Scandinavian Journal of Gastroenterology

ISSN: 0036-5521 (Print) 1502-7708 (Online) Journal homepage: http://www.tandfonline.com/loi/igas20

New classification system for indications for

endoscopic retrograde cholangiopancreatography
predicts diagnoses and adverse events

Nicholas Yuen, Pauline OShaughnessy & Andrew Thomson

To cite this article: Nicholas Yuen, Pauline OShaughnessy & Andrew Thomson (2017): New
classification system for indications for endoscopic retrograde cholangiopancreatography
predicts diagnoses and adverse events, Scandinavian Journal of Gastroenterology, DOI:
10.1080/00365521.2017.1384053

To link to this article: http://dx.doi.org/10.1080/00365521.2017.1384053

Published online: 28 Sep 2017.

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 SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY, 2017
https://doi.org/10.1080/00365521.2017.1384053

ORIGINAL ARTICLE

New classification system for indications for endoscopic retrograde

cholangiopancreatography predicts diagnoses and adverse events
Nicholas Yuena, Pauline OShaughnessyb and Andrew Thomsona,c
a
Australian National University Medical School, Acton, Australia; bStatistical Consulting Unit, Australian National University, Acton, Australia;
c
Gastroenterology Unit, The Canberra Hospital, Canberra, Australia

ABSTRACT ARTICLE HISTORY

Background: Indications for endoscopic retrograde cholangiopancreatography (ERCP) have received lit- Received 7 August 2017
tle attention, especially in scientific or objective terms. Revised 9 September 2017
Aim: To review the prevailing ERCP indications in the literature, and to propose and evaluate a new Accepted 15 September 2017
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ERCP indication system, which relies on more objective pre-procedure parameters.

Methods: An analysis was conducted on 1758 consecutive ERCP procedures, in which contemporan- KEYWORDS
eous use was made of an a-priori indication system. Indications were based on the objective pre-pro- Cholangiopancreatography;
cedure parameters and divided into primary [cholangitis, clinical evidence of biliary leak, acute (biliary) endoscopic retrograde;
pancreatitis, abnormal intraoperative cholangiogram (IOC), or change/removal of stent for benign/ biliary tract diseases;
malignant disease] and secondary [combination of two or three of: pain attributable to biliary disease choledocholithiasis
(P), imaging evidence of biliary disease (I), and abnormal liver function tests (LFTs) (L)]. A secondary
indication was only used if a primary indication was not present. The relationship between this newly
developed classification system and ERCP findings and adverse events was examined.
Results: The indications of cholangitis and positive IOC were predictive of choledocholithiasis at ERCP
(101/154 and 74/141 procedures, respectively). With respect to secondary indications, only if all three
of P, I, and L were present there was a statistically significant association with choledocholithiasis
(v2(1) 35.3, p < .001). Adverse events were associated with an unusual indication leading to greater
risk of unplanned hospitalization (v2(1) 17.0, p < .001).
Conclusions: An a-priori-based indication system for ERCP, which relies on pre-ERCP objective parame-
ters, provides a more useful and scientific classification system than is available currently.

Introduction indications were thus examined and evaluated by searching

the literature.
On a per-procedure basis, endoscopic retrograde cholangio-
A new a-priori system for ERCP indications, that is, a set of
pancreatography (ERCP) is far and away the most risky of the
indications that are able to be defined by available pre-pro-
commonly performed endoscopic procedures, in which the
cedure data, has been developed and was evaluated to
skin is not breached [1]. Ensuring that each and every pro-
determine if the classification of ERCP indications can be
cedure is indicated is, therefore, important. It is thus surpris-
made more objective and thereby potentially enable
ing that there has been so little attention paid to developing
improved practice in this area. In addition, how predictive
a systematic, objective approach to the classification of ERCP
the new classification system is in terms of ERCP findings
indications. Current ERCP guidelines enunciate the import-
and adverse events was also assessed.
ance of careful selection of cases for ERCP and provide lists
of recommended indications for this procedure [2,3].
However, there is still reliance on subjective parameters such
as jaundiced patient suspected to have a biliary obstruction Methods
and general overarching concepts such as clinical and bio-
Literature review
chemical or imaging data suggestive of pancreatic or biliary
tract disease [2]. In addition, many indications in unselected Case series of ERCPs were reviewed to ascertain the current
series of consecutive ERCP procedures suffer from presuppos- indication criteria used for ERCP. The search criteria used
ing a diagnosis suspected choledocholithiasis. This lack of were as follows:
a systematic and objective approach to the classification of
ERCP indications represents a gap in which progress may be  greater than 500 ERCP cases,
made in terms of potentially reducing unnecessary ERCP pro-  consecutive, unselected cases,
cedures. The currently used classification systems for ERCP  ERCP carried out in humans,

CONTACT Nicholas Yuen u5513193@anu.edu.au Australian National University Medical School, Florey Building, 54 Mills Road, Acton ACT 2601, Australia
2017 Informa UK Limited, trading as Taylor & Francis Group
 2 N. YUEN ET AL.

Publicaons idened
through database
search (n=1396)

Excluded aer
screening
tle/abstract (n=1360)

Full text arcles

assessed for eligibility
(n=36)

Excluded aer full text

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analysis (n=29)

Publicaons from
database search
included in study
(n= 7)

Publicaons sourced
from bibliographies
and others (n=5)

Total publicaons
included in study
(n=12)

Figure 1. Literature review flow chart.

 literature published in English, and that did not comprise more than 2% of indications in any
 published in the last 10 years (2004 onwards). single study have been excluded for simplicity.

The literature search was conducted using the

PubMed database, using the MeSH, and search terms
cholangiopancreatography, endoscopic retrograde, and
ERCP. The search was refined by the types of publications
classified as Clinical Trial, Comparative Study, and Research
Support. In addition to publications sourced from this
PubMed search, publications were also sourced from the bib-
liographies of the papers that underwent full text analysis.
Figure 1 shows the flow chart of the literature review
method.
With regard to analysis of the ERCP indications identified
from the literature review, these were grouped into broad
classifications in order to reveal any patterns in the nature of
the indications used. The following categories were used to
group the indications: clinical observation, imaging abnor-
malities, objective laboratory data, procedural intention, and
suspected or apparent diagnosis. Those specific indications
New a-priori system for ERCP indications and its
evaluation
A database containing details of 1758 consecutive ERCP pro-
cedures conducted at the Canberra Hospital by a single
expert operator (the ERCP database) between 26 February
2008 and 22 December 2014 was developed and subse-
quently analyzed to investigate the appropriateness of a set
of ERCP indications that were based on a-priori objective
parameters. Data were contemporaneously collected and
recorded by the ERCP operator and included parameters
such as patient demographic data, indication, finding, pres-
ence of previous sphincterotomy, whether the desired duct
was deeply cannulated, whether a pancreatic stent was
placed, the development of post-ERCP pancreatitis, and the
occurrence of unplanned hospital admission/prolongation of
 SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY 3

Table 1. Frequency table of the ERCP indications.

ERCP indication N (%) (total N 1758)
Primarya Cholangitis: febrile illness with jaundice for which no other clinical 154 (8.8)
cause was evident, with or without abdominal pain.
Biliary leak: significant leakage of biliary fluid through a surgical 44 (2.5)
drain following biliary surgery (including gall bladder surgery)
usually associated with abdominal pain, but not always.
Acute (biliary) pancreatitis: epigastric pain with lipase levels greater than 5 times the 193 (11.0)
upper limit of normal with associated rise in liver function tests (LFTs) or
imaging evidence of choledocholithiasis.
Intraoperative cholangiogram (IOC): imaging evidence of a bile duct stone seen 141 (8.0)
on intraoperative cholangiogram performed during cholecystectomy.
Change or removal of biliary stent for malignant disease (C/ROSM). 60 (3.4)
Change or removal of biliary stent for benign disease (C/ROSB). 284 (16.2)
Secondaryb Combination clinical findings: Combination of at least 2 of 3 of the following:
1. Pain (P): defined as epigastric or PIL 475 (27.0)
right upper quadrant pain.
2. Abnormal imaging (I): defined PI 53 (3.0)
as imaging to suggest significant
abnormalities of the bile duct.
3. LFT abnormalities (L): defined as PL 128 (7.3)
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significant abnormalities in LFTs.

IL 179 (10.2)
Other: ERCP conducted for any other reason. 47 (2.7)
a
Primary indications are listed in order of priority allocation to a higher priority indication precluded an indication lower down
being used, and it was only possible for a patient to have one primary indication.
b
A secondary indication was only used if a patient did not have a primary indication.

hospital stay following ERCP. The ERCP indication categories
used are listed and defined in Table 1.
Primary indications
There were six primary indication categories such as cholan-
gitis, biliary leak, acute (biliary) pancreatitis, positive intrao-
perative cholangiogram (IOC), change/removal of stent for
malignant disease, and change/removal of stent for benign
disease. The indications were prioritized in that if there were
more than one, then the one higher on the list (as specified
in Table 1) was used. For instance, if a patient presented
with both cholangitis and pancreatitis, then cholangitis was
used as the indication. Similarly, if a patient who had previ-
ously undergone biliary stenting for a malignant stricture,
presented with cholangitis secondary to blockage of the
stent, then this was classified as cholangitis. If and only if a
patient did not fall into one of these six categories, an appro-
priate secondary indication was invoked. In addition, if an
indication was itself a diagnosis, clearly defined parameters,
which were as objective as possible were used.
Secondary indications
Secondary indications, which were only used if a primary
indication was not applicable, consisted of a combination of
two or three of: epigastric or right upper quadrant pain (P),
imaging suggestive of significant abnormalities of the bile
duct (I), and significant abnormalities in LFTs (L). No precise
numeric criteria were used in determining if abnormal LFTs
were considered significant, but in general there had to be
either a sharp, recent increase over a day or two in more
than one biochemical marker (alanine transaminase, bilirubin,
and gamma-glutamyl transferase) or a persistent level of ele-
vation in at least two of these markers, one of which was bili-
rubin. Care was taken to ensure as far as possible that
alternative causes of elevated LFTs/bilirubin were excluded
such as parenchymal liver disease or Gilberts syndrome. A
small group of patients did not fall into any of the primary
or secondary indications and were grouped together under
the indication of other.
The findings at ERCP were classified into seven categories.
These are summarized in Table 2. Findings classified as N/A
indicate that no cholangiogram was conducted, commonly
due to lack of biliary access or when a cholangiogram was not
necessary. Post-ERCP, patients were followed proactively with
telephone calls by the endoscopist both on the evening of the
procedure and the next day. If the patient was an inpatient,
either the endoscopist reviewed the patients in person or tele-
phoned the nursing staff supervising the patients both on the
evening of the ERCP and the following day. In our hospital,
most patients undergo ERCPs as outpatients. Inpatient ERCPs
were almost all performed on patients whose clinical status
mandated inpatient care. ERCP-related adverse events includ-
ing the occurrence of either post-ERCP pancreatitis or other
instances of unplanned hospital admission/prolongation of
hospital stay were documented contemporaneously.
Statistical analysis was conducted on the ERCP data using
the IBM SPSS Statistics 22.0 program (Armonk, NY). To inves-
tigate the association between ERCP indications, findings and
occurrence of adverse events, separate chi-squared tests
were performed for every combination of these variables.
The Fishers exact test was used in cases where total sample
size was small and the expected count in contingency table
cells was less than 5. Results were assessed as statistically sig-
nificant if p values were smaller than .05.
Results
Literature review
Twelve papers meeting the above criteria were identified,
covering a date range from 2004 to 2014, and a total of
 4 N. YUEN ET AL.

Table 2. Frequency table of the ERCP outcomes in the ERCP database.

ERCP findings N (%) (total N 1758)
Pathological finding Stone: bile duct filling defect consistent with a stone. 636 (36.2)
Stricture: bile duct stricture. 332 (18.9)
Dilated duct: diffusely dilated bile duct without evidence of a stricture or stone. 167 (9.5)
Bile leak. 25 (1.4)
Other. 35 (2.0)
N/A No cholangiogram performed. 170 (9.7)
Normal No abnormalities found on cholangiogram. 393 (22.4)

Table 3. Summary of literature that passed search criteria.

Author Year Type of study No. of cases Top 5 indications for ERCP (%)
Balik et al. [4] 2013 Retrospective 5884 Jaundice (48.3)
Abdominal pain (37.5)
Cholangitis (6)
Biliary fistula (5.3)
Follow-up (2.1)
Christensen et al. [5] 2004 Prospective 1177 Elevated liver test with jaundice (32.3)
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Elevated liver test without jaundice (20.9)

Colton et al. [7]
Cote et al. [18]
Cotton et al. [19]
Ekkelenkamp et al. [20]
Katsinelos et al. [21]
Siiki et al. [22]
Suissa et al. [23]
Testoni et al. [24]
Vitte and Morfoisse [25]
Williams et al. [26]
Suspected bile duct stone at ultrasound (US), MR, or cholangiography
(32.8)
Biliary pancreatitis (8.4)
Chronic pancreatitis (8.2)
2009 Prospective 805 Choledocholithiasis (31.2)
Clinical and biochemical or imaging data suggestive of pancreatic or
biliary tract disease (25.2)
Suspected stone (24.6)
Jaundice thought secondary to biliary obstruction (16.4)
Stent placement across strictures, fistulae, postoperative bile leak, or
large common bile duct stones (7.2)
2013 Retrospective 16,968 Abdominal symptoms (37.2)
Gallstone disease (33.1)
Other bile duct/liver pathology (22.4)
Bile duct obstruction (19.6)
Abnormal laboratory parameters (18.5)
2009 Retrospective 11,497 Biliary stent insertion or extraction (34.1)
Pancreatitis (historical) (25.9)
Suspected SOD (25.4)
Jaundice (21.3)
Suspected or known stone (16.1)
2014 Prospective 1515 Suspicion of common bile duct (CBD) stones (22.8)
Malignant stenosis (23.7)
Benign stenosis (18.0)
Chronic pancreatitis (12.5)
Primary sclerosing cholangitis (5.9)
2014 Retrospective 2715 Choledocholithiasis (76.3)
Biliary cancer (9.3)
History of pancreatitis (3.2)
Bile duct leak (2.5)
SOD (2.9)
2012 Retrospective 1207 CBD stone (32.2)
Malignancy (20.9)
Bile duct obstruction or jaundice without accurate diagnosis (20.8)
Acute biliary pancreatitis (7.8)
Acute cholangitis (7.2)
2004 Prospective 722 Suspected CBD stone (58)
Suspected tumor of the pancreas/bile duct (30)
Post cholecystectomy complications (leak/stenosis) (6)
Treatment of chronic pancreatitis (1)
Diagnostic (5)
2010 Prospective 3635 Choledocholithiasis (45.5)
Known or suspected malignant biliary stricture (19.7)
Cholangitis (6.5)
Suspected SOD (4.3)
Chronic pancreatitis (3.7)
2007 Prospective 2708 Lithiasis of the CBD (62.5)
Stenosis by tumor (22.5)
Revision after ERCP with endoscopic sphincterotomy (18.3)
Postoperative biliary complications (3.3)
2007 Prospective 4561 Ductal stones (w/o coexisting pancreatitis or cholangitis) (54.3)
Malignancy, including jaundice with dilated duct w/o evidence of
stones (19.5)
Pancreatitis (acute and chronic) (9.5)
Cholangitis (5.4)
Biliary leak (2.2)

Table 4. Frequency of ERCP indications used in publications by literature search.
Frequency (total times reported as an
Type of indication Indication
Clinical observation Pancreaticobiliary pain
Jaundice
Imaging abnormalities Imaging abnormality of the bile duct
Objective laboratory data Abnormal liver function tests
Procedural intention Change/removal of stent
Suspected or apparent diagnosis Cholelithiasis
Malignant stenosis
Biliary leak
Chronic pancreatitis
Sphincter of Oddi dysfunction
Benign stenosis
Cholangitis
Acute pancreatitis
Biliary pancreatitis
Bile duct injury or trauma
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53,394 ERCP procedures. A summary of the publications
included in the study is shown in Table 3. The indications
found to be used in the reviewed literature are grouped and
shown in Table 4 in terms of how many papers utilized each
indication. For example, only two of 12 papers used Imaging
abnormalities as an indication for ERCP.
There were relatively few indications in categories that
were not based on pre-ERCP diagnoses. The most frequent
indication was stones, followed closely by malignant sten-
osis and biliary leak (reported 10 times each), and this pre-
ERCP diagnosis of stones was qualified as suspected five
times. There was only a single study in which stones/sus-
pected stones was not considered to be an indication for
ERCP [4]. Out of the indications that were not based on a
pre-ERCP diagnosis, the most frequent was jaundice
(reported six times).
Importantly, it is not made clear on the basis of which
parameters the suspected or apparent diagnoses were made.
Table 4 also shows the frequency with which defining param-
eters were mentioned, specifically for indications that presup-
pose a diagnosis. When suspected or apparent diagnoses
were provided as indications, defining parameters were pro-
vided in only 8% of the cases. As examples, Christensen et al.
[5] described the basis of suspected stones as Suspected bile
duct stones at ultrasound, magnetic resonance or chol-
angiography. An American prospective study using the
American Society for Gastrointestinal Endoscopys (ASGE)
indications [6] described the basis of a pancreatic malignancy
as signs/symptoms suggesting pancreatic malignancy when
direct imaging is equivocal or normal [7]. Notwithstanding
these examples, in the majority of cases where suspected or
apparent diagnoses were used as indications, no definitions
of the diagnoses were stated and there was no mention of
which signs, symptoms or investigation results led to sus-
pected diagnoses. In short, the majority of ERCP indications
are provided as suspected or apparent diagnoses, and with-
out definition, it is not clear how objectively these diagnoses
were made nor how justified were the suspicions of the diag-
nosis, in which a suspected diagnosis was used as an
indication.
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY 5
Frequency (number of times reported
indication) with defining criteria)
3
6
2
5
5
11 1
10 2
10 0
9 1
8 1
7 1
7 0
4 0
3 0
3 0
New a-priori system for ERCP indications and its
evaluation
ERCP indications were closely associated with the ERCP find-
ings. Figures 2 and 3 show for each ERCP indication the
respective ERCP findings. Statistical analysis of the results is
shown in Table 5.
Primary indications (listed in Table 1)
Eight hundred and seventy-six patients (49.8%) had primary
indications. The most common primary indication was
change/removal of stent for benign disease (16.2%). As
expected, well over half the patients with the indication of
cholangitis had stones. Similarly, patients whose indication
was an abnormal IOC during cholecystectomy had a finding
of common bile duct stone at subsequent ERCP in 52.5% of
cases (74 of 141 cases). However, in keeping with previous
studies a substantial proportion of patients with abnormal
IOC were found to have normal cholangiograms at ERCP (51
of 141 cases) [8]. Of the patients who underwent ERCP for
clinical evidence of a bile leak, cholangiographic evidence of
a bile leak was found in 25 out of 44 cases. Of the 193
patients undergoing ERCP for acute pancreatitis, 91 were nor-
mal and 44 had a stone at ERCP, reflecting the fact that small
stones, which may not be evident at ERCP, often cause pan-
creatitis. Acute biliary pancreatitis was associated with no
cholangiogram being obtained (31 of 193 cases, v2(1) 10.1,
p .001). The failure to gain access to the biliary tree in
these cases may be attributable to swelling and distortion of
the ampulla and the neighboring duodenum related to pan-
creatic swelling.
Secondary indications (used only if patients did not fall
into one of the six primary indications)
Eight hundred and eighty-two patients (50.2%) had second-
ary indications at least two of pain (P), imaging evidence
(I), and significant abnormalities in LFTs (L).
The subtypes of the secondary indications were predictive
of ERCP findings. The subtype with both imaging abnormal-
ities and LFT abnormalities (IL) and the subtype with all
 6 N. YUEN ET AL.

Findings of ERCP in those performed for primary indicaons

100%
11 6 18
5
4 31 8
90%
11 5
2
80% 8
51 85
70% 19 25

Biliary leak
60% 91
9 N/A
1 39
50%
Other
48 23
40% Normal
6
101 Dilated duct
30% 23
2 74 Stricture
2
20% 111 CBD stone
6

10% 44
2
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2
0% 1 2
Cholangis Biliary AP IOC C/ROSM C/ROSB
leak
Primary indicaons
Figure 2. Percentages of the endoscopic retrograde cholangiopancreatography (ERCP) findings in those performed with primary indications. AP: acute (biliary) pan-
creatitis; IOC: intraoperative cholangiogram; C/ROSM: change or removal of stent for malignant disease; C/ROSB: change or removal of stent for benign disease.

Findings of ERCP in those performed for secondary indicatons

100%
45 3 9 5
90% 3 3 31
51 10
80% 4 9
9
47 10
70%
59
14 N/A
60% 104
15 Other
50%
3 Normal
40% 11 113 Dilated duct
4
30% 11 Stricture
225 23 6 CBD Stone
20%
35
10% 8
12
0%
PIL PI PL IL Other
Seconary indicaons
Figure 3. Percentages of the endoscopic retrograde cholangiopancreatography (ERCP) findings in those performed with secondary indications. P: epigastric or
right upper quadrant pain; I: imaging suggestive of significant abnormalities of the bile duct; L: significant abnormalities in LFTs.

three components (PIL) were both associated with the pres-
ence of biliary stricture (113 of 179 cases, v2(1) 255,
p < .001, and 104 of 475 cases, v2(1) 3.8, p .049, respect-
ively). Only if all three components (PIL) were present, there
was a statistically significant association with choledocholi-
thiasis (225 of 475 cases, v2(1) 35.3, p < .001). Conversely,
the secondary indication combination of pain and imaging
abnormalities (PI) was associated with a finding of dilated
bile duct (14 of 53 cases, v2(1) 18.2, p < .001) and the
absence of stricture (3 of 53 cases, v2(1) 6.2, p .012). The
subtype of pain and LFT abnormalities (PL) was associated
with normal cholangiography at ERCP (59 of 128 cases,
v2(1) 44.8, p < .001), but negatively associated both with
stones (35 of 128 cases, v2(1) 4.7, p .031) and stricture (11
of 128 cases, v2(1) 9.5, p .002).
Adverse events
Figure 4 shows the ERCP indications compared against the
occurrence of post-ERCP adverse events. Only two ERCP indi-
cations were significantly associated with the occurrence of
adverse events: the combination subtype with PI (15 of 53
cases, v2(1) 17.0, p < .001), and the other group (10 of 47
cases, v2(1) 5.3, p .021). Each was significantly associated
with unplanned/prolonged hospitalization from all adverse
events. Interestingly, neither PI nor other were significantly
 SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY 7

Table 5. P-values for associations according to ERCP indication.

ERCP findings
ERCP indications Biliary leak Dilated duct Normal N/A Other Stone Stricture Complication
(PIL) 0.731 0.000 0.865 0.013 0.000 0.049 0.983
(PI) 0.000 0.536 0.316 0.624 0.267 0.012 0.000
(PL) 0.717 0.000 0.294 0.738 0.031 0.002 0.076
(IL) 0.060 0.000 0.000 0.805 0.000 0.000 0.889
Acute (biliary) pancreatitis 0.225 0.000 0.001 0.421 0.000 0.000 0.148
Biliary leak 0.000 0.256 0.160 0.310 0.218 0.000 0.014 0.062
C/ROSB 0.008 0.001 0.038 0.276 0.266 0.000 0.022
C/ROSM 0.011 0.008 0.721 0.630 0.000 0.000 0.135
Cholangitis 0.056 0.000 0.267 0.541 0.000 0.030 0.192
IOC 0.188 0.000 0.023 0.108 0.000 0.000 0.499
Other 1.000 0.111 0.801 0.000 0.006 0.277 0.021
Entries in bold indicate statistically significant associations (p < .05) that are positive in nature. Entries in italic indicate statistically significant associations
(p < .05) that are negative in nature. C/ROSB: change or removal of stent for benign disease. C/ROSM: change or removal of stent for malignant disease; IOC:
intraoperative cholangiogram.
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ERCP related adverse events according to ERCP indicaons

100%

90%

80%

70%
38
60% 37 No adverse
423 108 166
160 264 142 128 events
50% 43 57
Adverse
40%
events
30%

20%
15
10% 10
52 20 27
19 20 12 13
0% 1 3

Indicaons
Figure 4. Percentages of endoscopic retrograde cholangiopancreatography (ERCP) related adverse events according to ERCP indications.

associated with post-ERCP pancreatitis. The unplanned/pro-
longed hospitalization was thus due to factors other than
post-ERCP pancreatitis.
Discussion
For a new indication system for ERCP to be considered use-
ful, it should be established that: first, it constitutes a signifi-
cant improvement on currently used indication criteria and
second, it is helpful in predicting, on the one hand, which
patients are most likely to benefit from ERCP and on the
other hand, in which patients ERCP constitute an unaccept-
able risk.
Regarding the first aim, it is clear that in previous series of
unselected ERCPs there has been widespread use of ERCP
indications that pre-suppose diagnoses or suspected diagno-
ses. This could be reflective of the trend away from using
diagnostic ERCP in favor of therapeutic ERCP [2]. This trend
may have influenced the classification of ERCP indications as
it is easier to define therapeutic goals if there has been a
presumptive diagnosis made before the procedure. However,
such an approach is intrinsically unscientific as presupposing
a diagnosis can never substitute for an objective evaluation
of a patient before the diagnosis (and any associated therapy
such as sphincterotomy or biliary stenting performed during
ERCP) is made. Although the a-priori indication system that
was used in our study uses some indications that presuppose
a diagnosis (e.g., acute biliary pancreatitis and cholangitis) as
primary indications, the diagnoses we used as indications, in
contradistinction to previous unselected series, were carefully
defined by clear clinical parameters that could be ascertained
prior to ERCP.
The new classification system was shown to be predictive
of findings found at ERCP. This was entirely expected for
indications such as cholangitis in which a majority of affected
patients had stones demonstrated within the common bile
duct. The other primary indications [clinical evidence of bil-
iary leak, acute (biliary) pancreatitis, abnormal IOC, change/
removal of stent for benign disease, and change/removal of
stent for malignant disease] are also uncontroversial and the
findings in patients with these indications were also unsur-
prising. The exact clinical context in which acute biliary pan-
creatitis should lead to an ERCP and the timing of such an
 8 N. YUEN ET AL.

ERCP are hotly debated in the literature [9]. It is clear none-
theless that biliary pancreatitis is an appropriate indication
for ERCP in many instances. There are other causes of pan-
creatitis, for which ERCP has been used but these are either
quite rare (pancreas divisum) or controversial (idiopathic pan-
creatitis without any evidence of gallstone disease). In add-
ition, the pre-procedure exclusion of IgG4-related pancreatic
disease may be important in some clinical scenarios.
The proposed classification system is not only worthwhile
for the relatively uncontroversial and straightforward primary
indications, but also contributes significantly to establishing a
system of indications in clinical scenarios in which the role of
ERCP is not so clear. Abdominal pain, imaging abnormalities
of the bile duct, and deranged LFTs were used as secondary
indications. Different combinations of these parameters,
which do not presuppose a diagnosis, have different associa-
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been previously reported by our group [16]. In addition, pan-
creatic indications such as endotherapy for pancreatic ductal
strictures and stones, minor ampullary pancreatic sphincterot-
omy for recurrent pancreatitis in the context of pancreas divi-
sum are also uncommon and often performed in quaternary
referral centres. The development of indication classification
systems related to these more uncommon scenarios would
be complementary rather than competitive to the indications
classification system outlined in the current study. Sphincter
of Oddi dysfunction or suspected sphincter of Oddi dys-
function was avoided as indications as this also presupposes
a pre-procedure diagnosis or suspected diagnosis. The exact
nature of this entity is controversial in any case [17].
The presented classification system is only a starting point
for refining indications in ERCP. It is often the pattern of the
symptoms and investigation abnormalities which can sway a

tions with ERCP findings. Patients presenting with the com-
bination of PI commonly had a subsequent ERCP that
demonstrated the presence of a dilated bile duct in the
absence of a stricture or stone. The combination of PIL was
similarly associated with subsequent ERCP demonstration of
stones and strictures. The combination of PL was, however,
associated with a normal cholangiogram a finding that is
less likely to lead to an ERCP-related benefit. Interestingly,
the combination of IL was associated with lack of access
into the bile duct. This analysis of secondary indications
shows that patients with status of PI and PL may require
additional evidence before ERCP is considered. In this
respect, endoscopic ultrasound may have a significant role as
it becomes more widespread and refined.
These findings complement research that supports the
idea that a greater focus on objective parameters can result
in indications for ERCP that reduce unnecessary procedures
[1013]. Parnaby et al. [10] in a small study of 153 consecu-
tive patients developed an algorithm based on clinical,
laboratory, and radiological data and showed that this pre-
dicted the need for ERCP. With respect to choledocholithiasis,
Jovanovic et al. [12] have also evaluated an effective model
for predicting the need for therapeutic ERCP using biochem-
ical and ultrasound results.
It is acknowledged that a similar approach to ours has
been used previously but only in terms of attempting to
determine the likelihood of choledocholithiasis. In an ASGE
endorsed guideline, Maple et al. [13] proposed a series of
parameters to determine the likelihood of choledocholithia-
sis. Adams et al. [14] and Suarez et al. [15], however, have
found these criteria to be lacking in diagnostic accuracy. In
addition, some of the parameters used in the ASGE guideline
were not precisely defined: clinical gallstone pancreatitis
and clinical ascending cholangitis.
It is also acknowledged that our classification system can-
not cover all the scenarios in which ERCP is indicated.
Uncommon indications such as an ampullary lesion requiring
ampullectomy and rendezvous procedures for previously
percutaneously placed transhepatic catheters have unique
endoscopic challenges and adverse event profiles. This is
confirmed in our study, in which unusual indications (other)
were shown to predict a greater risk of unplanned hospital-
ization/prolongation of hospital stay. These findings have
clinician to proceed with ERCP. For instance, a sudden
change in LFTs and a sudden resolution or partial resolution
increase the likelihood of choledocholithiasis being found.
Similarly, severe pain with sudden onset is more suggestive
of choledocholithiasis rather than a chronic mild pain of less
acute onset. Specifying these patterns in indication defini-
tions, however, risks over-defining without any improvement
in objectivity.
In conclusion, we have presented an ERCP indication clas-
sification system, which is simple, easy to understand and
intrinsically more scientific than its predecessors. In our ser-
ies, it has been shown to be useful in predicting the success
rate, findings, and adverse events of ERCP and we are confi-
dent that it will prove useful in advancing the science of
ERCP in general and thereby in the longer-term reducing
unnecessary procedures and their related morbidity and
mortality.
Acknowledgements
The authors thank Dr. Linda Lee of The Brigham and Womens Hospital,
Boston, for her help in reviewing this paper.
Disclosure statement
No potential conflict of interest was reported by the authors.
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