Post-ERCP Pancreatitis

Martin L Freeman
Division of Gastroenterology, University of Minnesota, Hennepin County Medical Center.
Minneapolis, MN, USA
Introduction
Reported rates of pancreatitis after ERCP and
sphincterotomy range from less than one
percent to 40 percent, but rates of 5 percent or
more are typical [1, 2, 3, 4, 5, 6, 7, 8, 9,10, 11,
12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23].
Variations in reported rates of pancreatitis
relate to many factors including the definition
used, the thoroughness of follow up [24], and
to patient and technique-related risk factors.
In the consensus classification [1],
pancreatitis is defined as clinical syndrome
consistent with pancreatitis (i.e. new or
worsened abdominal pain) with an amylase at
least three times normal at more than 24 hours
after the procedure, and requiring more than
one night of hospitalization (Table 1). Some
events are difficult to classify in the
consensus definition, such as for patients with
post-procedural abdominal pain and elevation
of amylase to just under 3 times normal, or
those with dramatic amylase elevations but
minimal symptoms that are not clearly
suggestive of clinical pancreatitis. 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 is not
known, recent studies have used multivariate
analyses to identify the clinical patient and
procedure-related
factors
that
are
independently associated with pancreatitis [3,
16, 18, 19, 20, 21, 22]. However, even
multivariate analyses can sometimes be
misleading if key variables are not assessed,
thereby making surrogate associated markers
appear significant instead [25].
Patient-Related Risk Factors for Post-
ERCP Pancreatitis
Risk of post-ERCP pancreatitis is determined
at least as much by the characteristics of the
patient as by endoscopic techniques or
maneuvers (Table 2). Patient-related
predictors found to be significant in one or
more major studies include younger age,
indication of suspected sphincter of Oddi
dysfunction, history of previous post-ERCP
pancreatitis, and absence of elevated serum
bilirubin [3, 16, 18, 19, 20, 21, 22]. Women
Table 1. Consensus definitions for the major complications of ERCP [1].
Mild pancreatitis
Clinical pancreatitis, amylase at least three times normal at more that 24 h after the
procedure, requiring admission or prolongation of planned admission to 2-3 days
Moderate pancreatitis
Pancreatitis requiring hospitalization of 4-10 days
Severe pancreatitis
Hospitalization for more than 10 days, pseudocyst, or intervention (percutaneous drainage
or surgery)
Any intensive care unit admission after a procedure grades the complication as severe

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may have increased risk [18], but it is difficult
to sort out the contribution of sphincter of
Oddi dysfunction, a condition that almost
exclusively occurs in women. Patients with
multiple risk factors have dramatically
enhanced risk [18, 21].
Sphincter of Oddi dysfunction, most often
suspected in women with post-
cholecystectomy abdominal pain [26, 27, 28],
poses a formidable risk for pancreatitis after
any kind of ERCP whether diagnostic,
manometric or therapeutic [4, 5, 6, 7, 14, 16,
18]. Suspicion of sphincter of Oddi
dysfunction independently increases the risk
of post-ERCP pancreatitis by as much as five-
fold to about 10-30% (Figure 1). The reason
for heightened susceptibility in these patients
remains unknown. Contrary to the widely
held opinion that sphincter of Oddi
manometry is the culprit [29, 30], recent
multivariate analyses have shown that
empirical biliary sphincterotomy or even
diagnostic ERCP has a similarly high risk [16,
18, 31]. In a large multicenter study, biliary
sphincterotomy after manometry was
associated with an 18% risk of pancreatitis,
but empirical biliary manometry was
associated with a similarly high pancreatitis
rate of 20% [16]. With the widespread use of
aspirating instead of conventional perfusion
catheters, the risk of manometry has probably
been reduced to that of cannulation with any
other ERCP accessory [31]. The perception
that manometry is high risk results in the past
from use of perfusion catheters in the
pancreatic duct, and more recently from the
fact that in centers where it is performed,
manometry is always performed in patients
with suspected sphincter of Oddi dysfunction,
thus losing the ability to separate the
contribution of risk from the procedure from
that of the patient. Absence of a stone in
patients with suspected choledocholithiasis
was found to be the most potent single risk
factor for post-ERCP pancreatitis in a prior
study in which the diagnosis of sphincter of
Oddi dysfunction was not considered [21].
These observations point out the danger of
performing diagnostic ERCP to look for bile
duct stones in women with recurrent post-
cholecystectomy pain and minor or no liver
chemistry abnormalities, as there is generally
a low probability of finding stones in such
Figure 1. Frequency of complications of 2,347 biliary
sphincterotomies by indication [16].
Table 2. Risk factors for post-ERCP pancreatitis in multivariate analyses.
Definite *
Maybe **
No ***
Suspected sphincter of Oddi dysfunction Female sex
Small CBD diameter
Young age
Acinarization
Sphincter of Oddi manometry
Normal bilirubin
Absence of CBD stone
Biliary sphincterotomy
History of post-ERCP pancreatitis
Lower ERCP case volume
Difficult cannulation
Pancreatic duct contrast injection
Pancreatic sphincterotomy
Precut sphincterotomy
Balloon dilation of biliary sphincter
* Significant by multivariate analysis in most studies
** Significant by univariate analysis only in most studies
*** Not significant by multivariate analysis in any study
CBD: common bile duct

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171
patients, and a high risk of causing
pancreatitis. It is an erroneous and potentially
dangerous assumption that merely avoiding
sphincter of Oddi manometry will
significantly reduce risk.
History of previous post-ERCP pancreatitis
was found to be a potent risk factor (OR 5.4)
in the only study to evaluate it [18], and
warrants special caution. Advanced chronic
pancreatitis, on the other hand, confers some
immunity against ERCP-pancreatitis, perhaps
because of atrophy and decreased enzymatic
activity [18]. Pancreas divisum is only a risk
factor if minor papilla cannulation is
attempted [18].
Technique-Related Risk Factors for post-
ERCP Pancreatitis
Technical factors have long been recognized
to be important in causing post-ERCP
pancreatitis. Papillary trauma induced by
difficult cannulation has a negative effect that
is independent of the number of pancreatic
duct contrast injections [16, 18]. Pancreatitis
occurred in one study after 2.5% of ERCP in
which there was no pancreatic duct contrast
injection at all [18]. Pancreatic contrast
injection itself is independently associated
with pancreatitis risk, and increases with
number of injections [16, 18]. Acinarization
of the pancreas, although undesirable, is
probably less important than generally
thought [3, 16, 18, 20].
Overall, risk of pancreatitis is generally
similar for diagnostic and therapeutic ERCP
[4, 18, 20] (Figure 2). Performance of biliary
sphincterotomy does not appear to add
significant independent risk of pancreatitis to
ERCP [18, 20], a finding that is contrary to
widely held opinion [1]. This points not to the
safety of sphincterotomy, but rather to the risk
of
diagnostic
ERCP.
Pancreatic
sphincterotomy was found to be a significant
risk factor for pancreatitis in the only large
multivariate study in which it was evaluated
[18], although the risk of severe pancreatitis
was very small (less than one percent),
perhaps because nearly all of these patients
had pancreatic drainage via a pancreatic stent.
Precut, or access papillotomy to gain access
to the common bile duct has uniformly been
associated with a higher risk of pancreatitis in
multicenter studies involving endoscopists
with varied experience [3, 16, 18, 20]. This
elevated risk emerges even after adjusting for
difficulty of cannulation [3, 15, 16, 18, 20,
23]. In contrast, many series from tertiary
referral centers have found complication rates
no different than for standard sphincterotomy
[32, 33, 34, 35, 36, 37, 38, 39, 40, 41],
suggesting that risk of precut sphincterotomy
is highly operator-dependent. However, a
single expert endoscopist reported that with
increasing experience, although his success
rate improved, the complication rate remained
quite high at nearly 15%; this author did not
use pancreatic stents [42]. Use of pancreatic
stents prior to needle-knife precut [41],
different technique, or different case mix may
account in part for lower rates of precut-
induced pancreatitis by other advanced
endoscopists. Complications of precut
sphincterotomy probably vary with the
indication for the procedure (most risky with
sphincter of Oddi dysfunction in the absence
of pancreatic stenting) [16] and probably with
other anatomic factors such as small papillas.
Balloon-dilation of the biliary sphincter has
been introduced as an alternative to
sphincterotomy for the extraction of bile duct
stones [43, 44]. Although two randomized
trials from overseas have shown
complications to be equivalent to or less than
for sphincterotomy [45, 46], balloon dilation
has been associated with a markedly
Figure 2. Post-ERCP pancreatitis for diagnostic versus
therapeutic ERCP [18].

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172
increased in risk of pancreatitis in the U.S.,
resulting in two deaths in one study [18, 47].
It is not clear why results of balloon dilation
are so different between the United States and
other regions of the world. In general, we do
not recommend balloon dilation for extraction
of bile duct stones unless there is a relative
contraindication to sphincterotomy such as
coagulopathy or need for early
anticoagulation. Balloon dilation should
especially be avoided in higher-risk patients
such as younger patients who are anicteric –
the very patients in whom one might
otherwise be most interested in sphincter
preservation.
Use of a papillotome for biliary cannulation
has been prospectively compared to a
standard catheter in two randomized trials
[48, 49]. Although both showed significantly
higher success with the sphincterotome, there
was no difference in rates of pancreatitis or
other complications. It stands to reason,
however, that the most expeditious method of
cannulation will likely be the safest.
Thermal injury is thought to play some role in
causing
pancreatitis
after
biliary
sphincterotomy. Two studies have evaluated
different current generators for electrocautery
[50, 51]. Bipolar cautery, which is seldom
used, was shown in one study to result in
significantly lower rates of pancreatitis than
conventional monopolar cautery (0 vs. 6 %)
[50]. A more recent study showed that pure
cutting current significantly reduced
pancreatitis rates when compared with the
more conventional blended current (3% vs.
11%) [51]. Automated current delivery
systems such as ERBE (Surgical Technology
Group, Hampshire, England, UK) are
increasingly used, but their effect on
pancreatitis is unclear. Preliminary data
suggest no difference in pancreatitis rates
compared with conventional blended current
[52].
Most multicenter studies have failed to show
a significant correlation between ERCP case
volumes and pancreatitis rates [13, 16, 18]. In
one study, endoscopists averaging more than
100 ERCP per year did not have significantly
lower pancreatitis rates, but did have
substantially higher rates of success at bile
duct access (96.5% versus 91.5% for lower
volume endoscopists) [18]. It is possible that
none of the participating endoscopists in those
studies reached the threshold volume of
ERCP above which pancreatitis rates would
diminish (perhaps greater than 250-500 cases
per year). However, most American
endoscopists average less than 2 ERCPs per
week [18], and the reported rates of
pancreatitis from the highest volume tertiary
referral centers in the U.S. are often relatively
higher than those in private practices [16, 18].
All of these observations suggest that case
mix is at least as important as expertise in
determining risk of post-ERCP pancreatitis.
Pancreatic Stenting to Reduce Risk of Post-
ERCP Pancreatitis
Pancreatic stent placement can reduce risk of
post-ERCP pancreatitis in a number of
settings (Table 3), and is widely performed at
many advanced centers for this purpose
(Figure 3). Specific situations where
placement of a pancreatic stent has been
shown to reduce risk include after biliary
sphincterotomy for sphincter of Oddi
dysfunction (Figure 3) [53], after pancreatic
sphincterotomy [54], prior to precut
sphincterotomy (Figure 3) [41] and after
balloon-dilation of the biliary sphincter [55].
A randomized trial suggested equivocal
benefit of pancreatic stenting for difficult
Table 3. Pancreatic stents to reduce risk of post-ERCP
pancreatitis.
Setting
Benefit Evidence
Biliary sphincterotomy for
SOD
Yes
RCT
Pancreatic sphincterotomy for
SOD
Yes
RCT
(abstract)
Biliary balloon dilation for
stone
Yes
RCT
Precut (access) biliary
sphincterotomy
Yes
RCT
(abstract)
“High risk” including difficult
cannulation
Equivocal
RCT
SOD: sphincter of Oddi dysfunction
RCT: randomized controlled trial

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173
cannulation and other high-risk situations;
however, the stents were placed relatively late
in the procedure, perhaps after the damage
was done. There was elimination of severe
pancreatitis, however, in the group receiving
pancreatic stents [56]. Liberal use of
pancreatic stents for high-risk procedures at
advanced centers has resulted in substantially
reduced rates of pancreatitis, and with virtual
elimination of any pancreatitis for routine
obstructive biliary disease, and of severe
pancreatitis for the highest risk cases [18, 41,
56]. One large study showed that in patients
with sphincter of Oddi dysfunction, combined
pancreatic and biliary therapy including a
pancreatic stent was significantly safer than
conventional biliary sphincterotomy alone
[57].
After
conventional
biliary
sphincterotomy, pancreatitis occurred in 26%,
and 5% were severe, rates consistent with
other prospective studies. In contrast, the rate
of pancreatitis after combined pancreatic and
biliary therapy including a pancreatic stent
was under 15% with no episodes of severe
pancreatitis in over 100 cases. It is difficult
for many endoscopists who do not utilize
pancreatic stents on a regular basis to accept
the concept that invasive manipulation of the
pancreas with a stent and even pancreatic
sphincterotomy may be safer than ERCP that
is diagnostic or involves primarily biliary
instrumentation.
For prevention of pancreatitis, we recommend
placement of small caliber (3 to 5 French)
stents relatively early in the procedure in all
high risk circumstances for which stents have
proven effective as listed above, and also for
difficult cannulation in patients who are
younger, female, and have a normal pancreas.
In this setting we generally use short (2-3 cm)
flanged stents as premature dislodgement and
resultant delayed pancreatitis is problematic
with short unflanged stents. Some centers are
using very long (8 cm or longer) small caliber
(3-4 French) unflanged stents, and allowing
them to pass spontaneously within a few
weeks. Placement of pancreatic stents is
usually unnecessary regardless of cannulation
difficulty in older, jaundiced patients
especially if they have a pancreatic duct
obstructed by cancer.
Pancreatic stenting has limitations as a
strategy to reduce risk. Many endoscopists
and their assistants are unfamiliar with their
placement and may have a substantial failure
rate, leaving the patient worse off than if no
attempt was made. Once placed, pancreatic
stents have potential to cause ductal injury or
perforation, especially if placed in a normal
duct, or if the size or shape are mismatched to
the duct [58, 59]. Whatever stent is used, it
should be documented to have passed by pain
abdominal X-ray or be removed via
endoscopy within two weeks of placement in
a normal duct.
Cumulative Effect of Multiple Risk Factors
on Post-ERCP Pancreatitis
Risk of post-ERCP pancreatitis escalates in
patients with multiple risk factors [40]. For
the same difficulty of cannulation, one
multivariate analysis showed that addition of
normal serum bilirubin, female gender, and
possible sphincter dysfunction increased the
risk of pancreatitis by more than 10-fold [18].
The interactive effect of multiple risk factors
is reflected in the profile of patients
developing severe post-ERCP pancreatitis. In
two different studies, nearly all of the patients
Figure 3. Post-ERCP pancreatitis: results of
randomized controlled trial of pancreatic stenting to
reduce risk of biliary sphincterotomy in patients with
sphincter of Oddi dysfunction [53]. Eighty patients
with pancreatic sphincter hypertension undergoing
endoscopic biliary sphincterotomy randomized to
short-term pancreatic stent versus no stent after
sphincterotomy.

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174
who developed severe or fatal pancreatitis
were young to middle-aged women with
recurrent abdominal pain, a normal serum
bilirubin, and with no biliary obstructive
pathology - therefore consistent with the
syndrome of possible sphincter of Oddi
dysfunction, whether or not it was suspected
by the endoscopist [18, 60]. Nearly half were
purely diagnostic procedures. Some involved
relatively easy cannulation. None involved
placement of a pancreatic stent in the major
papilla. Few if any of these patients had much
probability of harboring obstructive biliary
pathology or of benefiting from conventional
therapeutic ERCP such as empirical biliary
sphincterotomy.
Keywords
Acute
Disease;
Cholangiopancreatography,
Endoscopic
Retrograde;
Pancreatitis/complications;
Sphincterotomy, Endoscopic
Correspondence
Martin L Freeman
University of Minnesota
Division of Gastroenterology
Hennepin County Medical Center
701 Park Avenue South
Minneapolis, MN 55415
USA
Phone: +1-612.347.8582
Fax: +1-612.904.4366
E-mail address: freem020@tc.umn.edu
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