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 measures such as success and complication rates may not allow direct comparisons among endoscopists 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 followed 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 sphincterotomy 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 VOLUME 51, NO. 5, 2000

ERCP is almost always successful.3,4 Extracting calculi 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 developed 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 context, a relatively simple ERCP degree of difficulty grading scale was developed, pilot tested by applying it retrospectively to our 1997 outcome data, and then used to prospectively grade ERCPs at our center 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 gastroenterology fellows and attending physicians at our center, as well as a radiologist (R.A.) with expertise in ERCP interpretation. At this conference, technical success and complication determinations are made for each scheduled procedure, and any additional details about earlier ERCPs (e.g., late complications) are noted. Although patients were not contacted routinely after ERCP to capture complications, it is unlikely that they would have occurred
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Table 1. Summary of ERCP degree of difficulty grading scale

Biliary procedures Grade 1: simple diagnostic ERCP Grade 2: simple therapeutic ERCP 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

Grade 3: complex diagnostic ERCP Grade 4: complex therapeutic ERCP

Diagnostic pancreatogram, Billroth II anatomy; minor papilla cannulation; pancreatic cytology Not applicable

Grade 5: very advanced ERCP

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 system. Technical success is determined on an intention-todiagnose and intention-to-treat basis, and complications are defined according to published criteria.1 Any differences 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 intervention 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 succeeded 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 jaundiced 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 compression. Conversely, the intent of an endoscopist performing 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 select536 GASTROINTESTINAL ENDOSCOPY

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 complications 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/pancreatogram (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 placement (n = 1); grade 5B, cystic duct stricture dilation plus stent placement via cholecystoduodenostomy (n = 1), pancreatic duct sphincterotomy plus stent
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Table 2. Retrospective ERCP outcomes by difficulty grade (January 1, 1997-December 31, 1997)
N (%) Grade Grade Grade Grade Grade Grade Grade Grade Total 1 1B 2 3 4 4B 5 5B 106 2 35 5 42 2 32 7 231 (46%) (1%) (15%) (2%) (18%) (1%) (14%) (3%) ( Technical success (%) 98 1 35 4 40 2 27 2 209 (92%) (50%) (100%) (80%) (95%) (100%) (84%) (28%) (90%) Complications (%) 3 0 0 1 0 0 3 1 8 (3%) (0%) (0%) (20%) (0%) (0%) (9%) (17%) (3%)

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

insertion (n = 2), pancreatic duct stricture dilation plus stent placement (n = 1), minor papilla stent plus sphincterotomy (n = 2), transpapillary pseudocyst drainage (n = 2), pancreatoscopy/pancreatic duct stone laser lithotripsy (n = 1). Ten of 187 ERCPs (5%) were associated with complications: grade 1, 1 moderate pancreatitis; grade 2, 1 severe bleeding, 1 mild pancreatitis, 1 mild cholangitis; grade 3, 1 mild cholangitis; grade 4, 1 mild cholangitis; grade 5, 1 mild fever, 1 mild pancreatitis; and grade 5B, 1 moderate pancreatitis, 1 moderate infection (candidal infection of a pseudocyst following 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 estimate risk of some procedure complications. In addition, Fleischer et al.8 have developed an inventive system for classifying and grading such complications by quantifying their negative repercussions. However, there is presently no objective way to put ERCP technical failures into perspective by quantiVOLUME 51, NO. 5, 2000

fying procedural degree of difficulty. Practitioners of coronary angioplasty have utilized a lesion-specific grading scale to objectively estimate technical difficulty for many years.9 In this system, A lesions are minimally difficult (expected technical success rate 85% or greater), B stenoses are moderately complex (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 minimizes 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 numbers of ERCPs are analyzed, particularly if the procedures are performed at a variety of centers by a spectrum of endoscopists. However, further study would be needed to substantiate this hypothesis.
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Even if future studies do not show a significant drop in the probability of technical success as outcomes 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 participate 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 endoscopist 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 reasons. (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 impressive 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 procedures 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 previously 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 success rate of 96% at one expert center,10 these results are not encouraging and suggest that it may be better 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
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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 complications 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 placement in a man who had undergone a cholecystoduodenostomy 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 categorized this procedure as grade 5. Our scale represents a preliminary attempt to establish an ERCP degree of difficulty grading system to add context to technical success data. We believe that such a system would enable practitioners (and others) to objectively assess procedural degree of difficulty, allowing meaningful comparisons 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 endoscopistsideally at a consensus conferencewould be necessary.
REFERENCES
1. Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RCG, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383-93. 2. Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, et al. Complications of endoscopic biliary sphincterotomy. N Engl J Med 1996;335:909-18. 3. Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, et al. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc 1998;48:1-10. 4. Baillie J. Common bile duct stones. ASGE Clinical Update 1998;5:1-4. 5. Leung JWC, Venezuela RR, Banez VP, Chung SCS, Lau JWY, Li AKC. Endoscopic management of intrahepatic stones. Gastrointest Endosc 1991;37:256-61. 6. Grimm H, Meyer WH, Nam VC, Soehendra N. New modalities for treating chronic pancreatitis. Endoscopy 1989;21:70-4. 7. Cremer M, Deviere J, Delhaye M, Baize M, Vendermeeren A. VOLUME 51, NO. 5, 2000

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Stenting in severe chronic pancreatitis: results of mediumterm follow-up in 76 patients. Endoscopy 1991;23:171-6. 8. Fleischer DE, Van de Mierop F, Eisen GM, Al-Kiwas FH, Benjamin SB, Lewis JH, et al. A new system for defining endoscopic complications emphasizing the measure of importance. Gastrointest Endosc 1997;45:128-33.

9. Ryan TJ, Faxon DP, Gunnar RM, Kennedy JW, King SB, Loop FD, et al. Guidelines for percutaneous transluminal coronary angioplasty. J Am Coll Cardiol 1988;12:529-45. 10. Kumar S, Sherman S, Hawes RH, Lehman GA. Success and yield of second attempt ERCP. Gastrointest Endosc 1995;41: 445-7.

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