Indications for and Contraindications to ERCP

Indications for and Contraindications to ERCP

An understanding of indications and contraindications for any procedure is part of being a well-trained endoscopist, a fact recognized in the 2002 ASGE guidelines on Methods of Granting Hospital Privileges for Performing Endoscopy. The list of attributes indicating satisfactory training in ERCP included “a thorough understanding of the indications, contraindications, individual risk factors and benefit-risk considerations for the individual patient.” There are very few indications for purely diagnostic ERCP in modern practice. Therefore there is no role for the solely diagnostic ERCP endoscopist. As the technical demands of ERCP have increased, so have the range and complexity of tasks that the ERCP endoscopist is expected to master. All ERCP endoscopists need to know how to perform safe and effective biliary sphincterotomy, remove bile duct stones, dilate biliary strictures, place plastic and expandable metal biliary stents, and provide PEP prophylaxis with small-caliber PD stents. In the “old days,” many ERCP endoscopists avoided pancreatic intervention altogether. However, now that the benefits of PD stenting as prophylaxis against PEP have become clear from multiple published studies, the ability to place a PD stent is a necessary part of the modern ERCP endoscopist's skill set.

The authors of the 2015 ASGE/ACG Taskforce for Quality in Endoscopy publication “Quality Indicators for ERCP” identified the level of confidence of each recommendation based on the available literature ( Box 7.1 ). Laudable as this effort appears, solid evidence was frequently missing in support of what we consider important parts of the preparation for, performance of, and follow-up after ERCP ( Table 7.1 ).

Another way of looking at such evidence is the GRADE system, such as the one that the 2015 ASGE Practice Guideline “The role of ERCP in Benign Diseases of the Biliary Tract” offered: high-quality evidence (4+), moderate-quality evidence (3+), low-quality evidence (2+), and very low-quality evidence (1+) (see also Box 7.1 ).

The ASGE offered the following position statements on ERCP:

• We recommend that diagnostic ERCP not be undertaken for the evaluation of pancreaticobiliary-type pain in the absence of objective abnormalities on other pancreaticobiliary imaging or laboratory studies (3+).

• We recommend that routine ERCP before laparoscopic cholecystectomy not be performed in the absence of objective signs of biliary obstruction or stone (3+).

• We recommend that ERCP in patients with acute biliary pancreatitis be limited to those with concomitant cholangitis or biliary obstruction (4+).

• We recommend ERCP with dilation and stent placement for benign biliary strictures (3+).

• We recommend that ERCP be undertaken as first-line therapy for postoperative biliary leaks (4+).

• We suggest that cholangioscopy be considered as an adjunctive technique for the management of difficult bile duct stones not amenable to removal after sphincterotomy with or without balloon dilation or mechanical lithotripsy (2+).

• We suggest that cholangioscopy with directed biopsy be considered as an adjunctive technique for the characterization of biliary strictures (2+).

• We recommend ERCP with sphincterotomy for patients with type I SOD (3+).

• We recommend against the performance of ERCP for the evaluation or treatment of type III SOD (4+).

• We recommend rectal indomethacin with or without a pancreatic stent for prophylaxis against post-ERCP pancreatitis when ERCP is performed in patients with suspected SOD (3+).

Indications for ERCP

The recommended indications for ERCP in the ASGE/ACG Joint Taskforce document “Quality indicators for ERCP” are listed in Box 7.2 (A through Q). This alphabetic scale is unrelated to the quality of evidence scale (4+, 3+, 2+, and 1+) as just discussed. We added a few miscellaneous indications as an extra category, identified as R. Text added by us to clarify descriptions is in italics.

• A.

  Jaundice thought to be the result of biliary obstruction

  • Comment: ERCP is not always indicated in this setting. Patients who are candidates for resection of tumors causing biliary obstruction may not require preoperative biliary drainage. In the last decade, surgeons have claimed that preoperative ERCP and biliary stenting increase the risk of adverse events of surgery. Some of the most vocal condemnation of endoscopic intervention arose from poorly done retrospective studies. Prospective data confirmed what most biliary and pancreatic surgeons already knew; that is, preoperative biliary drainage increases postoperative infections, presumably because of the introduction of bacteria into a sterile system (the biliary tree) via cannulas and other instruments, but does not increase mortality. Experts now agree that the decision to preoperatively drain the biliary tree in a patient awaiting surgery for malignant jaundice should be made by consensus, with the active involvement of the surgeon, the ERCP endoscopist, and (if available) the interventional radiologist. Patients who are septic with cholangitis (which is rare in malignant jaundice) or have severe pruritus caused by biliary obstruction (despite antipruritic drugs) need their biliary trees drained if there is going to be significant delay in surgery (e.g., for preoperative chemo-irradiation) ; this can be done endoscopically (ERCP) or percutaneously (transhepatically). On the other hand, patients who are asymptomatic and who can be scheduled for their surgery within a week or so of presentation are probably better served by not having drainage. In the authors' experience, many surgeons prefer the convenience of having the biliary tree drained preoperatively and having an anatomic and cytologic (or histologic) diagnosis to discuss with the patient and his or her family. In the “old days,” ERCP in a patient with presumed obstructive jaundice was often a “fishing trip,” as the cause was uncertain. In the era of high-quality cross-sectional imaging such as helical computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), and endoscopic ultrasonography (EUS) (see Chapter 34 ), it is now rare for the diagnosis to be in doubt, although small tumors, small stones, and papillary stenosis continue to present diagnostic difficulty.

• B.

  Clinical and biochemical or imaging data suggestive of pancreatic or biliary tract disease

  • Comment: Previously, minor elevations of liver enzymes or pancreatic enzymes were often used to justify ERCP. Without imaging evidence of biliary obstruction or pancreatitis, the yield of ERCP in these circumstances is low and makes it difficult to justify the potential risks. All patients with sphincter of Oddi dysfunction (SOD) type I and the majority of those with SOD type II should have transient elevation of serologic liver test levels that normalize between episodes. Patients whose liver tests fail to normalize between attacks should not be classified as having SOD. They may have papillary stenosis, some other cause of subtle biliary structuring, or a chronic disorder affecting the liver parenchyma, such as fatty liver (steatosis). Similarly, persistent mild elevation of serum amylase and lipase in the absence of radiologic abnormality is unlikely to reflect pathology that will be revealed by ERCP. However, acute recurrent idiopathic pancreatitis does justify endoscopic imaging (see “D. Pancreatitis of unknown etiology” and Chapter 52 ). If biliary microlithiasis is suspected, EUS is less invasive and more sensitive for this diagnosis. Increasingly, EUS is being used immediately before planned ERCP in low-yield, high-risk settings. If the EUS is negative, the ERCP can be avoided, sparing the patient the risk of a more invasive procedure.

• C.

  Signs or symptoms suggesting pancreatic malignancy when direct imaging results are equivocal or normal

  • Comment: It is difficult to know exactly what was intended here. If there is doubt about the presence or absence of a mass, usually in the head of the pancreas, or the significance of biliary and/or pancreatic ductal dilatation, EUS is probably the investigation of choice, ahead of ERCP. The imaging resolution of EUS is so good that a small stone or subtle stricture is more likely to be identified by EUS than by ERCP.

• D.

  Pancreatitis of unknown etiology

  • Comment: By “pancreatitis,” we believe that “acute pancreatitis” was intended. Patients with idiopathic acute recurrent pancreatitis (IARP) who have an intact gallbladder but have had negative imaging (e.g., transcutaneous ultrasonography, CT, magnetic resonance imaging [MRI]) for cholelithiasis and choledocholithiasis should have EUS to look for biliary sludge (microlithiasis) and small stones. EUS is frequently positive for these findings when repeated imaging by other means has been negative. Any patient with IARP should have inspection of the main duodenal papilla by duodenoscopy with a side-viewing instrument to look for obvious anatomic abnormalities, such as a choledochocele or an ampullary tumor. The anatomic abnormality of pancreas divisum (P. Div.) is now often recognized by MRCP or EUS (i.e., not requiring pancreatography through the minor duodenal papilla). Minor papilla cannulation and contrast injection to confirm the diagnosis of P. Div. should be performed only if therapy (i.e., minor papillotomy) is planned, in the appropriate clinical setting (i.e., IARP without other explanation). If IARP is considered to be caused by pancreatic sphincter dysfunction, ideally the patient should be referred to a center where pancreatic manometry is available to confirm the diagnosis before treatment (i.e., pancreatic sphincterotomy). In current ERCP practice, however, many endoscopists proceed with empiric pancreatic sphincterotomy (usually done over a stent placed in the PD orifice) without prior manometry. Pancreatic sphincterotomy and PD stenting are not entirely benign interventions, risking perforation, PEP, stenosis of the opening, and focal “groove” pancreatitis across the length of the stent (from side branch occlusion). The risks and benefits of empiric pancreatic endotherapy should always be carefully weighed before proceeding.

• E.

  Preoperative evaluation of chronic pancreatitis or pancreatic pseudocyst

  • Comment: The quality of modern CT scanning and MRI is so good that endoscopic retrograde pancreatography (ERP) may have little or nothing to add in the preoperative evaluation of chronic pancreatitis (CP). In addition, EUS allows aspiration for biochemical studies when the diagnosis is in doubt. However, fistulae from the pancreatic duct to adjacent structures or communicating with pseudocysts are still most accurately identified by ERP, when this is deemed necessary. Endoscopic pseudocyst decompression is increasingly being performed by EUS alone. As a result, the opportunity to perform ERP to identify and stent (where possible) a communicating PD fistula during endoscopic pseudocyst drainage is becoming less common and reserved for patients with smaller pseudocysts that are not in optimal locations for EUS-guided drainage. There are no data yet available to indicate whether the lack of a retrograde pancreatogram adversely affects the outcome of EUS-guided pseudocyst decompression.

• F.

  Sphincter of Oddi manometry (SOM) (see Chapter 16 ).

  • Comment: SOM remains one of the few indications for mainly diagnostic ERCP. However, some SOM procedures (i.e., those showing abnormally high pressures) will lead to therapeutic intervention, usually sphincterotomy, and all should include placement of a small-diameter PD stent to preclude or mitigate procedural pancreatitis.

• G.

  Empirical biliary sphincterotomy without sphincter of Oddi manometry is not recommended in patients with suspected type III sphincter of Oddi dysfunction.

  • Comment: The EPISOD trial conducted in 2014 was a 2-arm parallel, randomized, double-blind, sham-controlled, multicenter study that confirmed that SOM and sphincterotomy do not benefit patients with type III SOD and are associated with significant rates of adverse events. Indeed, it is anticipated that this diagnosis will be eliminated as an entity.

• H.

  Endoscopic sphincterotomy (ES)

  • Comment: ES may be used in the primary management of certain conditions, such as papillary stenosis, and to facilitate other therapeutic interventions in the biliary tree.

  • H1.

    Choledocholithiasis

  • Comment: ERCP is used not only for access to recover bile duct stones, but also to access and retrieve stones in the cystic duct and gallbladder and to place nasocystic drains and stents.

  • H2.

    Papillary stenosis or sphincter of Oddi dysfunction (SOD) (see Chapter 47 )

  • Comment: Only symptomatic patients should be investigated and treated.

  • H3.

    Facilitate biliary stent placement or dilation of biliary strictures.

  • Comment: Biliary and pancreatic duct stricture dilation is mentioned elsewhere. Balloon dilation of the biliary sphincter (“biliary sphincteroplasty,” Chapter 18 ) is an alternative to sphincterotomy. However, increasingly the two are being used in combination: a relatively small sphincterotomy is performed, followed by balloon dilation for removal of large stones.

  • H4.

    Sump syndrome

  • Comment: Sump syndrome is increasingly rare, as choledochoduodenostomy has largely been abandoned in favor of hepaticojejunostomy for biliary diversion.

  • H5.

    Choledochocele

  • Comment: Choledochoceles are often incised using a needle-knife papillotome, with the opening being extended as necessary using a standard “pull” papillotome.

  • H6.

    [Decompressing biliary obstruction in] Ampullary carcinoma in poor surgical candidates

  • Comment: Large sphincterotomies intended to open bile ducts obstructed by ampullary tumors carry a significant risk of bleeding. The preferred approach by many endoscopists today is to place a stent across the stenosis rather than perform sphincterotomy in this setting.

  • H7.

    Access to pancreatic duct

  • Comment: Access to the pancreatic duct for contact or mechanical lithotripsy of stones, and their extraction, or pancreatoscopy using miniscopes requires pancreatic sphincterotomy.

• I.

  Stent placement across benign or malignant strictures, fistulae, or postoperative bile leaks, or alongside large nonextractable common bile duct stones

• J.

  Dilation of ductal strictures

• K.

  Balloon dilation of the papilla

• L.

  Nasobiliary (and nasopancreatic) drain placement for acute cholangitis and to lavage pancreatic stone fragments following PD stone lithotripsy, respectively

  • Comment: Nasobiliary drains are uncomfortable for patients, and their placement is an increasingly rare event in modern ERCP practice.

• M.

  Pancreatic pseudocyst drainage in appropriate cases

  • Comment: Increasingly, pancreatic pseudocyst drainage is being performed using EUS alone, especially with the introduction of lumen-apposing, covered, self-expanding metal stents that allow for single-step deployment and the ability to perform endoscopic debridement with minimal stent migration.

• N.

  Tissue sampling from pancreatic or bile ducts

  • Comment: This does not always require endoscopic sphincterotomy, as brushes and other sampling devices can usually be advanced into the duct of interest without enlarging the opening.

• O.

  Ampullectomy of adenomatous neoplasms of the major papilla

• P.

  Pancreatic and biliary therapeutics

  • Comment: To include transpapillary stenting for PD strictures and leaks and removal of PD stones (see Chapters 54 and 55 ).

• Q.

  Facilitation of cholangioscopy and/or pancreatoscopy

  • Comment: Cholangioscopy and pancreatoscopy are important procedures for evaluation of pancreaticobiliary disorders, including indeterminate strictures (see Chapter 41 ) and missed stones during ERCP.

  In addition to the above, we suggest adding the following indications:

• R.

  Access to the bile duct to recover migrated stents, facilitate combined endoscopic-radiologic procedures, investigate (and occasionally treat) hemobilia, and remove parasites (see Chapter 49 ).

Special Cases

ERCP has been shown to be safe and effective in pregnancy (see Chapter 30 ) and in children (see Chapter 29 ), provided that the indications are appropriate and that the necessary precautions are taken (e.g., radiologic shielding of the fetus in pregnancy, sedation modified for use in children).