E n d o s c o p i c Ma n a g e m e n t o f B i l i a r y D i s o rd e r s Diagnostic and Therapeutic Todd H. Baron,
MD
KEYWORDS Biliary disorders Endoscopy Endoscopic ultrasound Endoscopic retrograde cholangiopancreatography KEY POINTS Endoscopy allows for diagnostic and therapeutic applications through endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). Because of advancements in abdominal imaging ERCP is now almost an exclusive therapeutic procedure. EUS allows diagnosis by imaging and by tissue acquisition. EUS-guided therapeutics is becoming a viable alternative to percutaneous procedures.
INTRODUCTION
Hirschowitz’s landmark article on fiberoptics1 and subsequent application to flexible endoscopy changed the world of endoscopy. Decades later, the introduction of endoscopic retrograde cholangiopancreatography (ERCP) changed the management of biliary tract disorders.2 ERCP slowly evolved from a purely diagnostic procedure and has matured to become a highly effective therapeutic procedure. Although the indications for diagnostic ERCP are now uncommon, technologic advances have extended its’ diagnostic capabilities beyond simple cholangiography (Box 1). Similarly, endoscopic ultrasound (EUS), a less-invasive diagnostic tool than ERCP, has therapeutic capabilities that have only recently become realized (Box 2). Although ERCP has matured and its’ growth plateaued, there continues to be enormous growth potential for therapeutic EUS. In this article the diagnostic and therapeutic applications of endoscopic techniques for patients with biliary disorders are discussed.
Funding Source: None. Division of Gastroenterology and Hepatology, University of North Carolina, 41041 Bioinformatics Boulevard, CB 7080, Chapel Hill, NC 27599-0001, USA E-mail address: [email protected] Surg Clin N Am 94 (2014) 395–411 http://dx.doi.org/10.1016/j.suc.2013.12.005 surgical.theclinics.com 0039-6109/14/$ – see front matter Ó 2014 Elsevier Inc. All rights reserved.
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Box 1 Applications of ERCP for biliary disease Diagnostic Primary sclerosing cholangitis Indeterminate biliary strictures Sphincter of Oddi manometry Therapeutic Common bile duct stones Bile duct leaks Benign biliary strictures Malignant biliary strictures Transpapillary gallbladder drainage Ampullary adenoma
DIAGNOSTIC ERCP
Diagnostic ERCP has been replaced by noninvasive imaging modalities, such as magnetic resonance imaging (MRI) and magnetic resonance cholangiopancreatography (MRCP), and less-invasive EUS. However, there are several indications for diagnostic ERCP (see Box 1).
Box 2 Applications of EUS for biliary disease Diagnostic Gallbladder Stones Sludge Microlithiasis Bile duct stones Indeterminate biliary strictures Ampullary lesions Therapeutic Transmural gallbladder drainage Transgastric drainage of bilomas Transgastric drainage of hepatic abscesses Biliary drainage Rendezvous Hepaticogastrostomy Choledochoduodenostomy
Endoscopy and Biliary Disorders
Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a fibrosing disease of the biliary tree. The diagnosis rests on clinical features, liver biopsy, and cholangiography. ERCP remains the gold standard for cholangiography, although it has largely been replaced by MRCP.3 ERCP is warranted when MRCP is nondiagnostic or normal when the diagnosis is highly suspected and when cytologic sampling and therapeutic intervention are needed. However, it is important that proper techniques are used to obtain optimal cholangiographic images.4 Complete filling of the intrahepatics is essential to establish the diagnosis in early stages and best obtained when an occlusion balloon catheter (stone retrieval balloon) is positioned above the cystic duct takeoff when the gallbladder is intact (Fig. 1). Patients with PSC are at increased risk for cholangiocarcinoma (CCA). Thus, ERCP is useful for obtaining cytologic and biopsy samples in patients with PSC undergoing ERCP in the presence of dominant strictures and/or a worsening in clinical course. Cytologic evaluation using fluorescent in situ hybridization analysis has proved to be useful in identifying underlying CCA,5 which in turn may allow transplantation6 and improvement in survival. Indeterminate Biliary Strictures
An indeterminate biliary stricture is defined as one that has defied diagnosis despite serum laboratory examination, imaging studies, and histologic sampling. Repeat ERCP with cholangioscopy can be useful in visualizing the stricture and allowing directed biopsies to allow a diagnosis to be established.7 It must be emphasized that cholangioscopy in the setting of PSC is less reliable than in those patients with de novo strictures, because the endoscopic appearance of benign strictures and malignant strictures can be similar.8 There are two methods of cholangioscopy: passage of a cholangioscope through the working channel of the ERCP scope (Fig. 2); and
Fig. 1. Diagnostic cholangiogram for primary sclerosing cholangitis. Note occlusion balloon is inflated below cystic duct take off to maximize contrast filling of the intrahepatic ducts.
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Fig. 2. Cholangioscopy using a prototype video cholangioscope. (A) Radiographic image showing the cholangioscope passed to the bifurcation. A biopsy forceps is seen extending from the cholangioscope. (B) Cholangioscopic image (right) of stricture. Note inset from of the endoscopic image from the ERCP scope shows the cholangioscope in the duodenum entering the papilla.
passage of a small-caliber forward-viewing endoscope (4.9 mm) directly into the bile duct.9,10 The latter is referred to as direct peroral cholangioscopy11,12 and can be technically challenging because the mechanics and angulation do not easily permit a forward-viewing endoscope to be passed directly into the bile duct. However, the optics achieved with these forward-viewing endoscopes are superior (video rather than fiberoptic) and the endoscope has a larger working channel than do cholangioscopes passed through the ERCP channel. Another, recently introduced technologic advancement is the use of probe-based confocal laser endomicroscopy. The probe is passed into the bile duct through the endoscope and allows real-time histologic images of the biliary epithelium. It has shown promise for determining malignancy in patients with and without PSC.13,14 Sphincter of Oddi Manometry
Postcholecystectomy biliary-type pain may be a manifestation of sphincter of Oddi dysfunction (SOD).15 SOD is classified clinically as type I, II, or III. Type I SOD patients have elevated liver tests during an attack that normalize between attacks and a dilated bile duct by imaging. Type II SOD patients have either abnormal liver tests during an attack or a dilated bile duct, but not both. Type III SOD patients have pain only and no objective pancreaticobiliary laboratory or imaging abnormalities. Type I SOD patients respond uniformly to endoscopic sphincterotomy (ES) and manometry is not needed for diagnosis or therapy. Elevated biliary pressures found during SOD manometry at the time of ERCP can predict response to ES in patients with type II SOD.15 The data to support the use of SOD manometry in patients with type III SOD are lacking,15,16 but is offered for those patients who have disabling pain and who understand the risks of potentially fatal and/or disabling adverse effects. THERAPEUTIC ERCP
The most common therapeutic uses of ERCP are the management of common bile duct (CBD) stones and relief of malignant obstruction. However, the range of therapeutic options for biliary disease has exploded (see Box 1).
Endoscopy and Biliary Disorders
CBD Stones
The success rate of ERCP for removal and clearance of CBD stones less than 1.5 cm in the absence of underlying strictures, using ES, balloons, and/or baskets, is nearly 100% when performed by experienced endoscopists. The need for mechanical lithotripsy or intraductal therapy (laser and electrohydraulic lithotripsy) for extraction of large bile duct stones has become less common with the use of combined ES and large-diameter balloon dilation17,18 (12 mm and up to 20 mm) (Fig. 3). This combination enlarges the lumen of the distal bile duct and sphincterotomy opening, the major limitations to successful extraction of large stones. The use of endoscopic balloon dilation alone to extract stones as an alternative to ES has fallen out of favor in the United States because of the higher risk of post-ERCP pancreatitis.19 However, it is useful for selected patients with smaller stones who are at high risk of bleeding (coagulopathy, thrombocytopenia, antithrombotic agents), and perforation (Billroth II anatomy). Benign Biliary Strictures
There are a variety of causes of benign biliary strictures (BBS). Endoscopic therapy for most BBS consists of balloon dilation and placement of plastic biliary stents.20,21 It has
Fig. 3. Combined endoscopic sphincterotomy and large diameter balloon dilation for removal of large bile duct stone. (A) Cholangiogram shows large filling defect. (B) Endoscopic view of 15-mm balloon inflated across sphincterotomy site. (C) Large stone extracted and in the duodenum.
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been shown that placement of multiple side-by-side plastic stents (Fig. 4) that remain in place for 6 to 12 months provides the best results and avoids surgery in more than 90% of patients. Recurrences can be retreated with more aggressive and longerduration stent placement. The use of fully covered self-expandable metal stents (SEMS), which reach diameters up to three times that of rigid plastic stents, has shown
Fig. 4. Endoscopic treatment of an anastomotic biliary stricture after liver transplantation. (A) Initial cholangiogram demonstrates anastomotic stricture. (B) After balloon dilation placement of multiple plastic stents are seen across the stricture. (C) Final cholangiogram at the time of stent removal shows resolution of stricture.
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promise in the treatment of BBS not involving the bifurcation,20 although they are expensive and not approved in the United States for use in benign disease. Bile Duct Leaks
Nearly all bile leaks are postsurgical and occur after biliary surgery, usually cholecystectomy. Leaks are maintained by the high-pressure biliary sphincter. Ablation of the pressure gradient is achieved by endoscopic biliary sphincterotomy, placement of short length biliary stents,22 or a combination of the two (Fig. 5). Placement of a biliary stent across the leak site is generally only necessary when the leak site involves the main duct or biliary anastomosis. As in the treatment of BBS fully covered metal stents can be effective, but are not approved for such treatment and if used should be reserved for cases refractory to standard endoscopic therapy.22,23 Transpapillary Gallbladder Drainage
Transpapillary gallbladder drainage is achieved by ERCP after cannulation and passage of a guidewire across the cystic duct into the gallbladder. A plastic stent is placed with one end in the gallbladder lumen and the other in the duodenum (Fig. 6).24 In some cases of severe cholecystitis a nasocholecystic tube is initially placed and later exchanged to an internal transpapillary stent. The success rate for placement is high in centers with experience in advanced endoscopy. The procedure can be completed without performing an ES in patients with high risk of bleeding and is especially useful when percutaneous drainage fails or is not feasible.25 Ampullary Adenoma
Ampullary adenomas are being increasingly discovered incidentally during endoscopy performed for other reasons. Although the term endoscopic ampullectomy is typically used, the anatomically correct term is endoscopic papillectomy.26 Complete endoscopic resection is feasible even for large lesions (Fig. 7). The main
Fig. 5. Treatment of a postsurgical bile leak. (A) Cholangiogram shows extravasation of contrast. A 10F catheter transpapillary biliary stent was placed across the leak site. (B) Follow-up cholangiogram after stent removal shows absence of leak, but with mild stricture.
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Fig. 6. Endoscopic transpapillary drainage of nonoperative drainage of cholecystitis in a 91-year-old nonoperative patient. (A) Cholangiogram showing guidewire passed into gallbladder passed across obstructing stone in the neck of the gallbladder and cystic duct. (B) Radiographic image with stent placed into gallbladder neck beyond the stone.
Fig. 7. Endoscopic papillectomy. (A) Endoscopic appearance of large periampullary lesion. (B) Gross picture of lesion after endoscopic resection. (C) Endoscopic appearance of resection site.
Endoscopy and Biliary Disorders
limitation to eradication is intraductal extension greater than 1 cm. The presence of cancer can be anticipated if ulceration, firmness, or spontaneous bleeding is identified at the time of endoscopy and is suspected preprocedurally with a presentation of obstructive jaundice in the absence of underlying choledocholithiasis. Resection techniques are similar to polypectomy in other areas except for the use of a sideviewing endoscope. Prophylactic pancreatic duct stents are placed to prevent post-ERCP pancreatitis. For large polyps, especially those with lateral extensions along the duodenal wall, more than one endoscopic procedure is often necessary for complete eradication. Surveillance endoscopy is necessary with the intervals based on histopathology and presence of residual disease on initial follow-up endoscopy.27 Malignant Biliary Obstruction Distal (nonhilar) malignant obstruction
Malignant distal biliary obstruction is effectively treated using a single stent. Obstruction is relieved as effectively as surgical biliary bypass with lower morbidity and mortality, although with an increased rate of reobstruction when 10F catheter plastic stents are used.28 These 10F catheter stents are fixed and are the largest that are passed through a standard therapeutic channel endoscope. Because of the threefold increase in final diameter biliary SEMS have significantly longer patency durations than 10F catheter plastic stents and decrease the need for reintervention when used for palliation of malignant distal obstructive jaundice (Fig. 8). They are also costeffective when used for patients who survive more than 3 to 4 months.28 The first available biliary SEMS were bare metal; later covered SEMS were introduced to reduce tumor ingrowth through the stent spaces (interstices) and potentially prolong patency. The superior patency of covered SEMS remains unproven with contrasting results seen between two meta-analyses.29,30 Advantages of covered SEMS are removability and ease of revision compared with uncovered SEMS, which become imbedded into the surrounding bile duct. Removability may become of upmost importance in patients in whom a tissue diagnosis was not confirmed at the time of placement and who are later found to have benign disease (eg, autoimmune pancreatitis) or curable malignancy (eg, lymphoma31). In patients undergoing biliary stent placement for preoperative decompression, plastic stents are generally used.32,33 SEMS are useful for those patients who will have delay in surgery, such as those patients with pancreatic cancer undergoing neoadjuvant therapy.33,34 Short-length uncovered (nonremovable) SEMS do not preclude subsequent pancreaticoduodenectomy.34 Hilar malignant obstruction
The approach to hilar biliary obstruction is much less straightforward than for distal obstruction28,35 and may be more likely to require percutaneous drainage, depending on endoscopist expertise. Factors that determine unilateral versus bilateral stent placement for palliation of hilar obstruction include potential resectability, Bismuth classification, presence and location of liver atrophy, intrahepatic tumor burden (Fig. 9), and presence of PSC.36 Hilar cases are technically challenging for a variety of reasons. Avoidance of widespread contrast injection is essential to minimize contamination of intrahepatic ducts, and thereby minimize cholangitis resulting from a contaminated, undrained system. Thus, to avoid contrast injection guidewires are passed into intrahepatic ducts without contrast injection using an image-guided approach (computed tomography, MRI). The advantages of SEMS placement are not as clear-cut as for nonhilar obstruction, and reintervention for management of
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Fig. 8. Endoscopic palliation of a distal malignant biliary stricture caused by metastatic breast cancer. (A) Cholangiogram shows long distal bile duct stricture involving the cystic duct take off. Note dilated cystic duct. (B) Radiograph immediately after covered selfexpandable metal stent placement. (C) Endoscopic photo of stent exiting the papilla.
stent occlusion when bilateral stents are placed is often difficult.28 In patients who have SEMS placed for palliation of more advanced hilar CCA there is a greater need for reintervention because of stent occlusion.37 Therapies that can be delivered endoscopically for hilar CCA to prolong palliation include photodynamic therapy38 and, more recently, radiofrequency ablation.39 The use of endoscopically delivered brachytherapy, either low- or high-dose, is now reserved predominately for protocols that allow subsequent liver transplantation.6,40 Therapeutic ERCP in Patients with Surgically Altered Anatomy
ERCP was once considered impossible in patients with altered surgically anatomy. Initially, patients with Billroth II anatomy and biliary disease were successfully approached. With increasing experience, initially using colonoscopes,41 followed by advances in endoscopic technology, particularly balloon enteroscopy, endoscopic biliary therapy can be achieved in patients with post-Whipple anatomy and patients
Endoscopy and Biliary Disorders
Fig. 9. Palliation of malignant hilar obstruction with unilateral metal stent. (A) MRI shows extensive tumor into right system. A dilated left duct can be seen. (B) Access into left system with avoidance of extensive contrast into right system. (C) Placement of uncovered expandable metal stent across stricture into left system proximally and bile duct distally.
with Roux-en-Y anastomoses with high success rates in centers with experience (Fig. 10).42 Unfortunately, biliary cannulation is technically difficult in patients with native papillae because colonoscopes and balloon enteroscopes are forward-viewing rather than side-viewing. ERCP can be performed in patients with Roux-en-Y gastric bypass using a laparoscopic-assisted approach that allows access to the excluded stomach and antegrade passage of a standard side-viewing duodenoscope into the duodenum.43 Novel Percutaneous-Endoscopic Access Approaches
Novel percutaneous-endoscopic access approaches have recently been described to treat biliary diseases.44 Recently termed “percutaneous assisted translumenal endoscopic therapy”45 has been used to treat gallbladder disease and to access the excluded stomach to pass antegrade duodenoscopes in patients with Roux-en-Y gastric bypass anatomy such that management of CBD stones can be achieved entirely endoscopically.46 ENDOSCOPIC ULTRASOUND Diagnostic EUS
EUS has now become a standard part of biliary diagnostics because it is less-invasive than ERCP. EUS is extremely sensitive for the diagnosis of gallbladder sludge, cholelithiasis, and microlithiasis and can establish these diagnoses in patients with
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Fig. 10. Endoscopic treatment of a choledochojejunal (CJ) anastomotic stricture after pylorus-sparing Whipple. (A) Radiographic image on reaching the CJ using a single balloon enteroscope. (B) Cholangiogram showing focal narrowing of CJ. (C) Balloon dilation of CJ stricture yielded excellent result.
suspected biliary pancreatitis who have negative transabdominal ultrasound studies.47 EUS is also sensitive for the diagnosis of CBD stones and is especially useful for patients with suspected CBD stones in whom other imaging studies (transabdominal ultrasound, MRCP) are nondiagnostic. Linear-array EUS allows directed tissue acquisition using fine-needle aspiration techniques and is helpful in establishing a tissue diagnosis of malignant biliary strictures when other modalities are negative,48 for staging of CCA49 and other biliary malignancies, and to evaluate for the presence of lymph node involvement in patients with malignant biliary strictures. Therapeutic EUS Biliary drainage
Applications of therapeutic EUS for biliary disease are now becoming realized. Although EUS to provide biliary access for ERCP using a rendezvous approach is well-established, direct biliary drainage is now becoming an increasingly used
Endoscopy and Biliary Disorders
approach.50 This is because newer accessories specifically designed to access and drain the biliary tree through fine-needle aspiration wire-guided entry are emerging. This allows reliable and safe drainage accessing intrahepatics ducts through the stomach into the left lobe (hepaticogastrostomy), through the duodenum into the bile duct (choledochoduodenostomy), and by accessing these sites and internalizing drainage through the papilla without a rendezvous approach.51,52 EUS-guided biliary drainage is especially helpful where access to the papilla is not possible because of duodenal obstruction.53 Gallbladder drainage
Transgastric and transduodenal drainage of the gallbladder using EUS guidance is an alternative to percutaneous cholecystostomy in patients with acute cholecystitis54 who are poor operative candidates for cholecystectomy. The main advantage of an EUS approach is avoidance of percutaneous drains, which may be life-long if patients are not operative and/or have underlying malignancies.55 Indeed, gallbladder stone clearance can be achieved endoscopically across such internally created tracts.56 Drainage of liver abscesses
Historically liver abscesses have been performed nonsurgically using percutaneous approaches. Recently, transgastric drainage using EUS-guided transgastric approaches have been described and can be performed when percutaneous therapy fails.57 Drainage of bilomas
Similar to liver abscesses, bilomas are usually drained percutaneously. EUS-guided drainage of bilomas through the stomach is an alternative approach.58 ADVERSE EVENTS
Adverse events (AEs) of ERCP and EUS are well-known and include sedation, bleeding, perforation, pancreatitis, infection, bile leakage, and death.59–61 Risk factors for AEs include operator characteristics, patient risk factors, and degree of invasiveness of the procedure. In patients at high risk for post-ERCP pancreatitis the use of rectally administered indomethacin immediately after the ERCP significantly reduces the risk, as does placement of a temporary pancreatic duct stent.62 Fortunately, most AEs can be managed medically, with repeat endoscopy, and/or by percutaneous means. Several types of perforations may occur after ERCP and most can be managed nonsurgically.63 Improved recognition and closure devices allow nonoperative treatment of lateral wall perforations. However, it is important to have all disciplines available (hospitalists, critical care intensivists, interventional radiologists, and surgeons) to manage patients with AEs. Other ERCP-related AEs include stent migration (proximally or distally). EUS-transmural therapies can result in leakage between the puncture site and the biliary tree, perforation, and bleeding. SUMMARY
Endoscopic therapy for biliary diseases has progressed markedly over the last 30 years and has become a mature field. A wide array of biliary diseases can be treated endoscopically using ERCP, with high success rates and low AE rates in experienced centers. EUS is now established as a diagnostic tool for biliary diseases and is also emerging as a therapeutic tool for biliary diseases. Future advancements in ERCP and EUS are expected.
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a predictor of survival in patients undergoing endoscopic stent placement. Gastrointest Endosc 2010;72(4):736–8. Siddiqui A, Shahid H, Sarkar A, et al. Stage of hilar cholangiocarcinoma predicts recurrence of biliary obstruction in patients with metal stents. Clin Gastroenterol Hepatol 2013;11(9):1169–73. http://dx.doi.org/10.1016/j.cgh.2013.05.035. pii: S1542–3565(13)00873-2. Leggett CL, Gorospe EC, Murad MH, et al. Photodynamic therapy for unresectable cholangiocarcinoma: a comparative effectiveness systematic review and meta-analyses. Photodiagnosis Photodyn Ther 2012;9(3):189–95. Figueroa-Barojas P, Bakhru MR, Habib NA, et al. Safety and efficacy of radiofrequency ablation in the management of unresectable bile duct and pancreatic cancer: a novel palliation technique. J Oncol 2013;2013:910897. Simmons DT, Baron TH, Petersen BT, et al. A novel endoscopic approach to brachytherapy in the management of hilar cholangiocarcinoma. Am J Gastroenterol 2006;101(8):1792–6. Chahal P, Baron TH, Poterucha JJ, et al. Endoscopic retrograde cholangiography in post-orthotopic liver transplant population with Roux-en-Y biliary reconstruction. Liver Transpl 2007;13(8):1168–73. Azeem N, Tabibian JH, Baron TH, et al. Use of a single-balloon enteroscope compared with variable-stiffness colonoscopes for endoscopic retrograde cholangiography in liver transplant patients with Roux-en-Y biliary anastomosis. Gastrointest Endosc 2013;77(4):568–77. Saleem A, Levy MJ, Petersen BT, et al. Laparoscopic assisted ERCP in Roux-en-Y gastric bypass (RYGB) surgery patients. J Gastrointest Surg 2012;16(1):203–8. Abu Dayyeh BK, Baron TH. Development of a hybrid percutaneous-endoscopic approach for the complete clearance of gallstones. Clin Gastroenterol Hepatol 2012;10(8):947–9. Baron TH, Song LM. Percutaneous assisted transprosthetic endoscopic therapy (PATENT): expanding gut access to infinity and beyond! (with video). Gastrointest Endosc 2012;76(3):641–4. Law R, Wong Kee Song LM, Petersen BT, et al. Single-session ERCP in patients with previous Roux-en-Y gastric bypass using percutaneous-assisted transprosthetic endoscopic therapy: a case series. Endoscopy 2013;45(8):671–5. Chan HH, Wang EM, Sun MS, et al. Linear echoendoscope-guided ERCP for the diagnosis of occult common bile duct stones. BMC Gastroenterol 2013; 13:44. Ohshima Y, Yasuda I, Kawakami H, et al. EUS-FNA for suspected malignant biliary strictures after negative endoscopic transpapillary brush cytology and forceps biopsy. J Gastroenterol 2011;46(7):921–8. Levy MJ, Heimbach JK, Gores GJ. Endoscopic ultrasound staging of cholangiocarcinoma. Curr Opin Gastroenterol 2012;28(3):244–52. Sarkaria S, Lee HS, Gaidhane M, et al. Advances in endoscopic ultrasoundguided biliary drainage: a comprehensive review. Gut Liver 2013;7(2):129–36. http://dx.doi.org/10.5009/gnl.2013.7.2.129. Gupta K, Perez-Miranda M, Kahaleh M, et al, InEBD Study Group. Endoscopic ultrasound-assisted bile duct access and drainage: multicenter, long-term analysis of approach, outcomes, and complications of a technique in evolution. J Clin Gastroenterol 2013;48(1):80–7. Kahaleh M, Artifon EL, Perez-Miranda M, et al. Endoscopic ultrasonography guided biliary drainage: summary of consortium meeting, May 7th, 2011, Chicago. World J Gastroenterol 2013;19(9):1372–9.
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53. Khashab MA, Fujii LL, Baron TH, et al. EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos). Gastrointest Endosc 2012;76(1):209–13. 54. Jang JW, Lee SS, Song TJ, et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology 2012;142(4):805–11. 55. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc 2007;65(4):735–7. 56. Kamata K, Kitano M, Kudo M, et al. Endoscopic ultrasound (EUS)-guided transluminal endoscopic removal of gallstones. Endoscopy 2010;42(Suppl 2):E331–2. 57. Noh SH, Park do H, Kim YR, et al. EUS-guided drainage of hepatic abscesses not accessible to percutaneous drainage (with videos). Gastrointest Endosc 2010;71(7):1314–9. 58. Shami VM, Talreja JP, Mahajan A, et al. EUS-guided drainage of bilomas: a new alternative? Gastrointest Endosc 2008;67(1):136–40. 59. Balmadrid B, Kozarek R. Prevention and management of adverse events of endoscopic retrograde cholangiopancreatography. Gastrointest Endosc Clin N Am 2013;23(2):385–403. 60. Glomsaker T, Hoff G, Kvaløy JT, et al, Norwegian Gastronet ERCP Group. Patterns and predictive factors of complications after endoscopic retrograde cholangiopancreatography. Br J Surg 2013;100(3):373–80. 61. ASGE Standards of Practice Committee, Early DS, Acosta RD, Chandrasekhara V, et al. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc 2013;77(6):839–43. 62. Akbar A, Abu Dayyeh BK, Baron TH, et al. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol 2013;11(7):778–83. 63. Baron TH, Wong Kee Song LM, Zielinski MD, et al. A comprehensive approach to the management of acute endoscopic perforations (with videos). Gastrointest Endosc 2012;76(4):838–59.
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KEYWORDS Biliary disorders Endoscopy Endoscopic ultrasound Endoscopic retrograde cholangiopancreatography KEY POINTS Endoscopy allows for diagnostic and therapeutic applications through endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS). Because of advancements in abdominal imaging ERCP is now almost an exclusive therapeutic procedure. EUS allows diagnosis by imaging and by tissue acquisition. EUS-guided therapeutics is becoming a viable alternative to percutaneous procedures.
INTRODUCTION
Hirschowitz’s landmark article on fiberoptics1 and subsequent application to flexible endoscopy changed the world of endoscopy. Decades later, the introduction of endoscopic retrograde cholangiopancreatography (ERCP) changed the management of biliary tract disorders.2 ERCP slowly evolved from a purely diagnostic procedure and has matured to become a highly effective therapeutic procedure. Although the indications for diagnostic ERCP are now uncommon, technologic advances have extended its’ diagnostic capabilities beyond simple cholangiography (Box 1). Similarly, endoscopic ultrasound (EUS), a less-invasive diagnostic tool than ERCP, has therapeutic capabilities that have only recently become realized (Box 2). Although ERCP has matured and its’ growth plateaued, there continues to be enormous growth potential for therapeutic EUS. In this article the diagnostic and therapeutic applications of endoscopic techniques for patients with biliary disorders are discussed.
Funding Source: None. Division of Gastroenterology and Hepatology, University of North Carolina, 41041 Bioinformatics Boulevard, CB 7080, Chapel Hill, NC 27599-0001, USA E-mail address: [email protected] Surg Clin N Am 94 (2014) 395–411 http://dx.doi.org/10.1016/j.suc.2013.12.005 surgical.theclinics.com 0039-6109/14/$ – see front matter Ó 2014 Elsevier Inc. All rights reserved.
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Box 1 Applications of ERCP for biliary disease Diagnostic Primary sclerosing cholangitis Indeterminate biliary strictures Sphincter of Oddi manometry Therapeutic Common bile duct stones Bile duct leaks Benign biliary strictures Malignant biliary strictures Transpapillary gallbladder drainage Ampullary adenoma
DIAGNOSTIC ERCP
Diagnostic ERCP has been replaced by noninvasive imaging modalities, such as magnetic resonance imaging (MRI) and magnetic resonance cholangiopancreatography (MRCP), and less-invasive EUS. However, there are several indications for diagnostic ERCP (see Box 1).
Box 2 Applications of EUS for biliary disease Diagnostic Gallbladder Stones Sludge Microlithiasis Bile duct stones Indeterminate biliary strictures Ampullary lesions Therapeutic Transmural gallbladder drainage Transgastric drainage of bilomas Transgastric drainage of hepatic abscesses Biliary drainage Rendezvous Hepaticogastrostomy Choledochoduodenostomy
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Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC) is a fibrosing disease of the biliary tree. The diagnosis rests on clinical features, liver biopsy, and cholangiography. ERCP remains the gold standard for cholangiography, although it has largely been replaced by MRCP.3 ERCP is warranted when MRCP is nondiagnostic or normal when the diagnosis is highly suspected and when cytologic sampling and therapeutic intervention are needed. However, it is important that proper techniques are used to obtain optimal cholangiographic images.4 Complete filling of the intrahepatics is essential to establish the diagnosis in early stages and best obtained when an occlusion balloon catheter (stone retrieval balloon) is positioned above the cystic duct takeoff when the gallbladder is intact (Fig. 1). Patients with PSC are at increased risk for cholangiocarcinoma (CCA). Thus, ERCP is useful for obtaining cytologic and biopsy samples in patients with PSC undergoing ERCP in the presence of dominant strictures and/or a worsening in clinical course. Cytologic evaluation using fluorescent in situ hybridization analysis has proved to be useful in identifying underlying CCA,5 which in turn may allow transplantation6 and improvement in survival. Indeterminate Biliary Strictures
An indeterminate biliary stricture is defined as one that has defied diagnosis despite serum laboratory examination, imaging studies, and histologic sampling. Repeat ERCP with cholangioscopy can be useful in visualizing the stricture and allowing directed biopsies to allow a diagnosis to be established.7 It must be emphasized that cholangioscopy in the setting of PSC is less reliable than in those patients with de novo strictures, because the endoscopic appearance of benign strictures and malignant strictures can be similar.8 There are two methods of cholangioscopy: passage of a cholangioscope through the working channel of the ERCP scope (Fig. 2); and
Fig. 1. Diagnostic cholangiogram for primary sclerosing cholangitis. Note occlusion balloon is inflated below cystic duct take off to maximize contrast filling of the intrahepatic ducts.
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Fig. 2. Cholangioscopy using a prototype video cholangioscope. (A) Radiographic image showing the cholangioscope passed to the bifurcation. A biopsy forceps is seen extending from the cholangioscope. (B) Cholangioscopic image (right) of stricture. Note inset from of the endoscopic image from the ERCP scope shows the cholangioscope in the duodenum entering the papilla.
passage of a small-caliber forward-viewing endoscope (4.9 mm) directly into the bile duct.9,10 The latter is referred to as direct peroral cholangioscopy11,12 and can be technically challenging because the mechanics and angulation do not easily permit a forward-viewing endoscope to be passed directly into the bile duct. However, the optics achieved with these forward-viewing endoscopes are superior (video rather than fiberoptic) and the endoscope has a larger working channel than do cholangioscopes passed through the ERCP channel. Another, recently introduced technologic advancement is the use of probe-based confocal laser endomicroscopy. The probe is passed into the bile duct through the endoscope and allows real-time histologic images of the biliary epithelium. It has shown promise for determining malignancy in patients with and without PSC.13,14 Sphincter of Oddi Manometry
Postcholecystectomy biliary-type pain may be a manifestation of sphincter of Oddi dysfunction (SOD).15 SOD is classified clinically as type I, II, or III. Type I SOD patients have elevated liver tests during an attack that normalize between attacks and a dilated bile duct by imaging. Type II SOD patients have either abnormal liver tests during an attack or a dilated bile duct, but not both. Type III SOD patients have pain only and no objective pancreaticobiliary laboratory or imaging abnormalities. Type I SOD patients respond uniformly to endoscopic sphincterotomy (ES) and manometry is not needed for diagnosis or therapy. Elevated biliary pressures found during SOD manometry at the time of ERCP can predict response to ES in patients with type II SOD.15 The data to support the use of SOD manometry in patients with type III SOD are lacking,15,16 but is offered for those patients who have disabling pain and who understand the risks of potentially fatal and/or disabling adverse effects. THERAPEUTIC ERCP
The most common therapeutic uses of ERCP are the management of common bile duct (CBD) stones and relief of malignant obstruction. However, the range of therapeutic options for biliary disease has exploded (see Box 1).
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CBD Stones
The success rate of ERCP for removal and clearance of CBD stones less than 1.5 cm in the absence of underlying strictures, using ES, balloons, and/or baskets, is nearly 100% when performed by experienced endoscopists. The need for mechanical lithotripsy or intraductal therapy (laser and electrohydraulic lithotripsy) for extraction of large bile duct stones has become less common with the use of combined ES and large-diameter balloon dilation17,18 (12 mm and up to 20 mm) (Fig. 3). This combination enlarges the lumen of the distal bile duct and sphincterotomy opening, the major limitations to successful extraction of large stones. The use of endoscopic balloon dilation alone to extract stones as an alternative to ES has fallen out of favor in the United States because of the higher risk of post-ERCP pancreatitis.19 However, it is useful for selected patients with smaller stones who are at high risk of bleeding (coagulopathy, thrombocytopenia, antithrombotic agents), and perforation (Billroth II anatomy). Benign Biliary Strictures
There are a variety of causes of benign biliary strictures (BBS). Endoscopic therapy for most BBS consists of balloon dilation and placement of plastic biliary stents.20,21 It has
Fig. 3. Combined endoscopic sphincterotomy and large diameter balloon dilation for removal of large bile duct stone. (A) Cholangiogram shows large filling defect. (B) Endoscopic view of 15-mm balloon inflated across sphincterotomy site. (C) Large stone extracted and in the duodenum.
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been shown that placement of multiple side-by-side plastic stents (Fig. 4) that remain in place for 6 to 12 months provides the best results and avoids surgery in more than 90% of patients. Recurrences can be retreated with more aggressive and longerduration stent placement. The use of fully covered self-expandable metal stents (SEMS), which reach diameters up to three times that of rigid plastic stents, has shown
Fig. 4. Endoscopic treatment of an anastomotic biliary stricture after liver transplantation. (A) Initial cholangiogram demonstrates anastomotic stricture. (B) After balloon dilation placement of multiple plastic stents are seen across the stricture. (C) Final cholangiogram at the time of stent removal shows resolution of stricture.
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promise in the treatment of BBS not involving the bifurcation,20 although they are expensive and not approved in the United States for use in benign disease. Bile Duct Leaks
Nearly all bile leaks are postsurgical and occur after biliary surgery, usually cholecystectomy. Leaks are maintained by the high-pressure biliary sphincter. Ablation of the pressure gradient is achieved by endoscopic biliary sphincterotomy, placement of short length biliary stents,22 or a combination of the two (Fig. 5). Placement of a biliary stent across the leak site is generally only necessary when the leak site involves the main duct or biliary anastomosis. As in the treatment of BBS fully covered metal stents can be effective, but are not approved for such treatment and if used should be reserved for cases refractory to standard endoscopic therapy.22,23 Transpapillary Gallbladder Drainage
Transpapillary gallbladder drainage is achieved by ERCP after cannulation and passage of a guidewire across the cystic duct into the gallbladder. A plastic stent is placed with one end in the gallbladder lumen and the other in the duodenum (Fig. 6).24 In some cases of severe cholecystitis a nasocholecystic tube is initially placed and later exchanged to an internal transpapillary stent. The success rate for placement is high in centers with experience in advanced endoscopy. The procedure can be completed without performing an ES in patients with high risk of bleeding and is especially useful when percutaneous drainage fails or is not feasible.25 Ampullary Adenoma
Ampullary adenomas are being increasingly discovered incidentally during endoscopy performed for other reasons. Although the term endoscopic ampullectomy is typically used, the anatomically correct term is endoscopic papillectomy.26 Complete endoscopic resection is feasible even for large lesions (Fig. 7). The main
Fig. 5. Treatment of a postsurgical bile leak. (A) Cholangiogram shows extravasation of contrast. A 10F catheter transpapillary biliary stent was placed across the leak site. (B) Follow-up cholangiogram after stent removal shows absence of leak, but with mild stricture.
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Fig. 6. Endoscopic transpapillary drainage of nonoperative drainage of cholecystitis in a 91-year-old nonoperative patient. (A) Cholangiogram showing guidewire passed into gallbladder passed across obstructing stone in the neck of the gallbladder and cystic duct. (B) Radiographic image with stent placed into gallbladder neck beyond the stone.
Fig. 7. Endoscopic papillectomy. (A) Endoscopic appearance of large periampullary lesion. (B) Gross picture of lesion after endoscopic resection. (C) Endoscopic appearance of resection site.
Endoscopy and Biliary Disorders
limitation to eradication is intraductal extension greater than 1 cm. The presence of cancer can be anticipated if ulceration, firmness, or spontaneous bleeding is identified at the time of endoscopy and is suspected preprocedurally with a presentation of obstructive jaundice in the absence of underlying choledocholithiasis. Resection techniques are similar to polypectomy in other areas except for the use of a sideviewing endoscope. Prophylactic pancreatic duct stents are placed to prevent post-ERCP pancreatitis. For large polyps, especially those with lateral extensions along the duodenal wall, more than one endoscopic procedure is often necessary for complete eradication. Surveillance endoscopy is necessary with the intervals based on histopathology and presence of residual disease on initial follow-up endoscopy.27 Malignant Biliary Obstruction Distal (nonhilar) malignant obstruction
Malignant distal biliary obstruction is effectively treated using a single stent. Obstruction is relieved as effectively as surgical biliary bypass with lower morbidity and mortality, although with an increased rate of reobstruction when 10F catheter plastic stents are used.28 These 10F catheter stents are fixed and are the largest that are passed through a standard therapeutic channel endoscope. Because of the threefold increase in final diameter biliary SEMS have significantly longer patency durations than 10F catheter plastic stents and decrease the need for reintervention when used for palliation of malignant distal obstructive jaundice (Fig. 8). They are also costeffective when used for patients who survive more than 3 to 4 months.28 The first available biliary SEMS were bare metal; later covered SEMS were introduced to reduce tumor ingrowth through the stent spaces (interstices) and potentially prolong patency. The superior patency of covered SEMS remains unproven with contrasting results seen between two meta-analyses.29,30 Advantages of covered SEMS are removability and ease of revision compared with uncovered SEMS, which become imbedded into the surrounding bile duct. Removability may become of upmost importance in patients in whom a tissue diagnosis was not confirmed at the time of placement and who are later found to have benign disease (eg, autoimmune pancreatitis) or curable malignancy (eg, lymphoma31). In patients undergoing biliary stent placement for preoperative decompression, plastic stents are generally used.32,33 SEMS are useful for those patients who will have delay in surgery, such as those patients with pancreatic cancer undergoing neoadjuvant therapy.33,34 Short-length uncovered (nonremovable) SEMS do not preclude subsequent pancreaticoduodenectomy.34 Hilar malignant obstruction
The approach to hilar biliary obstruction is much less straightforward than for distal obstruction28,35 and may be more likely to require percutaneous drainage, depending on endoscopist expertise. Factors that determine unilateral versus bilateral stent placement for palliation of hilar obstruction include potential resectability, Bismuth classification, presence and location of liver atrophy, intrahepatic tumor burden (Fig. 9), and presence of PSC.36 Hilar cases are technically challenging for a variety of reasons. Avoidance of widespread contrast injection is essential to minimize contamination of intrahepatic ducts, and thereby minimize cholangitis resulting from a contaminated, undrained system. Thus, to avoid contrast injection guidewires are passed into intrahepatic ducts without contrast injection using an image-guided approach (computed tomography, MRI). The advantages of SEMS placement are not as clear-cut as for nonhilar obstruction, and reintervention for management of
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Fig. 8. Endoscopic palliation of a distal malignant biliary stricture caused by metastatic breast cancer. (A) Cholangiogram shows long distal bile duct stricture involving the cystic duct take off. Note dilated cystic duct. (B) Radiograph immediately after covered selfexpandable metal stent placement. (C) Endoscopic photo of stent exiting the papilla.
stent occlusion when bilateral stents are placed is often difficult.28 In patients who have SEMS placed for palliation of more advanced hilar CCA there is a greater need for reintervention because of stent occlusion.37 Therapies that can be delivered endoscopically for hilar CCA to prolong palliation include photodynamic therapy38 and, more recently, radiofrequency ablation.39 The use of endoscopically delivered brachytherapy, either low- or high-dose, is now reserved predominately for protocols that allow subsequent liver transplantation.6,40 Therapeutic ERCP in Patients with Surgically Altered Anatomy
ERCP was once considered impossible in patients with altered surgically anatomy. Initially, patients with Billroth II anatomy and biliary disease were successfully approached. With increasing experience, initially using colonoscopes,41 followed by advances in endoscopic technology, particularly balloon enteroscopy, endoscopic biliary therapy can be achieved in patients with post-Whipple anatomy and patients
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Fig. 9. Palliation of malignant hilar obstruction with unilateral metal stent. (A) MRI shows extensive tumor into right system. A dilated left duct can be seen. (B) Access into left system with avoidance of extensive contrast into right system. (C) Placement of uncovered expandable metal stent across stricture into left system proximally and bile duct distally.
with Roux-en-Y anastomoses with high success rates in centers with experience (Fig. 10).42 Unfortunately, biliary cannulation is technically difficult in patients with native papillae because colonoscopes and balloon enteroscopes are forward-viewing rather than side-viewing. ERCP can be performed in patients with Roux-en-Y gastric bypass using a laparoscopic-assisted approach that allows access to the excluded stomach and antegrade passage of a standard side-viewing duodenoscope into the duodenum.43 Novel Percutaneous-Endoscopic Access Approaches
Novel percutaneous-endoscopic access approaches have recently been described to treat biliary diseases.44 Recently termed “percutaneous assisted translumenal endoscopic therapy”45 has been used to treat gallbladder disease and to access the excluded stomach to pass antegrade duodenoscopes in patients with Roux-en-Y gastric bypass anatomy such that management of CBD stones can be achieved entirely endoscopically.46 ENDOSCOPIC ULTRASOUND Diagnostic EUS
EUS has now become a standard part of biliary diagnostics because it is less-invasive than ERCP. EUS is extremely sensitive for the diagnosis of gallbladder sludge, cholelithiasis, and microlithiasis and can establish these diagnoses in patients with
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Fig. 10. Endoscopic treatment of a choledochojejunal (CJ) anastomotic stricture after pylorus-sparing Whipple. (A) Radiographic image on reaching the CJ using a single balloon enteroscope. (B) Cholangiogram showing focal narrowing of CJ. (C) Balloon dilation of CJ stricture yielded excellent result.
suspected biliary pancreatitis who have negative transabdominal ultrasound studies.47 EUS is also sensitive for the diagnosis of CBD stones and is especially useful for patients with suspected CBD stones in whom other imaging studies (transabdominal ultrasound, MRCP) are nondiagnostic. Linear-array EUS allows directed tissue acquisition using fine-needle aspiration techniques and is helpful in establishing a tissue diagnosis of malignant biliary strictures when other modalities are negative,48 for staging of CCA49 and other biliary malignancies, and to evaluate for the presence of lymph node involvement in patients with malignant biliary strictures. Therapeutic EUS Biliary drainage
Applications of therapeutic EUS for biliary disease are now becoming realized. Although EUS to provide biliary access for ERCP using a rendezvous approach is well-established, direct biliary drainage is now becoming an increasingly used
Endoscopy and Biliary Disorders
approach.50 This is because newer accessories specifically designed to access and drain the biliary tree through fine-needle aspiration wire-guided entry are emerging. This allows reliable and safe drainage accessing intrahepatics ducts through the stomach into the left lobe (hepaticogastrostomy), through the duodenum into the bile duct (choledochoduodenostomy), and by accessing these sites and internalizing drainage through the papilla without a rendezvous approach.51,52 EUS-guided biliary drainage is especially helpful where access to the papilla is not possible because of duodenal obstruction.53 Gallbladder drainage
Transgastric and transduodenal drainage of the gallbladder using EUS guidance is an alternative to percutaneous cholecystostomy in patients with acute cholecystitis54 who are poor operative candidates for cholecystectomy. The main advantage of an EUS approach is avoidance of percutaneous drains, which may be life-long if patients are not operative and/or have underlying malignancies.55 Indeed, gallbladder stone clearance can be achieved endoscopically across such internally created tracts.56 Drainage of liver abscesses
Historically liver abscesses have been performed nonsurgically using percutaneous approaches. Recently, transgastric drainage using EUS-guided transgastric approaches have been described and can be performed when percutaneous therapy fails.57 Drainage of bilomas
Similar to liver abscesses, bilomas are usually drained percutaneously. EUS-guided drainage of bilomas through the stomach is an alternative approach.58 ADVERSE EVENTS
Adverse events (AEs) of ERCP and EUS are well-known and include sedation, bleeding, perforation, pancreatitis, infection, bile leakage, and death.59–61 Risk factors for AEs include operator characteristics, patient risk factors, and degree of invasiveness of the procedure. In patients at high risk for post-ERCP pancreatitis the use of rectally administered indomethacin immediately after the ERCP significantly reduces the risk, as does placement of a temporary pancreatic duct stent.62 Fortunately, most AEs can be managed medically, with repeat endoscopy, and/or by percutaneous means. Several types of perforations may occur after ERCP and most can be managed nonsurgically.63 Improved recognition and closure devices allow nonoperative treatment of lateral wall perforations. However, it is important to have all disciplines available (hospitalists, critical care intensivists, interventional radiologists, and surgeons) to manage patients with AEs. Other ERCP-related AEs include stent migration (proximally or distally). EUS-transmural therapies can result in leakage between the puncture site and the biliary tree, perforation, and bleeding. SUMMARY
Endoscopic therapy for biliary diseases has progressed markedly over the last 30 years and has become a mature field. A wide array of biliary diseases can be treated endoscopically using ERCP, with high success rates and low AE rates in experienced centers. EUS is now established as a diagnostic tool for biliary diseases and is also emerging as a therapeutic tool for biliary diseases. Future advancements in ERCP and EUS are expected.
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REFERENCES
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