From our retrospective analysis and literature
Keywords
Early discharge
ERCP ? Complications ? Risk factors ?
Endoscopic retrograde cholangiopancreatography (ERCP)
is a commonly performed procedure for the diagnosis and
treatment of biliary and pancreatic duct disorders. How-
ever, ERCP is associated with a relatively high complica-
tion rate. In published series, these rates vary between 0.8
and 45%, with pancreatitis occurring in 1–5%, cholangitis
in 1–5%, retroperitoneal perforation in 1–2%, and hemor-
rhage in 1% [1–7].
Several retrospective and prospective trials have evalu-
ated risk factors for post-ERCP complications. The relative
contribution of risk factors to morbidity and mortality after
ERCP, however, is unknown. Identification of these risk
S. M. Jeurnink ? P. D. Siersema ? J. Dees ?
J. W. Poley ? J. Haringsma ? E. J. Kuipers
Department of Gastroenterology and Hepatology, Erasmus
MC/University Medical Center Rotterdam, Rotterdam,
The Netherlands
E. W. Steyerberg
Department of Public Health, Erasmus MC/University Medical
Center Rotterdam, Rotterdam, The Netherlands
S. M. Jeurnink ? P. D. Siersema
Department of Gastroenterology and Hepatology, University
Medical Center Utrecht, Utrecht, The Netherlands
S. M. Jeurnink (&)
Department of Gastroenterology and Hepatology,
University Medical Center Utrecht, Heidelberglaan 100, 3584,
CX, Utrecht, The Netherlands
e-mail: s.m.jeurnink@students.uu.nl
123
Surg Endosc (2011) 25:2892–2900
DOI 10.1007/s00464-011-1638-9

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factors can, for example, be used to recognize patients at
highest risk for post-ERCP complications, for whom pre-
ventive endoscopic or pharmacologic measures and post-
procedural monitoring should be considered. Risk factors
may also aid in distinguishing patients at lowest risk for
complications as they are eligible for undergoing ERCP as
an outpatient procedure [1, 3–5, 8–14]. Early discharge can
lead to a decrease in the burden of ERCP for patients and
an overall cost reduction. So far, only Friedland et al. [14]
has presented a prognostic model that was able to predict
the risk of post-ERCP pancreatitis. However, this model
did not consider other common ERCP complications such
as cholangitis, hemorrhage, and perforation. In addition,
current blood tests, such as amylase and lipase levels for
pancreatitis, are inconsistent and do not aid sufficiently in
clinical decision-making on whether patients can safely be
discharged early after ERCP [15, 16].
The objective of this study was to examine risk factors
for post-ERCP complications, i.e., pancreatitis and cho-
langitis, that could aid clinicians in identifying high- and
low-risk patient groups for post-ERCP complications. We
compared the risk factors from a multivariable analysis in a
retrospectively collected single-center patient population
with those obtained from a literature review. In order to
determine which patients could safely be discharged after
ERCP, we developed a prognostic model for post-ERCP
pancreatitis and cholangitis and evaluated this in a pro-
spective patient population.
Materials and methods
Patients
For the retrospective analysis, we included all patients who
underwent ERCP in our center between January 2002 and
January 2007. For the prospective analysis, we included all
consecutive patients who underwent ERCP between April
2007 and April 2009. All data on patient and treatment
characteristics, complications, and mortality after ERCP
were collected. For the prospective analysis, complications
after discharge were evaluated by telephone interviews
with patients at 7 and 30 days after ERCP and by diaries
for pain and nausea scores. Patients who were referred
from other medical centers only for ERCP examination
were excluded from the analysis because of uncertainty
with regard to the completeness of the 30 day follow-up
data according to our strict protocol.
Procedure
The study setting was an academic tertiary referral center
with a liver transplant program and an ERCP volume
averaging between 650 and 800 ERCPs per year over the
last 10 years. All ERCP procedures were performed by
experienced endoscopists, generally assisted by a fellow-
trainee. A plain abdominal X-ray was made immediately
after the ERCP. All patients were admitted overnight fol-
lowing the procedure.
Systematic review
A systematic review of the literature was performed by
searching PubMed, EMBASE, the Cochrane Library, and
the Web of Science for the period January 1985-September
2009, using the following search terms: ERCP, pancreati-
tis, cholangitis, and hemorrhage. In addition, we checked
references of detected studies to identify additional rele-
vant reports. A total of 736 studies were found using these
search terms, of which 20 reported a univariable and/or
multivariable analysis of risk factors for post-ERCP com-
plications. One study was excluded because the relevant
data for calculating the confidence intervals was not
reported. Another study was excluded because it was not
available in the English language. Finally, a total of 18
studies was included [1, 3–6, 8, 10–14, 17–23].
Definitions
Procedure-related complications were defined as any event
occurring during the 30 day period after ERCP that nega-
tively affected the health status of patients for any period of
time and graded into categories of severity as proposed by
Cotton et al. [24]. Complications were defined according to
the literature as follows:
•
Pancreatitis: increased serum amylase concentration of
at least three times the normal level and occurring 24 h
or more after ERCP with concomitant new (or wors-
ening of) abdominal pain.
Cholangitis: fever due to (sub-) total obstruction of the
biliary system which was present for a minimum of
24 h after ERCP.
Hemorrhage: bleeding occurring during or shortly after
ERCP and associated with a hemoglobin drop of at
least 3 g/dl. Immediate minor hemorrhage was care-
fully observed, but this was not considered to be a
complication.
Perforation: radiological presence of contrast or air
outside the confines of the bile duct and duodenum
during or after ERCP and often seen on a plain
abdominal X-ray immediately after the procedure.
•
•
•
In patients with active pancreatitis or cholangitis at the
time of ERCP, symptoms compatible with these conditions
in the postprocedural phase of the study were not scored as
procedural complications. Similarly, when progression of
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the underlying disease resulted in death within 30 days
after ERCP, this was also considered to be unrelated to the
procedure [6]. The time after which complications occurred
was defined as the time that the first signs of pancreatitis,
cholangitis, hemorrhage, or perforation became clinically
evident.
Statistics
For the analysis of the retrospective series, explanatory risk
factors for complications identified in the reviewed litera-
ture were applied. We did not account for multiple pro-
cedures in the same patient. Logistic regression was
performed using Statistical Package for Social Science
program (SPSS 12.0.1, SPSS Inc., Chicago, IL). Factors
that had a P\0.5 in univariable analysis were entered into
a stepwise logistic regression model to estimate adjusted
odds ratios (ORs). In the multivariable analysis, a P\0.05
was considered to be significant.
Forest plots were constructed using ORs and 95% con-
fidence intervals (CIs) of risk factors for complications
when these were evaluated in more than two reviewed
studies. ORs were pooled and forest plots were created
using StatsDirect (StatsDirect statistical tools, StatsDirect
Ltd., UK). A Z test was used to test whether pooled ORs
differed from 1, indicating a significant effect on the
development of post-ERCP complications. A two-sided
P\0.05 was considered to be statistically significant.
Two experienced gastroenterologists, both performing
over 200 ERCPs annually, selected the most important risk
factors from the retrospective analysis and literature review
for post-ERCP pancreatitis and cholangitis to be included
in a prognostic model. Each risk factor in the prognostic
model was nominated a value that represented the magni-
tude of the effect on the development of pancreatitis or
cholangitis, based on the typical ORs. Risk factors were
evaluated using logistic regression in the prospective
patient population using SPSS software ver. 12.0.1.
A Kaplan–Meier curve was used to determine the time to
complications. A two-sided P\0.05 was considered sta-
tistically significant.
Results
Retrospective patient population
A total of 588 patients (58% male, mean age = 56.5 ±
17 years), who underwent a total of 1,372 ERCPs, were
includedinthispartofthestudy.CharacteristicsoftheERCP
procedures are presented in Table 1. A total of 76 (6%)
complications occurred after ERCP, of which pancreatitis
was seen in 34 (2%) procedures, cholangitis in 31 (2%),
perforation in 6 (0.4%), and hemorrhage in 5 (0.4%).
Uni- and multivariable analyses of the retrospective
population and systematic review
We found 12 risk factors that were significantly associated
with overall post-ERCP complications in our patient pop-
ulation in the univariable analysis (Table 2). In addition, 11
patient- and procedure-related risk factors for post-ERCP
pancreatitis (Table 3) and ten for cholangitis were identi-
fied (Table 4).
In the multivariable analysis, only primary sclerosing
cholangitis (PSC) (OR 2.2, CI 1.1–4.4) and sphincterotomy
(OR 2.2, CI 1.3–3.9) remained statistically significant for
overall post-ERCP complications. Pooled ORs from the
systematic review resulted in three statistically significant
risk factors for overall post-ERCP complications, i.e.,
suspected sphincter of Oddi dysfunction (SOD) (OR 2.6,
CI 2.0–3.3), precut sphincterotomy (OR 1.7, CI 1.5–2.0),
and female gender (OR 1.4, CI 1.2–1.5).
Significant risk factors for post-ERCP pancreatitis in the
multivariable analysis included pancreas divisum (OR
10.5, CI 1.0–112.8), PSC (OR 4.6, CI 1.8–11.5), age
\60 years (OR 4.9, CI: 1.2–19.6), and female gender (OR
2.1, CI 1.0–4.6). Pooled ORs from the systematic review
resulted in eight statistically significant risk factors for
post-ERCP pancreatitis, i.e., suspected SOD (OR 3.6, CI
2.3–5.3), history of post-ERCP pancreatitis (OR 1.9, CI
1.6–2.4), difficult cannulation (OR 2.5, CI 2.0–3.2), precut
sphincterotomy (OR 2.4, CI 1.8–3.2), pancreas divisum
(OR 2.2, CI 1.4–3.4), younger age (OR 2.0, CI 1.6–2.1),
Table 1 Characteristics of the ERCP procedure in a retrospective
patient population
Characteristics
N
Number of procedures1,372
Number of patients588
Diagnostic procedures199 (15%)
Failed procedures130 (10%)
First time ERCPs367 (27%)
Procedures
Sphincterotomy225 (16%)
Precut sphincterotomy74 (5%)
Plastic endoprosthesis placement702 (51%)
Metal stent placement52 (4%)
Balloon dilation of CBD130 (9%)
Removal of CBD stones 186 (14%)
Ampullary resection8 (1%)
CBD common bile duct
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female gender (OR 1.6, CI 1.3–1.8), and multiple pancre-
atic duct contrast injections (OR 1.6, CI 1.3–2.0).
In the multivariable analysis for post-ERCP cholangitis,
significant risk factors were self-expanding metal stent
(SEMS) placement (OR 3.9, CI 1.0–15.7) and sphincter-
otomy (OR 2.8, CI: 1.2–6.4). Pooled ORs from the sys-
tematic review resulted in four statistically significant risk
factors for post-ERCP cholangitis, i.e., jaundice at pre-
sentation (OR 4.8, CI 1.6–14.3), a small-volume center
(OR 4.7, CI 1.9–11.7), plastic stent placement (OR 3.1, CI
1.8–5.2), and female gender (OR 2.8, CI 1.2–6.6).
Prospective patient population
A total of 1,478 ERCPs were performed between April
2007 and April 2009, of which 951 ERCPs were performed
in patients referred from another hospital and therefore
were excluded. In total, we included 274 ERCPs (253
ERCPs were performed in patients who refused to partic-
ipate in follow-up), which were performed in 220 patients
(59% male, mean age = 60 ± 14 years), in the prospec-
tive study (Table 5). In 10% of the ERCP procedures
(27/274), post-ERCP complications developed during a
30 day follow-up, i.e., 14 episodes of pancreatitis (5%), 12
of cholangitis (5%), and 1 hemorrhage (0.1%). Pancreatitis
severity was mild after three, moderate after eight, and
severe after three ERCPs. Cholangitis severity was mild
after three and moderate after nine ERCPs. The case of
hemorrhage was graded as mild. None of the patients had
more than one complication.
Time to complication
Post-ERCP complications, i.e., pancreatitis and cholangitis,
occurred after a mean time of 4.1 h after ERCP, subdivided
in 4.2 h for pancreatitis and 4.1 h for cholangitis. Overall,
90% (23/26) of complications were detected within 6 h
after treatment. Complications occurring more than 6 h
after ERCP were cholangitis in 2 (after 7 and 16 h) and
pancreatitis in 1 (after 17 h) (Fig. 1).
Prognostic model
The prognostic model for post-ERCP pancreatitis and
cholangitis included eight risk factors. All these factors
were evaluated in the prospective patient series by multi-
variable logistic regression. Risk factors included (precut)
sphincterotomy (OR 1.6, CI 0.6–4.0), suspected SOD (not
defined), younger age (\60 years) (OR 1.0, CI 0.4–2.4),
PSC (OR 1.9, CI 0.5–8.0), female gender (OR 0.6, CI
0.2–1.5), history of pancreatitis (OR 1.4, CI 0.5–3.7),
pancreas divisum (OR 2.6, CI 0.2–30.5), and difficult
Table 2 Pooled odds ratios of predictors for overall post-ERCP complications from the literature review and odds ratios from univariable and
multivariable analyses of a retrospectively collected database
Predictors Literature reviewRetrospective population
Univariable analysisMultivariable analysis
Patient variables
Suspected SOD 2.6 (2.0–3.3)?
1.4 (1.2–1.5)?
NA
1.6 (0.9–2.2)?
NA
Female gender 1.3 (0.8–2.1)
History of pancreatitis
Younger age (\60 years)
Age (continuous)
NA0.9 (0.5–1.7)
1.3 (0.8–2.2)?
1.0 (1.0–1.02)?
0.4 (0.2–1.0)?
0.7 (0.4–1.5)?
NS
1.0 (1.0–1.1)1.7 (0.7–3.8)
NA1.0 (1.0–1.0)
Cholangitis at presentationNA0.5 (0.2–1.2)
Antibiotic use NA0.8 (0.4–1.6)
Cirrhosis NA1.3 (0.4–3.6)
1.8 (1.0–3.3)?
0.7 (0.4–1.2)?
NS
2.2 (1.1–4.4)?
PSCNA
Previous ERCP NA 0.9 (0.5–1.7)
Treatment variables
Therapeutic ERCPNA
1.7 (1.5–2.0)?
1.7 (0.8–3.8)?
1.9 (0.8–4.2)?
2.3 (1.4–3.9)?
1.5 (0.7–3.0)?
1.6 (0.9–2.7)?
1.4 (0.6–3.1)
Precut sphincterotomy1.6 (0.6–4.2)
2.2 (1.3–3.9)?
SphincterotomyNA
Balloon dilation CBDNA1.6 (0.8–3.3)
Difficult cannulation NA1.3 (0.7–2.4)
Values are odds ratio (confidence interval)
SOD sphincter of Oddi dysfunction, PSC primary sclerosing cholangitis, CBD common bile duct, NA not applicable, NS not significant
? P\0.5 in univariable analysis and P\0.05 in multivariable analysis
Surg Endosc (2011) 25:2892–29002895
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cannulation ([10 min attempting to cannulate) (OR 2.0, CI
0.7–5.6). The sum score for each of the risk factors was
derived from the coefficients of the regression analysis
from the review (Table 6). For example, a 58-year-old
female patient with PSC and undergoing an ERCP with
precut sphincterotomy has a sum score of 5 (1 ? 1 ?
2 ? 1).
Patients were scored as having a high risk (overall sum
score[3) or a low to intermediate risk (overall sum
score B 3). In the low- to intermediate-risk patient group,
complications occurred in 8% (20/252). In the high-risk
group, complications occurred in 27% (6/22) (Table 7).
Discussion
We present an overview of prognostic factors for (specific)
post-ERCP complications. Our prognostic model based on
these risk factors was able to distinguish between patients
at a high or a low risk of developing post-ERCP compli-
cations. This model may aid in the decision of whether
patients can be safely discharged at an early stage after
ERCP.
The data obtained from our systematic literature review
and the multivariable analysis of a large retrospective
population resulted in an accurate prediction model. This
model was based on a more or less complete overview of
all possible risk factors for post-ERCP pancreatitis and
cholangitis. Nevertheless, we recognize that using these
data may have some limitations. The risk factors in the
systematic review were derived from several studies and
therefore risk factors from heterogeneous patient groups
may have been included. For example, in some studies only
patients undergoing sphincterotomy or patients with SOD
were evaluated [4, 12, 19].
As expected, the results from the systematic review of
the literature and our retrospectively evaluated patient
population partially overlapped. Nevertheless, there were
some differences. For example, female gender was signif-
icant only in the univariable analysis of our population,
whereas it was a significant risk factor according to pooled
ORs [5, 14, 17, 19, 20]. Several studies have suggested that
Table 3 Pooled odds ratios of predictors for post-ERCP pancreatitis from the literature review and odds ratios from univariable and multi-
variable analyses of a retrospectively collected database
Predictors Literature reviewRetrospective population
Univariate analysis Multivariable analysis
Patient variables
Younger age (\60 years)
Age (continuous)
2.0 (1.6–2.5)?
4.0 (1.5–10.5)?
1.0 (1.0–1.1)?
1.8 (0.9–3.5)?
1.4 (0.6–3.2)?
3.4 (1.6–7.2)?
4.9 (1.2–19.6)?
NA
1.6 (1.3–1.8)?
1.9 (1.6–2.4)?
1.0 (1.0–1.0)
2.1 (1.0–4.6)?
Female gender
History of pancreatitis 1.8 (0.7–4.7)
4.6 (1.8–11.5)?
PSC NA
3.6 (2.3–5.3)?
Suspected SODNA NA
Small-diameter CBD1.5 NS
2.2 (1.4–3.4)?
NA
6.7 (0.8–57.5)?
0.2 (0.0–1.3)?
0.6 (0.3–1.2)?
NA
10.5 (1.0–112.8)?
Pancreas divisum
Cholangitis at presentationNA0.2 (0.03–1.6)
Previous ERCP NA0.6 (0.2–1.3)
Treatment variables
Precut sphincterotomy2.4 (1.8–3.2)?
1.6 (1.3–2.0)?
1.1 (0.3–4.7)1.3 (0.3–6.1)
Multiple PD contrast injectionsNA NA
Pancreatic sphincterotomy1.2 (0.9–1.4) NA NA
Therapeutic ERCP NA1.3 (0.5–3.7)
1.9 (0.9–4.1)?
NS
SphincterotomyNA1.5 (0.5–4.0)
Placement of endoprothese NA0.8 (0.4–1.7)
2.1 (0.9–5.2)?
2.0 (0.9–4.5)?
NS
Balloon dilation CBD NA2.2 (0.8–5.8)
Stone removal NA
2.5 (2.0–3.2)?
1.9 (0.7–4.9)
Difficult cannulation1.1 (0.5–2.6) NS
Values are odds ratio (confidence interval)
SOD sphincter of Oddi dysfunction, PSC primary sclerosing cholangitis, CBD common bile duct, NA not applicable, NS not significant, PD
pancreatic duct
? P\0.5 in univariable analysis and P\0.05 in multivariable analysis
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women are at a higher risk of post-ERCP complications,
which can be explained by the higher prevalence of SOD,
regardless of the clinical context or technical difficulty of
the ERCP [4, 10, 13]. The prevalence of (recognized) SOD
was low in our ERCP population and this may explain the
difference in the effect of gender with findings in the lit-
erature. For these reasons, we included female gender in
the prognostic model for post-ERCP complications.
Precut sphincterotomy has also been recognized as a risk
factor for post-ERCP complications. In published series
Table 4 Pooled odds ratios of predictors for post-ERCP cholangitis from the literature review and odds ratios from univariable and multi-
variable analyses of a retrospectively collected database
Predictors Literature reviewRetrospective population
Univariate analysisMultivariable analysis
Patient variables
Age (continuous)
Younger age (\60 years)
Female gender
NA1.0 (1.0–1.0)?
0.6 (0.3–1.3)?
0.7 (0.3–1.6)?
1.0 (1.0–1.0)
NA
2.8 (1.2–6.6)?
4.7 (1.9–11.7)?
4.8 (1.6–14.3)?
0.7 (0.2–2.5)
0.7 (0.3–1.6)
Small center NA
0.7 (0.3–1.8)?
1.6 (0.5–5.3)?
1.5 (0.6–3.8)?
2.3 (0.9–5.6)?
NA
Jaundice at presentation 0.6 (0.2–1.6)
Antibiotic use0.9 NS0.7 (0.3–2.2)
Previous ERCP NA1.4 (0.5–3.8)
Previous precut NA2.2 (0.9–5.8)
Treatment variables
Obstruction of CBD at end ERCP0.3 NSNA
2.8 (0.8–9.6)?
NA
3.9 (1.0–15.7)?
Placement expandable stentNA
Difficult cannulationNA1.2 (0.5–2.9)
2.1 (1.0–4.7)?
NS
2.8 (1.2–6.4)?
SphincterotomyNA
Precut sphincterotomy NA 1.2 (0.3–5.2)
1.3 (0.6–2.7)?
NS
Placement of endoprothesis3.1 (1.8–5.2)1.8 (0.8–3.9)
Values are odds ratio (confidence interval)
CBD common bile duct, NA not applicable, NS not significant in univariable analysis
? P\0.5 in univariable analysis and P\0.05 in multivariable analysis
Table 5 Characteristics of the ERCP procedure in a prospective
patient population
CharacteristicsNumber (%)
Number of procedures 274
Number of patients 220
Gender (% male)129 (59)
Age (±SD) 60 (±14)
Diagnostic procedures (%) 59 (22)
Virgin ERCPs (%) 77 (28)
Indication
CBD stones 62
Stenosis of the anastomosis after LTx 42
Malignant CBD obstruction 29
Chronic pancreatitis 28
PSC21
Acute pancreatitis11
PBC2
Other 79
Procedures
(Precut) sphincterotomy67
Placement of a plastic endoprothesis/stent 149
Balloon dilation of the CBD41
Removal of CBD stones 46
Ampullary resection7
CBD common bile duct, LTx liver transplant, PSC primary sclerosing
cholangitis
05
Time after ERCP (hours)
10 1520
0.0
0.1
0.9
1.0
Fraction complication
Fig. 1 Time between ERCP and complication
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this risk factor is suggested to be largely dependent on
experience of an endoscopist [3, 4, 17]. Nevertheless, we
were not able to establish precut sphincterotomy as a risk
factor in our series. This is likely to be due to the fact that
precut sphincterotomy was performed only by highly
experienced endoscopists in our center. Precut sphincter-
otomy in itself is often associated with a difficult cannu-
lation. As the latter was not a recorded risk factor for ERCP
complications inourretrospective
sphincterotomy might well be a substitute for this com-
plication, explaining the difference with literature findings.
Again, for these reasons, we included (precut) sphincter-
otomy as well as difficult cannulation in the prognostic
model for post-ERCP complications.
A history of post-ERCP pancreatitis has also been
reported to be a risk factor for post-ERCP pancreatitis
[1, 12, 14]. However, this was also not the case in our
population. We suspect that a history of pancreatitis is not a
database, precut
strong risk factor for recurrent pancreatitis, as it was found
to be significant only in univariable analysis in the litera-
ture review [1, 12, 14].
The multivariable analysis of risk factors in our retro-
spective population established some factors that were not
previously evaluated in the literature. For example, we
found that the presence of PSC was a risk factor for post-
ERCP pancreatitis. Previous studies have suggested that
this is a risk factor for post-ERCP complications due to the
often difficult and multiple cannulation attempts in PSC
patients, particularly in the presence of complicated stric-
tures [25, 26]. In addition, we also found that younger age
was a risk factor for pancreatitis. Freeman et al. [13] have
suggested that younger age as a risk factor was in fact
caused by the fact that authors did not correct for con-
founding variables. An explanation for younger age as risk
factor may also be the progressive decline in pancreatic
exocrine function that occurs with aging, which may pro-
tect older patients from developing pancreatitis as a con-
sequence of ERCP.
We excluded all patients who were referred from other
hospitals, and investigated only patients who were pri-
marily admitted to our university hospital. The latter group
is likely to have more comorbidity compared to patients
treated in regional hospitals, which could have influenced
our results.
Our prognostic model was able to distinguish patients
with a low to intermediate risk from those with a high
risk for post-ERCP pancreatitis or cholangitis, resulting in
8% of all patients being at high risk. These results are
comparable to the results of the prognostic model devel-
oped by Friedland et al. [14], who found that 7% of all
patients undergoing ERCP were at a high risk for post-
ERCP pancreatitis. Friedland et al. [14] were the first to
propose a simple prognostic model for post-ERCP pan-
creatitis composed of the risk factors of pain during the
procedure, cannulation of the pancreatic duct, history of
pancreatitis, and difficult cannulation. Their model was
based on a multivariable analysis of retrospectively col-
lected data and therefore missed various risk factors
known from other studies, i.e., SOD, gender, and precut
sphincterotomy. In addition, the model was validated
using the same database that was used to determine the
risk factors for the prognostic model. Evaluation of a
prognostic model in another population is preferable. This
should enable one to determine whether the model is
indeed generally applicable.
Besides the limitations from the systematic review and
the retrospective patient population, our prognostic model
has additional limitations. When we compared the selected
risk factors in our prospective patient population with the
pooled ORs from the systematic review, we found differ-
ences in the level of significance, probably a result of the
Table 6 Combined scores for a prognostic model of pancreatitis and
cholangitis and ORs from the literature and a multivariable analysis of
a retrospective (n = 1372) and prospective (n = 255) patient
population
CharacteristicsScore
(Precut) sphincterotomy?1
SOD
Younger age (\60)
PSC
?1
?1
?2
Female gender?1
History of pancreatitis?1
Pancreas divisum
Difficult cannulationa
?1
?1
SOD sphincter of Oddi dysfunction, PSC primary sclerosing
cholangitis
aDefined as more than 10 min of attempting to cannulate
Table 7 Post-ERCP pancreatitis or cholangitis by score
Score ERCPs without
cholangitis or
pancreatitis
ERCPs with
cholangitis or
pancreatitis (%)
Risk groups
0 383 (7) Low- to intermediate-risk
group:
1 84 11 (12) 252 patients (92% of total)
2 705 (6)8% risk
3 401 (7)
4 15 5 (25)High-risk group:
5?11 (50)22 patients (8% of total)
27% risk
2898 Surg Endosc (2011) 25:2892–2900
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Page 8

relatively small study population. Nonetheless, the mag-
nitude of the ORs of the risk factors was comparable.
A few studies have suggested that size of a center and
experience of an endoscopist both have an effect on the risk
of post-ERCP complications. Therefore, our model can be
used only in patients undergoing ERCP in a center in which
endoscopists perform more than 150 ERCPs per year and
also an otherwise experienced team is present [17]. This is
illustrated by the findings of Loperfido et al. [17] who
reported an increased risk of developing post-ERCP com-
plications in a small center compared to a large center.
According to their study, one could correct for this by
adding an additional score of 1 to the model in case an
ERCP is performed in a small-volume center and/or by a
less experienced team. This needs to be investigated in
future studies.
In conclusion, our results show that the prognostic
model that we developed is able to identify patients with a
high risk of developing pancreatitis or cholangitis after
ERCP (Fig. 2). On the other hand, it also identifies patients
at low to intermediate risk who can safely be discharged
6 h after ERCP. In addition, we also suggest that patients
be admitted overnight when the ERCP is associated with an
increased risk of perforation and hemorrhage.
Disclosure
J. Dees, J. W. Poley, J. Haringsma, and E. J. Kuipers have no conflicts
of interest or financial ties to disclose.
S. M. Jeurnink, P. D. Siersema, E. W. Steyerberg,
Open Access
Creative Commons Attribution Noncommercial License which per-
mits any noncommercial use, distribution, and reproduction in any
medium, provided the original author(s) and source are credited.
This article is distributed under the terms of the
Overnight observation
(observation 24 hours)
NO
NO
High risk procedure
- (precut) sphincterotomy in patients
with a coagulation disorder
- First time balloon dilation
-Papillectomy
Hemorrhage during ERCP
or free air on X-ray
Score >3 in the prognostic
model
Eligible for early discharge
6 hours after ERCP
NO
YES
YES
YES
Complications within 6
hours after ERCP
YES
NO
Fig. 2 Proposal of a decision
model for early discharge after
ERCP
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