past, present, and future of endoscopic retrograde cholangiopancreatography: perspectives on the...

Mayo Clin Proc, May 2002, Vol 77 Editorial 407

Mayo Clin Proc. 2002;77:407-412 © 2002 Mayo Foundation for Medical Education and Research

Editorial

Past, Present, and Future of Endoscopic Retrograde Cholangiopancreatography:Perspectives on the National Institutes of Health Consensus Conference

Address reprint requests and correspondence to Todd H. Baron,MD, Division of Gastroenterology and Hepatology, Mayo Clinic, 200First St SW, Rochester, MN 55905 (e-mail: [email protected]).

I n this issue of Mayo Clinic Proceedings, Calvo et al1

examine the diagnostic efficacy of noninvasive magneticresonance cholangiopancreatography (MRCP) in patientswith possible choledocholithiasis. Specifically, the authorsevaluated whether stratifying patients to low, intermediate,or high probability of risk for choledocholithiasis wouldinfluence the value of biliary tree imaging by MRCP com-pared with the more traditional and more widely usedinvasive endoscopic retrograde cholangiopancreatography(ERCP). The importance of this timely topic is underscoredby the recent assembling of a National Institutes of Health(NIH) consensus conference to discuss ERCP and relatedimaging techniques.

The NIH conference was convened in Bethesda, Md,January 14 through 16, 2002. Specialists in gastroenterol-ogy, radiology, surgery, and outcomes research presenteddata to an independent nonfederal panel of practicing clini-cians, biomedical scientists, clinical study methodologists,and a public representative. The goal of the conference wasto review, by using an evidence-based approach, diagnosticand therapeutic ERCP alone and as it relates to other diag-nostic and therapeutic procedures. The following questionswere specifically addressed during the consensus confer-ence: (1) What is the role of ERCP in gallstone disease? (2)What is the role of ERCP in pancreatic and biliary malig-nancy? (3) What is the role of ERCP in pancreatitis? (4)What is the role of ERCP in abdominal pain of possiblepancreatic or biliary origin? (5) What are the factors deter-mining adverse events or success of ERCP? (6) What fu-ture ERCP research directions are needed?

This editorial summarizes the outcome of the NIH con-sensus conference on ERCP and provides perspective as itrelates to the clinical practice of ERCP.

Overview of ERCPEndoscopic retrograde cholangiopancreatography is

both an endoscopic and a radiological procedure performedprimarily by gastroenterologists.2 Endoscopic retrogradecholangiopancreatography is usually performed with use ofconscious sedation: an endoscope is passed to the ampulla(the opening of the bile and pancreatic ducts) located in thesecond portion of the duodenum. For diagnostic studies,

catheters are passed through the channel of the endoscopeinto the duct of interest, and contrast medium is injectedunder fluoroscopic guidance to outline the ductal structuresor to measure sphincter pressure. Therapeutic maneuversmay be performed by incising the sphincter muscle at theopening of the bile duct or pancreatic duct (biliary andpancreatic duct sphincterotomy, respectively). Subse-quently, other accessories may be passed through the endo-scope channel into the duct of interest to remove stones,insert stents, or ablate tissue.

ERCP PastApproximately 30 years ago, ERCP was developed as a

diagnostic modality, primarily to facilitate radiographicimages of the pancreas.3,4 At that time, computed tomogra-phy (CT) was in its infancy. As the technology of bothendoscopes and endoscopic accessories has improved, theprocedure has evolved from a primarily diagnostic modal-ity to a more therapeutic modality. This change has oc-curred as other less invasive pancreaticobiliary imagingmodalities, such as abdominal ultrasonography, CT, mag-netic resonance imaging, MRCP, and endoscopic ultra-sonography (EUS), have emerged and evolved.

ERCP PresentSpecified disease processes and clinical issues as well as

the role of ERCP are discussed subsequently. The consensusof the NIH panel on each of these issues is also presented.

See also page 422.

Gallstones.—Gallstone disease (cholelithiasis) is com-mon. Gallstones within the common bile duct, or choledo-cholithiasis, may be diagnosed and treated with use ofERCP. Choledocholithiasis may be encountered in the pa-tient before and after cholecystectomy. Common bile ductstones may also be encountered intraoperatively at the timeof cholecystectomy. In the patient with an intact gallblad-der, common bile duct stones may be removed preopera-tively with ERCP and sphincterotomy or operatively at thetime of cholecystectomy with bile duct exploration. Post-operatively, ERCP is the preferred method for removingbile duct stones. Standard transabdominal ultrasonographyand abdominal CT scanning have modest sensitivities andspecificities for diagnosing choledocholithiasis. Becauseof its high sensitivity for detecting choledocholithiasis and

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Editorial Mayo Clin Proc, May 2002, Vol 77408

its ability to remove stones at the same time, ERCP isoften the first modality chosen in a patient with suspectedcholedocholithiasis. However, ERCP is invasive and hasassociated risks, including pancreatitis and perforation.5

Recently, MRCP6,7 and EUS8,9 emerged as noninvasiveimaging modalities with a high accuracy for diagnosingcholedocholithiasis. Recommendations from the NIH con-sensus conference panel are that noninvasive imaging stud-ies of the bile duct should be performed when there is a lowindex of clinical suspicion for choledocholithiasis. Endo-scopic retrograde cholangiopancreatography should bereserved for patients in whom choledocholithiasis (eg,clinical cholangitis) is highly suspected10 or used whenother imaging modalities suggest choledocholithiasis.When possible, choledocholithiasis detected at the time ofintraoperative cholangiography during laparoscopic chole-cystectomy should be managed by laparoscopic bile ductexploration.

The report by Calvo et al offers additional support forselective use of noninvasive imaging modalities to sup-plant ERCP. These authors used clinical criteria to predictthe presence of choledocholithiasis and stratified patientsinto 1 of 3 groups: high, intermediate, and low probability.All patients subsequently underwent both ERCP andMRCP. None of the patients stratified to low probability forhaving common bile duct stones had evidence of choled-ocholithiasis on ERCP. Choledocholithiasis was detectedon ERCP in approximately two thirds of patients with highprobability and one third of patients with low probability ofhaving choledocholithiasis. Findings on MRCP correlatedwell with findings on ERCP. The authors concluded thatpatients with low or intermediate risk of choledocholithi-asis can avoid diagnostic ERCP by undergoing MRCP, ashas been suggested in other studies.6,7 Although the radi-ologists who interpreted the MRCP findings in the study byCalvo et al were not blinded to clinical and routine transab-dominal ultrasound findings, their report nevertheless sup-ports the growing body of literature advocating the use ofMRCP as a noninvasive test to avoid a potentially danger-ous and unhelpful diagnostic ERCP.

Malignancies. Ampullary Carcinoma.—Ampullarymalignancies may be diagnosed readily with ERCP sincethey may be visible endoscopically and are amenable tobiopsy with high accuracy. The NIH conference panelconcluded that ERCP is the best modality for diagnosingampullary carcinoma.

Pancreaticobiliary Malignancies.—The consensus con-ference did not distinguish between primary pancreatic andprimary biliary malignancies. Clinically, this may be im-portant, and therefore these are addressed separately.

Although ERCP has been used to diagnose pancreaticcarcinoma,11 more recent noninvasive imaging modalities

have limited its use in this regard. The radiographic diagno-sis of pancreatic carcinoma by ERCP is sensitive but non-specific. A definitive tissue diagnosis of malignancy maybe made at the time of ERCP by using brush cytology, fine-needle aspiration, and biopsy but with a relatively lowyield12 unless several techniques are used at the sametime.13 Abdominal CT, magnetic resonance imaging,MRCP, and EUS have good accuracy in the radiographicdiagnosis and staging of pancreatic cancer.14-16 Also, EUSfacilitates tissue sampling and staging for potential opera-tive resection.17 Therefore, almost no role exists for usingERCP as a purely diagnostic modality for pancreatic carci-noma. Most patients with pancreatic carcinoma presentwith obstructive jaundice. During ERCP, stents may beplaced in the common bile duct to relieve biliary obstruc-tion.18 Because evidence is insufficient that preoperativedecompression of the biliary tree improves the outcome ofpatients with pancreatic cancer,19 those with surgically re-sectable disease based on other imaging studies are bestmanaged by attempted operative resection without ERCP.In patients with unresectable disease, ERCP with stentplacement is best reserved for palliation of obstructivejaundice.

Randomized studies20 comparing surgical palliation ofobstructive jaundice with ERCP-placed plastic stents showa better short-term outcome with ERCP with a lower mor-bidity and mortality but with more frequent reinterventionfor recurrent biliary obstruction. In randomized prospec-tive trials,21 expandable metal biliary stents remain patentsignificantly longer than plastic stents, reducing the needfor reintervention for recurrent jaundice due to stent occlu-sion. No randomized trials have compared expandablemetal biliary stent placement and surgery for palliation ofobstructive jaundice in patients with pancreatic carcinoma.It is acknowledged that in clinical practice some patientsmay undergo ERCP preoperatively to relieve intractablepruritus while awaiting operative intervention. In sum-mary, the NIH panel recommended that ERCP be avoidedas a diagnostic or preoperative modality in patients withpotentially resectable pancreatic carcinoma and be used asa nonoperative palliative modality for relief of malignantbiliary obstruction.

Cholangiocarcinoma is a relatively uncommon neo-plasm.22 Many of the issues discussed for patients withpancreatic carcinoma apply to those with cholangio-carcinoma. One major difference is that cholangio-carcinomas frequently involve the bifurcation of the rightand left hepatic ducts and the more proximal biliary tree.Thus, ERCP before consideration of operative resectionmay be hazardous because forceful injection of radio-graphic contrast material into multiple biliary strictures isneeded to assess the biliary anatomy for potential operative



resection. These biliary segments may not be technicallydrainable endoscopically, and the undrained radiographiccontrast promotes cholangitis because ERCP is not a sterileprocedure and bacteria are introduced during the proce-dure.23 Although not separately addressed by the consensuspanel, it is recommended that such patients not undergoroutine ERCP to determine operative resectability butrather should undergo EUS, CT, or MRCP.24 In nonoperativepatients, ERCP and stent placement can be used to palliateobstructive jaundice by selective contrast injection to mini-mize the risk of cholangitis.25

Treatment of Pancreatitis. Acute Biliary Pancreati-tis.—Gallstones that pass into the common bile duct andampulla account for biliary pancreatitis, the most commoncause of acute pancreatitis. The offending stone has oftenpassed out of the bile duct by the time the patient clinicallypresents with pancreatitis. The role of ERCP in such pa-tients is to remove residual bile duct stone(s) and promoteclinical improvement of pancreatitis. Data from random-ized prospective trials26-28 of patients with acute biliarypancreatitis undergoing early ERCP and sphincterotomy (ifbile duct stones are present) vs conservative care show areduction in morbidity and mortality in those with clini-cally severe pancreatitis who undergo early ERCP. There-fore, the NIH panel suggested that early ERCP be used inthe setting of acute pancreatitis only in patients with clini-cally severe gallstone pancreatitis and suspected ongoingbiliary obstruction.

Acute Recurrent Pancreatitis.—Patients with “idio-pathic” or unexplained acute recurrent pancreatitis afterroutine clinical, laboratory, and imaging evaluation mayundergo ERCP in anticipation of endoscopically diagnos-able and treatable conditions, such as pancreas divisum anddysfunction of the sphincter of Oddi. The latter is diag-nosed by manometric catheters passed through the pancre-atic and biliary sphincters. Data from several studies29,30 areweak but suggest that patients with pancreas divisum havea reduction in episodes of acute recurrent pancreatitis, needfor hospitalization, and pain after endoscopic sphincterot-omy of the minor pancreatic papilla. The data suggestingbenefit from severing of the pancreatic and biliary sphincterof Oddi at the major papilla for sphincter of Oddi dysfunc-tion–induced hypertension are inconclusive. Therefore, theNIH panel cautiously recommended ERCP and sphincter-otomy of the minor papilla in patients with idiopathic acuterecurrent pancreatitis and pancreas divisum but realizes thatfurther studies are needed to validate this approach. Endo-scopic retrograde cholangiopancreatography with sphincterof Oddi manometry (SOM) can be considered for patientswith unexplained acute recurrent pancreatitis, but ERCPwithout concomitant SOM has no role, with the possibleexception of when pancreas divisum is being considered.

Severe Necrotizing Pancreatitis.—Many patients withsevere acute pancreatitis, regardless of etiology, have dis-ruptions of the main pancreatic duct. Preliminary datashow that endoscopic placement of a stent within the mainpancreatic duct may result in clinical improvement in asubset of patients whose clinical course of pancreatitis isnot improving.31 At present, the NIH consensus panel be-lieves there is insufficient evidence to support this ap-proach before validation in prospective randomized trials.

Chronic Pancreatitis.—Patients with documentedchronic pancreatitis may have intractable abdominal paindue to a poorly draining pancreatic duct from underlyingbenign pancreatic duct strictures and/or pancreatic ductstones. Traditional management of these patients has beensurgical. With use of ERCP, endoscopic relief of obstruc-tion is technically feasible by balloon dilation of dominantstrictures, placement of stents, and removal of pancreaticduct stones, with or without assistance of extracorporealshock wave lithotripsy.32-36 The NIH consensus panelthought that, although data suggest efficacy with endo-scopic treatment of chronic pancreatitis, studies are neededto compare endoscopic treatment of chronic pancreatitis totraditional surgical and nonsurgical therapies.

Pancreatic Fluid Collections.—Although endoscopicdrainage of various pancreatic fluid collections (pseudo-cysts, abscesses, pancreatic necrosis), especially pancreaticpseudocysts,37-41 is technically feasible with reported out-comes similar to surgery, there are no comparative studiesof endoscopic drainage and surgery or percutaneoustherapy. The NIH consensus panel recommended random-ized prospective trials be performed that compare endo-scopic, surgical, and percutaneous therapy for pseudocystdrainage.

Abdominal Pain of Possible Pancreatic or BiliaryOrigin.—Patients who present with unexplained abdomi-nal pain and normal findings on diagnostic, noninvasivestudies and (frequently) prior cholecystectomy remain diffi-cult to manage. In some such patients, diagnostic ERCP withSOM can diagnose and treat possible underlying dysfunc-tion of the sphincter of Oddi. Patients may be classifiedclinically by objective criteria before ERCP is performed.42

A subset of patients who present with some documentedobjective evidence of either abnormal liver enzymes duringan attack or an abnormally dilated bile duct on noninvasiveimaging studies appear to benefit from SOM, followed byendoscopic biliary sphincterotomy if abnormally highsphincter pressures are identified.43 Patients with abdomi-nal pain alone with no objective clinical or radiographicfindings of biliary disease do not appear to benefit fromthis approach and may have visceral hyperalgesia.44 TheNIH panel recommended selective use of SOM in patientswith some objective findings of delayed biliary drainage.



Patients with multiple objective findings of poor biliarydrainage benefit from endoscopic biliary sphincterotomywithout need for manometry.45 The panel emphasized thatpatients with unexplained abdominal pain but no objectivefindings should not undergo a diagnostic ERCP alone(without manometry) because there is little likelihood thesepatients will benefit, and severe complications are likely tooccur.

Adverse Events or Success.—Several serious compli-cations may occur as a result of diagnostic or therapeuticERCP. These complications include pancreatitis, bleeding,infection, perforation, and problems with sedation5 andmay result in death. The literature suggests that risk factorsfor complications after ERCP are patient related, procedurerelated, and operator related.46 The main patient-relatedrisk factors for an adverse outcome after ERCP are under-lying coagulopathy and suspected dysfunction of thesphincter of Oddi. The highest complication rates are inpatients who will least likely benefit from the proce-dure.47,48 Procedure-related complications include difficultbile duct cannulation, injection of radiographic contrastmaterial into the pancreatic duct, and precut biliary sphinc-terotomy.46,47 Low ERCP caseloads have been found to bean endoscopist-related risk factor for higher post-ERCPcomplications and lower success rates.46,47 Finally, atsmaller medical centers in which fewer than 200 ERCPsper year are performed, post-ERCP complications are arisk.49 The NIH panel strongly recommended that onlyphysicians with adequate training and experience shouldperform ERCP (training guidelines described subse-quently). Further studies are needed to determine factorsresponsible for ERCP-induced pancreatitis and whethermedical therapy administered to high-risk patients will re-duce the risk of post-ERCP complications.

Miscellaneous.—A diagnostic ERCP issue not specifi-cally addressed by the panel is using ERCP for diagnosingprimary sclerosing cholangitis. Although ERCP remainsthe gold standard for this diagnosis, MRCP may be a usefulalternative.50 Additionally, although ERCP may also beuseful for diagnosing intraductal papillary mucinous tu-mors of the pancreas by the endoscopic finding of mucinexiting the pancreatic duct,51 its role compared withMRCP52 and EUS53 has not been defined. Finally, therapeu-tic applications of ERCP in which its efficacy has beenproved but were not discussed by the panel include endo-scopic treatment of bile duct leaks after cholecystectomy,54

benign biliary strictures,55 and postorthotopic liver trans-plantation bile duct diseases.56

ERCP FutureThe consensus panel made some clear-cut recommenda-

tions. The most important was the need for improvement in

the quality of clinical trials involving ERCP in the manage-ment of pancreaticobiliary disorders. The panel was unifiedand strong in its belief that this need could be met byinitiating a cooperative group mechanism with the devel-opment of an infrastructure for multicenter participation inthe design of high-quality clinical trials. This would requireNIH funding. A blueprint for this action is in the OncologyCooperative Studies, which the NIH supports.

The panel recognized that ERCP has evolved to a pre-dominantly therapeutic procedure. The article by Calvo etal shows the efficacy of MRCP for improving the diagnosisof choledocholithiasis, and the advances in other technolo-gies that are less invasive than ERCP allow them to be usedinitially for diagnostic purposes and for ERCP to be usedfor therapeutic purposes. An important distinction betweenERCP and other modalities is that it has both diagnosticand therapeutic potential.

Endoscopic retrograde cholangiopancreatographyshould be performed by endoscopists with appropriatetraining and expertise. This issue is extremely importantbecause patient safety and outcome are affected. Anotherimportant issue concerns training physicians to performERCP and what methods should be used. Data regardingtraining for ERCP are limited, but studies57 show that gas-troenterology fellows achieved overall competence aftercompleting 180 to 200 ERCPs. Controversy exists overwhether a certain number of “cases performed” is a goodindex for determining who should perform ERCP (andother procedures), but it is a factor. The American Societyfor Gastrointestinal Endoscopy58 previously recommendedthe minimum number of ERCPs that should be performedbefore competency can be assessed (not granted) is 100cases, of which at least 25 were therapeutic (including 20sphincterotomies and 5 stent placements). The AmericanSociety for Gastrointestinal Endoscopy recently revised itsrecommendations and now suggests that the minimumnumber of procedures before ERCP competency can beassessed is 200, of which 50 are therapeutic (M. B.Kimmey, MD, oral communication, April 2002). Theseissues are similar to those regarding the training of sur-geons to perform laparoscopic bile duct exploration andstone extraction. The NIH panel discussed the use of simu-lators59,60 and other training guides and thought that theirapplication would be important.

The panel recommended future research in the follow-ing areas: (1) role of therapeutic ERCP in the managementof chronic pancreatitis compared with traditional surgicalmanagement, (2) role of ERCP and pancreatic duct stentplacement in patients with acute necrotizing pancreatitis,(3) causes of unexplained acute recurrent pancreatitis andthe role of endoscopic therapy, and (4) clinical importance,natural history, and management of microlithiasis or “bil-



iary sludge.” The time is ripe for high-quality studies toshow clearly the role of ERCP as a therapeutic alternativeto medical, surgical, and percutaneous modalities.

Todd H. Baron, MDMayo ClinicRochester, Minn

David E. Fleischer, MDMayo ClinicScottsdale, Ariz

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