ercp complication rates: how low can we go?

3
EDITORIAL ERCP complication rates: how low can we go? Over the years, endoscopic procedures have made a steady migration from diagnostic examinations to thera- peutic interventions. With the current direction of NOTES (natural orifice transluminal endoscopic surgery), the line between an endoscopic procedure and surgical laparoscopy is becoming increasingly blurred. Probably the most signifi- cant advances in therapeutic endoscopy have been made in the field of ERCP. Through such an endoscopic approach, it is now commonplace to remove common bile duct stones, provide drainage for obstructed or injured ducts, and per- form transluminal drainage of pseudocysts. Risk factors for complications during or after ERCP may be patient, proce- dure, or operator related. What can we do to impact these risk factors and provide a safer procedure for our patients? How low can we go with complication rates? In this issue of Gastrointestinal Endoscopy , Cotton et al 1 present us with a retrospective review of ERCP complica- tions acquired from their database of over 11,000 proce- dures. The results are collected from a single U.S. center with expert endoscopists and with trainee involvement in most procedures. They report an impressive overall compli- cation rate of 4%, with a pancreatitis rate of 2.6%. The major- ity of these complications were rated mild, according to consensus criteria. 2 There are several shortcomings to this database analysis. The investigators acknowledge a potential for underreport- ing complications because postprocedure patient contact was not performed and the entry of ‘‘delayed’’ complica- tions was performed at 1 week or when notified of a compli- cation by an outside physician. Such a lack of direct contact could have resulted in a lower rate of delayed complications being recognized. Another area of concern is that the data for this study were collected at the time of the procedure, over a 12-year period, and were entered into a database that contains 105 categories. Over time, a large number of in- dividuals were responsible for data collection and entry, and the reliability and standardization of such data entry come into question. For entry items in which strict definitions were not established, the data itself are suspect. Such an ex- ample would be the definition of obesity as ‘‘clinical observa- tion at the time of procedure,’’ without other established criteria. Another entry item of concern is pancreatitis before the procedure, because it appears as though acute and chronic pancreatitis were grouped together. Such data be- come of questionable usefulness because of the lack of a strict definition of the condition. In addition, over 12 years, there is a continual enhancement of the database, with additions, deletions, or alterations of various data fields, and such changes could affect retrospective data analysis. Nevertheless, multivariate analysis of their data presents us with independent risk factors for the categories of overall complications, pancreatitis, bleeding, and severe or fatal complications. Their data of ERCP-related infections and antibiotic prophylaxis were reported in an earlier article. 3 As noted, the overall complication rate was 4%, with 73% of complications being rated as mild and 9% as severe and with a 2% fatality rate. This low overall complication rate is similar to studies by Loperfido et al 4 and Williams et al. 5 However, other studies reported higher complication rates, 6 including a review of 21 prospective studies of ERCP-related complications. 7 In the study by Cotton et al, 1 independent factors that were identified to increase the risk of overall complications included suspected sphincter of Oddi dysfunction (SOD) and the performance of a biliary sphincterotomy. They found that placement of a small-di- ameter pancreatic-duct stent (SDPDS) and the presence of pancreatitis before the procedure conferred some pro- tection against a procedure-related complication. In regard to the presence of pancreatitis before the ERCP, it is not clear what severity or chronicity of the disease was considered. Because both acute and chronic pancreatitis were allowed for this entry, one could assume that patients with a history of chronic pancreatitis might have experienced a lower rate of procedure-related pancreatitis. However, this was not ob- served. The group experienced a lower overall complica- tion rate but not a lower rate of pancreatitis, and this is difficult to explain. As expected, pancreatitis was the most common compli- cation, which occurred in 2.6% of cases. The study reports that patients with suspected SOD had a higher rate of Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 doi:10.1016/j.gie.2009.01.008 Risk factors for complications during or after ERCP may be patient, procedure, or operator related. www.giejournal.org Volume 70, No. 1 : 2009 GASTROINTESTINAL ENDOSCOPY 89

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Page 1: ERCP complication rates: how low can we go?

EDITORIAL

ERCP complication rates: how low can we go?

Over the years, endoscopic procedures have madea steady migration from diagnostic examinations to thera-peutic interventions. With the current direction of NOTES(natural orifice transluminal endoscopic surgery), the linebetween an endoscopic procedure and surgical laparoscopyis becoming increasingly blurred. Probably the most signifi-cant advances in therapeutic endoscopy have been made inthe field of ERCP. Through such an endoscopic approach, itis now commonplace to remove common bile duct stones,provide drainage for obstructed or injured ducts, and per-form transluminal drainage of pseudocysts. Risk factors forcomplications during or after ERCP may be patient, proce-dure, or operator related. What can we do to impact theserisk factors and provide a safer procedure for our patients?How low can we go with complication rates?

In this issue of Gastrointestinal Endoscopy, Cotton et al1

present us with a retrospective review of ERCP complica-tions acquired from their database of over 11,000 proce-dures. The results are collected from a single U.S. centerwith expert endoscopists and with trainee involvement inmost procedures. They report an impressive overall compli-cation rate of 4%, with a pancreatitis rate of 2.6%. The major-ity of these complications were rated mild, according toconsensus criteria.2

There are several shortcomings to this database analysis.The investigators acknowledge a potential for underreport-ing complications because postprocedure patient contactwas not performed and the entry of ‘‘delayed’’ complica-tions was performed at 1 week or when notified of a compli-cation by an outside physician. Such a lack of direct contactcould have resulted in a lower rate of delayed complicationsbeing recognized. Another area of concern is that the datafor this study were collected at the time of the procedure,over a 12-year period, and were entered into a databasethat contains 105 categories. Over time, a large number of in-dividuals were responsible for data collection and entry, andthe reliability and standardization of such data entry comeinto question. For entry items in which strict definitionswere not established, the data itself are suspect. Such an ex-ample would be the definition of obesity as ‘‘clinical observa-tion at the time of procedure,’’ without other establishedcriteria. Another entry item of concern is pancreatitis before

Copyright ª 2009 by the American Society for Gastrointestinal Endoscopy

0016-5107/$36.00

doi:10.1016/j.gie.2009.01.008

www.giejournal.org

the procedure, because it appears as though acute andchronic pancreatitis were grouped together. Such data be-come of questionable usefulness because of the lack of astrict definition of the condition. In addition, over 12 years,there is a continual enhancement of the database, withadditions, deletions, or alterations of various data fields,and such changes could affect retrospective data analysis.Nevertheless, multivariate analysis of their data presentsus with independent risk factors for the categories ofoverall complications, pancreatitis, bleeding, and severeor fatal complications. Their data of ERCP-related infectionsand antibiotic prophylaxis were reported in an earlierarticle.3

As noted, the overall complication rate was 4%, with 73%of complications being rated as mild and 9% as severe andwith a 2% fatality rate. This low overall complication rateis similar to studies by Loperfido et al4 and Williams et al.5

However, other studies reported higher complicationrates,6 including a review of 21 prospective studies ofERCP-related complications.7 In the study by Cotton et al,1

independent factors that were identified to increase therisk of overall complications included suspected sphincterof Oddi dysfunction (SOD) and the performance of a biliarysphincterotomy. They found that placement of a small-di-ameter pancreatic-duct stent (SDPDS) and the presenceof pancreatitis before the procedure conferred some pro-tection against a procedure-related complication. In regardto the presence of pancreatitis before the ERCP, it is not clearwhat severity or chronicity of the disease was considered.Because both acute and chronic pancreatitis were allowedfor this entry, one could assume that patients with a historyof chronic pancreatitis might have experienced a lower rateof procedure-related pancreatitis. However, this was not ob-served. The group experienced a lower overall complica-tion rate but not a lower rate of pancreatitis, and this isdifficult to explain.

As expected, pancreatitis was the most common compli-cation, which occurred in 2.6% of cases. The study reportsthat patients with suspected SOD had a higher rate of

Risk factors for complications during or afterERCP may be patient, procedure, or operatorrelated.

Volume 70, No. 1 : 2009 GASTROINTESTINAL ENDOSCOPY 89

Page 2: ERCP complication rates: how low can we go?

Editorial Ryan

pancreatitis, a finding noted in earlier studies.5,6,8-10 Place-ment of an SDPDS was shown, in several articles, to lowerthe rate of pancreatitis in patients at high risk for this compli-cation.11-13 The current study confirmed these findings forpatients with SOD; however, SDPDS were apparently notprotective in other high-risk patients in whom stents wereplaced. The analysis did not find that placement of thesestents lowered the rate of pancreatitis in the entire groupof patients who received stents, only in those suspected ofSOD. The reason for this is not apparent from the data pre-sented. In a meta-analysis by Singh et al,13 patients consid-ered to be at high risk for ERCP-induced pancreatitis whodid not receive a prophylactic pancreatic-duct stent were 3times more likely to develop this complication comparedwith those who received a stent. Of the 5 studies involvedin this meta-analysis, 4 studies included suspected SOD aspatients at high risk. Other indications for pancreatic-stentplacement included difficult cannulation, pre-cut sphincter-otomy, and balloon dilation of the ampulla. With the findingsby Cotton et al,1 the question needs to be asked whetherSDPDS are only beneficial in those patients with suspectedSOD and should only be placed in this group. Placementof pancreatic-duct stents often requires additional ductalmanipulation, which could actually increase the risk of pan-creatitis, the risk of duct injury, or pancreatic-stricture forma-tion. It would be of benefit to know if suspected SOD is theonly group that will benefit by prophylactic stents.

Another risk factor identified for the development ofpancreatitis was performance of a pancreatogram that in-volved either the major papilla or the minor papilla. Thestudy did not look at the issues of difficulty of cannulation,repeated injections of contrast, or the degree of opacifica-tion of the pancreatic duct as risk factors, although thesehave been identified as such in other studies.5,6,8-10 It con-tinues to be apparent that pancreatic cannulation is a proce-dure-related risk factor for the development of pancreatitis.It seems reasonable that we should attempt to avoid pancre-atic cannulation and injection, when possible.

There was significant bleeding in 40 patients, and, as onewould expect, the performance of a biliary sphincterotomywas an independent risk factor. Mild coagulopathy was pres-ent in 529 patients in this study, and bleeding developed in 2of these patients. Unfortunately, we do not gain any furtherinsight into the role of anticoagulants or antiplatelet agentsin the development of bleeding. The American Society forGastrointestinal Endoscopy (ASGE) guidelines on the man-agement of anticoagulation and antiplatelet therapy forendoscopic procedures14 indicate that biliary sphincterot-omy can be performed in the presence of aspirin or nonste-roidal anti-inflammatory drug therapy; these data aresupported by Freeman et al.8 The guidelines further recom-mend discontinuation of warfarin 3 to 5 days beforeendoscopic sphincterotomy (ES) and heparin therapy ad-ministered for subtherapeutic international normalizedratio in patients at high risk for thromboembolism. Resump-tion of anticoagulation therapy after sphincterotomy is an

90 GASTROINTESTINAL ENDOSCOPY Volume 70, No. 1 : 2009

area devoid of data. Freeman et al8 showed that clinical rec-ognition of bleeding was delayed from 1 to 10 days in 52% ofpatients who developed bleeding after biliary sphincterot-omy, and resumption of anticoagulation within 3 days ofsphincterotomy was a risk factor for the development ofsuch bleeding. The current standard is to individualize theresumption of anticoagulation based upon the patient’srisk of developing thromboembolic events. We are also lack-ing data regarding the preprocedure and postprocedureuse of newer antiplatelet agents that are either inhibitorsof adenosine diphosphate–induced platelet aggregation(eg, clopidogrel) or those agents that inhibit the glycopro-tein IIb/IIIa receptor (eg, eptifibatide). Given that the lattergroup of drugs are administered intravenously, and arereversible, receptor inhibitors, they are of less-frequent con-cern to us than the former group, which is used orally forchronic prophylaxis of thrombosis. This is an area in whichadditional information regarding the safe use of theseagents in patients undergoing ES would be welcomed.

The study by Cotton et al1 described a group of 42 se-vere and 7 fatal outcomes as a result of ERCP and identi-fied 5 independent risk factors: poor health status,obesity, suspected or known choledocholithiasis, pancre-atic manometry procedures, and complex procedures. Itis understandable that patients in poor health and thoseundergoing complex procedures would fare less wellthan healthier patients or those with procedures regardedas less complex. These results are not surprising. As notedearlier, obesity was determined by individual observationof the patient without other definition. Therefore, thedata regarding obesity as a risk factor for severe or fatalcomplications have to be interpreted with caution. Forthose patients with suspected or known choledocholithia-sis, we would expect that this group would undergo ESand, if needed, more aggressive effort for biliary cannula-tion, eg, pre-cut sphincterotomy. With sphincterotomy be-ing a risk factor for bleeding, it would not be surprisingthat this group would be at an increased risk for severeor fatal complications as a result. The finding of pancreaticmanometry as a risk factor in this group is unexplained.Pancreatic manometry was not an independent risk factorfor pancreatitis or other complications. Other studiesshowed that manometry itself was not a risk factor forpancreatitis.9,10 Why this appears as a risk factor for severecomplications or fatal outcomes is not clear.

Also, this study identified 16 perforations; too few to an-alyze. Another expected finding is that the majority of perfo-rations were of the bowel wall in patients with prior surgicalbiliary diversion procedures. This finding reminds us of ourneed to exercise caution when performing ERCP in patientswith a surgical history.

Where do we go from here? Even with the potential biasof underestimating the rate of delayed complications, it isunlikely that all centers that perform ERCP are going to reachthe low complication rates reported in this study. We muststrive to lower complications by being aware of identified

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Ryan Editorial

risk factors and by attempting to impact those risk factorsthat we can. In this regard, appropriate patient selection isparamount in the reduction of ERCP complications. Diag-nostic ERCP has been replaced in most centers by less-inva-sive procedures. MRCP and EUS were shown to be safe andaccurate alternatives to ERCP for the detection of choledo-cholithiasis or obstruction.15-17 The initial use of these less-invasive modalities to select patients for therapeutic ERCPshould reduce the need for diagnostic ERCP.18

For patients with a low-to-intermediate probability of com-mon bile duct stones, ERCP before cholecystectomy is notnecessary.19,20 However, sphincterotomy and stone removalcontinue to have a role for those preoperative patients inwhom the possibility of choledocholithiasis is likely.19,20

Patients with suspected SOD are at higher risk for ERCP-related complications, especially pancreatitis, and severalstudies showed that placement of an SDPDS can lessenthe risk. The main problem for us remains in the selectionof patients with suspected SOD who will benefit fromERCP intervention. ASGE guidelines for the appropriateuse of GI endoscopy states that ‘‘ERCP is generally not indi-cated in evaluation of abdominal pain of obscure origin inthe absence of objective findings that suggest biliary or pan-creatic disease,’’21 a position supported by Sherman22 andPasricha23 in reviews of the role of ERCP in patients whopresent only with abdominal pain (type III). There doesappear to be a role for ERCP in SOD when evidence of biliaryor pancreatic disease is present (types I and II) and is associ-ated with a greater chance of improvement after endoscopicintervention.22

Performance of ES is a risk factor for the development ofsignificant bleeding and correction of coagulopathy beforeES lowers this risk. Future studies that focus on the appro-priate time interval of discontinuation of anticoagulants andantiplatelet agents before ES as well as their reintroductionto high-risk patients after ES would be of benefit.

There will always be some degree of risk with our inva-sion of the pancreas or biliary tree. The study by Cottonet al1 draws our attention to low complication rates thatcan be achieved with complex therapeutic ERCP. If we at-tempt to modify those risk factors associated with ERCPcomplications, then the question that remains is, how lowcan we go?

DISCLOSURE

The author disclosed no financial relationshipsrelevant to this publication.

Michael E. Ryan, MDDepartment of Gastroenterology

Marshfield ClinicMarshfield, Wisconsin, USA

Abbreviations: ASGE, American Society for Gastrointestinal Endoscopy;

ES, endoscopic sphincterotomy; SDPDS, small-diameter pancreatic-duct

stent; SOD, sphincter of Oddi dysfunction.

www.giejournal.org

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4. Loperfido S, Giampaolo A, Benedetti G, et al. Major early complications

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in suspected choledocholithiasis. Gastrointest Endosc 2008;67:235-44.

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Volume 70, No. 1 : 2009 GASTROINTESTINAL ENDOSCOPY 91