Grading ERCPs by degree of difficulty: a new concept to

produce more meaningful outcome data

Stephen M. Schutz, MD, Robert M. Abbott, MD
San Antonio, Texas

Background: Simple endoscopic retrograde cholangiopancreatography (ERCP) outcome mea-

sures such as success and complication rates may not allow direct comparisons among endos-
copists or centers because procedure degree of difficulty can vary tremendously from case to
case. We propose a new grading scale designed to objectively quantify ERCP degree of difficulty.
Methods: A 1 to 5 scale was devised to grade ERCPs according to their level of technical difficulty.
A retrospective pilot study was performed to assess ERCP outcomes at our institution according
to difficulty grade. The scale was then prospectively applied to all ERCPs during a 1-year period.
Results: In the pilot study, 209 of 231 (90%) ERCPs were technically successful, and 8 (3%) were
followed by complications. Grade 1 to 4 procedures were more likely to succeed (94% vs. 74%,
p < 0.05) and less likely to have associated complications (2% vs. 10%, p < 0.05) than grade 5/5B
ERCPs. Of 187 ERCPs assessed prospectively, 166 (89%) were successful and 10 (5%) were fol-
lowed by complications; 132 of 138 (96%) grade 1 to 4 procedures succeeded compared with 30
of 46 grade 5 to 5B ERCPs (65%, p < 0.001), but complications were not significantly more frequent
in grade 5 to 5B ERCPs (8.7% vs. 4.3%, p = not significant).
Conclusions: Technical success was dependent on ERCP degree of difficulty, but complications
were not. Outcome data that incorporate degree of difficulty information may be more meaningful,
allowing endoscopist-to-endoscopist and center-to-center comparisons. (Gastrointest Endosc
2000;51:535-9.)

As for many medical procedures, ERCP outcomes
are reported in terms of procedural success and
complication rates. In general, technical success
should be defined on an intention-to-diagnose and
intention-to-treat basis, and a consensus conference
has standardized ERCP complication definitions.1
Although technical success and complication data
are useful in assessing procedure quality, taken by
themselves they are relatively crude measures of
outcome.
A large multicenter prospective study by Freeman
et al.2 found that numerous patient-specific and
endoscopist-specific factors significantly impact the
risk of complications after biliary sphincterotomy.
Similarly, technical success may vary markedly
depending on many factors, particularly the type of
intervention being attempted. When biliary sphinc-
terotomy is attempted or when the goal is to remove
single small stones from the bile duct, for example,
Received May 25, 1999. For revision August 30, 1999. Accepted
December 9, 1999.
From the Departments of Gastroenterology and Radiology, Wilford
Hall Medical Center, San Antonio, Texas.
Presented in part at the annual ASGE meeting May 18, 1999,
Orlando, Florida.
Reprint requests: Stephen M. Schutz, MD, Chief, Division of
Gastroenterology, David Grant Medical Center, 101 Bodin Ci,
Travis AFB, CA 94535.
37/1/104980
doi:10.1067/mge.2000.104980
ERCP is almost always successful.3,4 Extracting cal-
culi from intrahepatic bile ducts or the pancreas, on
the other hand, is much more likely to result in a
technical failure.5-7
Although interventional cardiologists have devel-
oped a system to grade the technical difficulty of
coronary artery lesions prior to angioplasty,8 there
is presently no objective way to quantify ERCP
degree of difficulty. In an attempt to give technical
success information from our center additional con-
text, a relatively simple ERCP degree of difficulty
grading scale was developed, pilot tested by apply-
ing it retrospectively to our 1997 outcome data, and
then used to prospectively grade ERCPs at our cen-
ter during 1998.
METHODS
Demographic and procedural information for all
ERCPs done at our center is entered into a database
(GITrac; Akron Systems Development, Charleston, S.C.)
immediately after each procedure. In addition, all ERCPs
performed during the previous week are reviewed at an
afternoon conference attended by a majority of gastroen-
terology fellows and attending physicians at our center, as
well as a radiologist (R.A.) with expertise in ERCP inter-
pretation. At this conference, technical success and com-
plication determinations are made for each scheduled pro-
cedure, and any additional details about earlier ERCPs
(e.g., late complications) are noted. Although patients
were not contacted routinely after ERCP to capture com-
plications, it is unlikely that they would have occurred

VOLUME 51, NO. 5, 2000 GASTROINTESTINAL ENDOSCOPY 535

S Schutz, R Abbott Grading ERCPs by degree of difficulty, more meaningful outcome data

Table 1. Summary of ERCP degree of difficulty grading scale

Grade 1: simple diagnostic ERCP
Grade 2: simple therapeutic ERCP
Grade 3: complex diagnostic ERCP
Grade 4: complex therapeutic ERCP
Grade 5: very advanced ERCP
Biliary procedures
Standard diagnostic cholangiogram
Standard biliary sphincterotomy; removal
of 1-2 small common duct stones ( 1 cm);
nasobiliary drain placement
Diagnostic cholangiogram, Billroth II
anatomy; biliary cytology
Multiple ( 3) or large (> 1 cm) common
duct stones; cystic duct or gallbladder
stone removal; common duct stricture
dilation; common duct stenting
(plastic or metal)
Precut biliary sphincterotomy; stone removal
with lithotripsy (any type); intrahepatic
stone removal; intrahepatic stricture
dilation; biliary therapy, Billroth II anatomy;
cholangioscopy
Pancreatic procedures
Standard diagnostic pancreatogram
Not applicable
Diagnostic pancreatogram, Billroth II anatomy;
minor papilla cannulation; pancreatic cytology
Not applicable
All pancreatic therapy (pancreatic sphincterotomy,
stenting, stricture dilation, or stone removal,
any minor papilla therapy); any pseudocyst
drainage (transpapillary, transgastric,
transduodenal); pancreatoscopy

If an ERCP was previously unsuccessful, it was given a B modifier.

without our knowledge because we operate in a closed sys-
tem. Technical success is determined on an intention-to-
diagnose and intention-to-treat basis, and complications
are defined according to published criteria.1 Any differ-
ences of opinion are discussed, and a final determination
is arrived at by consensus.
In late 1997, one of the authors with advanced training
and interest in ERCP (S.M.S.) developed a 1 to 5 ERCP
degree of difficulty grading scale (Table 1). If an ERCP
was previously unsuccessful, it was given a B modifier
(e.g., a diagnostic cholangiogram that was unsuccessful at
another center was a grade 1B). As part of a pilot study,
this scale was applied retroactively to ERCPs performed
during calendar year 1997, which were reviewed and
assigned a difficulty grade based on the type of interven-
tion performed, if any. Procedures involving more than
one intervention received the highest applicable grade
based on procedure intent (e.g., an ERCP that involved a
biliary sphincterotomy and pancreatic stent insertion
would be a grade 5 procedure. If the sphincterotomy suc-
ceeded and stent insertion was unsuccessful, this would
be graded as a failed grade 5 procedure).
After analysis of the retrospective 1997 data, our scale
was applied to individual ERCPs prospectively, beginning
with the first ERCP conference in January 1998. As noted
above, ERCP technical success is assessed at our weekly
conference based on the intent of the procedure, which is
usually, but not always, known before the procedure. For
example, the intent of an endoscopist faced with a jaun-
diced elderly patient with CT-proven dilated bile ducts
and a pancreatic mass is to place a biliary stent, even if he
or she is unable to reach the papilla due to duodenal com-
pression. Conversely, the intent of an endoscopist per-
forming ERCP to evaluate presumed pancreatic pain, who
then finds bile duct stones and a normal pancreatogram,
is to remove the stones.)
In both the retrospective and prospective studies,
grades 1 to 4B and 5 to 5B ERCPs were compared to assess
differences in technical success. These groups were select-
ed for comparison because all endoscopists performing
ERCP should be able to do grade 1 to 4 ERCPs, whereas
grade 5 to 5B procedures may be more appropriate for
expert endoscopists. Grades 1 to 4B and 5 to 5B procedures
were compared using the Fisher exact test, and p values of
< 0.05 were considered to be statistically significant.
RESULTS
Retrospective pilot study
In 1997 our unit performed 231 ERCPs; 192
(83%) were grade 1 to 4 procedures, and 39 (17%)
were grade 5 or 5B (Table 2). Analysis of outcomes
revealed a technical success rate for grade 1 to 4B
ERCPs of 94% (180 of 192 procedures) but only 74%
(29 of 39 ERCPs) for grade 5 and 5B cases (p =
0.028, Fisher exact test). Grade 5 and 5B ERCPs
were also more likely to be associated with compli-
cations than those of grades 1 to 4B (10% vs. 2%, p
= 0.028, Fisher exact test).
Prospective study
We performed 187 ERCPs in 1998 (Table 3); 166
(89%) were technically successful. Failed procedures
included grade 1, diagnostic cholangiogram/pancre-
atogram (n = 3); grade 1B, diagnostic pancreatogram
(n = 1); grade 4, biliary sphincterotomy (succeeded)
plus removal of cystic duct stones (failed) (n = 1);
grade 5, common duct biliary stent status post -1
Billroth II gastrectomy (n = 1), precut for biliary
access (n = 2), mechanical lithotripsy of bile duct
stone (n = 1), pancreatic duct sphincterotomy plus
stent insertion (n = 2), pancreatic duct stent place-
ment (n = 1); grade 5B, cystic duct stricture dilation
plus stent placement via cholecystoduodenostomy
(n = 1), pancreatic duct sphincterotomy plus stent

536 GASTROINTESTINAL ENDOSCOPY VOLUME 51, NO. 5, 2000

Grading ERCPs by degree of difficulty, more meaningful outcome data S Schutz, R Abbott

Table 2. Retrospective ERCP outcomes by difficulty grade (January 1,

1997-December 31, 1997)
N (%) Technical success (%) Complications (%)
Grade 1 106 (46%) 98 (92%) 3 (3%)
Grade 1B 2 (1%) 1 (50%) 0 (0%)
Grade 2 35 (15%) 35 (100%) 0 (0%)
Grade 3 5 (2%) 4 (80%) 1 (20%)
Grade 4 42 (18%) 40 (95%) 0 (0%)
Grade 4B 2 (1%) 2 (100%) 0 (0%)
Grade 5 32 (14%) 27 (84%) 3 (9%)
Grade 5B 7 (3%) 2 (28%) 1 (17%)
Total 231 ( 209 (90%) 8 (3%)

Table 3. Prospective ERCP outcomes by difficulty grade (January 1, 1998-

December 31, 1998)
N (%) Technical success (%) Complications (%)
Grade 1 68 (36.5%) 65 (96%) 1 (1.5%)
Grade 1B 1 (0.5%) 0 (0%) 0 (0%)
Grade 2 33 (18%) 33 (100%) 3 (10%)
Grade 3 6 (3%) 6 (100%) 1 (17%)
Grade 4 32 (17%) 31 (97%) 1 (3%)
Grade 5 35 (18%) 28 (79%) 2 (6%)
Grade 5B 12 (7%) 3 (25%) 2 (17%)
Total 187 166 (89%) 10 (5%)

insertion (n = 2), pancreatic duct stricture dilation
plus stent placement (n = 1), minor papilla stent
plus sphincterotomy (n = 2), transpapillary pseudo-
cyst drainage (n = 2), pancreatoscopy/pancreatic
duct stone laser lithotripsy (n = 1).
Ten of 187 ERCPs (5%) were associated with com-
plications: grade 1, 1 moderate pancreatitis; grade 2,
1 severe bleeding, 1 mild pancreatitis, 1 mild cholan-
gitis; grade 3, 1 mild cholangitis; grade 4, 1 mild
cholangitis; grade 5, 1 mild fever, 1 mild pancreati-
tis; and grade 5B, 1 moderate pancreatitis, 1 moder-
ate infection (candidal infection of a pseudocyst fol-
lowing a failed attempt at transpapillary drainage).
Thirty-five percent of grade 5 to 5B ERCPs were
unsuccessful (16 of 46), compared with only 4% of
grade 1 to 4 procedures (5 of 138, p < 0.001).
However, complications were not significantly more
frequent in grade 5 to 5B ERCPs (8.7% vs. 4.3%, p =
not significant).
DISCUSSION
Currently, standardized means of assessing
patient illness such as the American Society of
Anesthesiology (ASA) scores are widely used to esti-
mate risk of some procedure complications. In addi-
tion, Fleischer et al.8 have developed an inventive
system for classifying and grading such complica-
tions by quantifying their negative repercussions.
However, there is presently no objective way to put
ERCP technical failures into perspective by quanti-
fying procedural degree of difficulty. Practitioners of
coronary angioplasty have utilized a lesion-specific
grading scale to objectively estimate technical diffi-
culty for many years.9 In this system, A lesions are
minimally difficult (expected technical success rate
85% or greater), B stenoses are moderately com-
plex (expected success rate 60% to 85%), and C
lesions are very challenging (expected success rate
less than 60%). Similarly, our system uses an easily
understandable 1 to 5 scale to quantify ERCP
degree of difficulty in a way that we believe mini-
mizes bias due to varying skill levels of individual
endoscopists.
Our grading scale does not directly address the
fact that some grade 1 or 2 ERCPs are much more
difficult than those with a higher grade. In fact,
although our retrospective data from 1997 show
that grade 5 to 5B ERCPs carry a higher rate of
technical failure than lower grade procedures, we
also saw proportionately (but not significantly) more
failures in grades 1 and 3 than grades 2 and 4. Our
study sample is relatively small, though, and the
procedure outcomes reported reflect the capabilities
of a single center. It is our belief that this scale will
reveal sequentially higher technical failure rates
with increasing procedure grades when large num-
bers of ERCPs are analyzed, particularly if the pro-
cedures are performed at a variety of centers by a
spectrum of endoscopists. However, further study
would be needed to substantiate this hypothesis.

VOLUME 51, NO. 5, 2000 GASTROINTESTINAL ENDOSCOPY 537

S Schutz, R Abbott
Even if future studies do not show a significant
drop in the probability of technical success as out-
comes are assessed for grade 1 through 4 ERCPs in
sequence, stratifying procedures in this way has
other uses. Such a scale could be used in training
advancing endoscopy fellows in a stepwise fashion.
Second-year trainees might be allowed to partici-
pate in grade 1 maneuvers and third-year fellows in
grade 2 and 4 interventions, whereas grade 5
ERCPs would be reserved for advanced trainees
only. In addition, credentialing or billing uses could
be envisioned. A hospital might credential an endos-
copist for grade 1 and 2 ERCPs but not higher grade
procedures, thereby dissuading a less qualified
endoscopist from performing an ill-advised precut,
for example. A system that reflects the increased
degree of difficulty involved in some ERCPs might
provide justification for billing for the additional
accessories used with procedures such as biliary
stent placement.
The fact that the retrospective pilot study and the
prospective study both demonstrated that grade 5 to
5B ERCPs are significantly more likely to fail than
lower grade procedures is important for two rea-
sons. (1) If no allowance were made for ERCP degree
of difficulty, an endoscopist who attempts only grade
1 to 4 procedures would be rewarded with impres-
sive technical success rates. In fact, at our center we
would have been able to boast of a 96% success rate
in 1998 if we had not taken on grade 5 to 5B cases.
(2) Many endoscopists who perform ERCP do not
routinely attempt grade 5 procedures and send such
cases to centers with high levels of expertise. The
finding that grade 5 to 5B ERCPs in our study were
much more likely to fail than grade 1 to 4 proce-
dures suggests that highly advanced procedures
may be more appropriate for endoscopists at referral
centers without an initial attempt at the procedure.
A related issue is the success rate of B, or pre-
viously unsuccessful, procedures in our study. When
these ERCPs were analyzed separately, we found
that only 8 of 24 (33%) of B procedures succeeded
compared with 367 of 394 (93%) non-B ERCPs (p <
0.001). When compared with a second-attempt suc-
cess rate of 96% at one expert center,10 these results
are not encouraging and suggest that it may be bet-
ter to send these cases to a referral institution.
At present, our scale does not take into account
prior sphincterotomy or stent placement of the
desired duct. Only a small subset of our cases had
had such prior interventions, but a center with
many such cases would need to address this in some
way, perhaps with an S suffix (similar to our B
modifier for prior failed ERCPs).
Although this scale was developed primarily with
538 GASTROINTESTINAL ENDOSCOPY
Grading ERCPs by degree of difficulty, more meaningful outcome data
technical failures in mind, it may have relevance for
complications. Our retrospective pilot study found
that grade 5 to 5B ERCPs were significantly more
likely to be associated with complications compared
with lower grade procedures (10% vs. 2%, p < 0.05),
but this was not the case in the prospective study. It
would be valuable to determine whether complica-
tions also increase with higher difficulty grades
when the scale is tested on large numbers of ERCPs
performed at a variety of centers.
One advantage of our scale is the ability to add
unusual and unique procedures as technology
advances. Nevertheless, in rare circumstances such
a highly exceptional procedure would not fit easily
into this grading scale. One example in our study
was an attempted cystic duct dilation/stent place-
ment in a man who had undergone a cholecystoduo-
denostomy shortly after birth for duodenal atresia
and had developed jaundice due to stricturing of the
cystic duct 20 years later. Because the ERCP we
attempted involved maneuvering the duodenoscope
into the gallbladder and then advancing a wire
through the cystic duct into the biliary tree, we cat-
egorized this procedure as grade 5.
Our scale represents a preliminary attempt to
establish an ERCP degree of difficulty grading sys-
tem to add context to technical success data. We
believe that such a system would enable practition-
ers (and others) to objectively assess procedural
degree of difficulty, allowing meaningful compar-
isons among endoscopists, centers, or geographical
regions. This scale may also be useful with respect to
ERCP training, credentialing, and billing. Before
any scale could be adopted for general use, however,
more study and wider input from expert endos-
copistsideally at a consensus conferencewould
be necessary.
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