Abstract
Most patients with pancreatic cancer develop obstructive jaundice. Management of malignant biliary obstruction is dependent upon factors such as certainty of the diagnosis, symptoms, and resectability status of the patient. Tissue sampling during endoscopic retrograde cholangiopancreatography (ERCP) has a relatively low sensitivity but high specificity. Surgical resection is the only potentially curative treatment option. Patients with obstructive jaundice have various pathophysiological changes that affect the liver, kidney, heart, and the immune system, potentially increasing the risk of postoperative complications following pancreaticoduodenectomy. However, the role of routine preoperative biliary drainage (PBD) in the management of jaundiced patients with resectable pancreatic cancer is controversial. Most clinical studies have failed to show a clear advantage for patients undergoing PBD and have advised against routinely performing these procedures. PBD appears to increase overall morbidity because of procedure-related complications, especially if plastic stents are used for biliary decompression. Self-expandable metal stents (SEMS) have a longer patency and could reduce the risk of stent-related complications due to early occlusion. PBD may be beneficial in selected patients including those with cholangitis, when surgery is delayed, or when neoadjuvant therapy is planned. ERCP with placement of a short SEMS is the preferred modality and does not interfere with subsequent pancreaticoduodenectomy. Percutaneous and EUS-guided biliary drainage procedures are useful alternatives when ERCP is unsuccessful. SEMS placement is useful as palliation for patients with unresectable disease.
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Keywords
- Preoperative biliary drainage
- Pancreatic cancer
- Borderline resectable pancreatic cancer
- Obstructive jaundice
- Neoadjuvant therapy
- Biliary self-expandable metal stent
- Plastic biliary stent
- Percutaneous biliary drainage
- ERCP
- EUS-guided biliary drainage
Introduction
Biliary drainage procedures for management of obstructive jaundice secondary to pancreatic cancer are frequently performed in clinical practice. Pancreatic cancer accounts for approximately 3 % of all cancers seen in the USA, and it is estimated that approximately 48,960 new cases will be seen in the USA in 2015 with 40,560 deaths [1]. This potentially fatal disease accounts for about 7 % of cancer deaths and is the fourth leading cause of cancer-related deaths among men and women [2].
Patients with pancreatic cancer often present with biliary obstruction as approximately 80 % of these neoplasms occur in the head of the gland. Jaundice, with or without pain, is seen in over half of patients who present with resectable, borderline resectable, or locally advanced disease [3, 4]. In other patients, jaundice develops later in the course as the disease progresses. Jaundice is typically a late finding when the primary tumor is located in the tail of the pancreas and often reflects metastatic disease. Surgical resection offers the only potential for curative treatment. However, only 15–30 % of patients are candidates for curative-intent surgery as the majority present at a more advanced stage and have either locally advanced or metastatic disease.
Obstructive jaundice may result in severe pruritus, progressive hepatocellular dysfunction, coagulopathy, malabsorption, and cholangitis [5]. Biliary decompression may be accomplished by surgical, radiologic, or endoscopic techniques. Although these modalities are equally effective in relieving biliary obstruction, endoscopic drainage via placement of a biliary stent (plastic or metal) during ERCP is generally considered safer, less invasive, and is preferred for most patients when technically feasible [6, 7]. PBD has been advocated largely in an attempt to reduce postoperative complications following surgical resections. This is based upon the rationale that pathophysiological derangements seen in the setting of biliary obstruction could potentially be reversed by restoring bile flow and ultimately translate into improved clinical outcomes.
Despite the fact that endoscopic and percutaneous drainage procedures are technically successful in 90–95 % of cases [5], the role of PBD remains controversial. Clinical studies have reported both beneficial and adverse effects, and most studies have advised against routine PBD due to the potential for procedure-related complications such as bleeding, perforation, pancreatitis, bacterial colonization of bile, and complications of stent occlusion such as cholangitis. Nevertheless, PBD is often considered necessary in clinical practice for selected patients. Most clinicians recommend PBD for the following clinical scenarios: (1) Patients with resectable disease who have surgery delayed for logistical reasons, (2) The resectability status may not be known with certainty at the time of initial ERCP, (3) To facilitate neoadjuvant chemoradiation in patients with borderline resectable cancer, (4) Management of cholangitis (or severe pruritus), (5) Palliation of jaundice in patients with unresectable disease. This chapter will focus on biliary drainage procedures and their role in management, diagnosis, and palliation of patients with obstructive jaundice due to pancreatic cancer.
Role of ERCP in the Diagnosis of Pancreatic Cancer
ERCP is a highly sensitive modality for visualization of the biliary tree and pancreatic ducts. It also provides the opportunity to obtain tissue samples and perform therapeutic maneuvers. However, with advances in cross-sectional imaging and endoscopic ultrasound (EUS), the role of ERCP in patients with suspected pancreatic cancer has evolved into a mainly therapeutic modality for patients with biliary obstruction and require decompression. ERCP alone provides little staging information for pancreatic cancer.
Certain endoscopic and radiographic features observed during ERCP should alert the endoscopist to the possibility of pancreatic cancer. The presence of mucus extrusion from the papillary orifice is compatible with a main duct intraductal papillary mucinous neoplasm (IPMN), a condition that may lead to the development of pancreatic ductal adenocarcinoma. The pancreatogram in such cases might also reveal intraductal mucin which is seen as a filling defect within the pancreatic duct (Fig. 4.1). Direct invasion of the ampulla or duodenal wall caused by a neoplasm in the head of the pancreas is sometimes seen endoscopically. Standard forceps biopsies may yield a diagnosis in these cases (Fig. 4.2). Mass lesions in the head of the pancreas often cause simultaneous obstruction of the common duct and pancreatic duct (i.e., double-duct sign). At ERCP, this appears as a focal stricture of the common bile duct and pancreatic duct, typically with associated upstream dilation of both ducts (Fig. 4.3). Other features of a stricture which are suggestive of malignancy include an abrupt cutoff of the pancreatic duct, a ragged contour, or stricture length >1 cm. These radiographic features are helpful but nondiagnostic and may occasionally be found in benign conditions such as chronic pancreatitis. The presence of a stricture in the pancreatic duct and/or bile duct must be interpreted in clinical context, but generally leads to tissue sampling during ERCP if the diagnosis remains in question as a definitive diagnosis of malignancy requires tissue confirmation.
Tissue sampling techniques during ERCP include brush cytology, forceps biopsy, aspiration of bile or pancreatic juice for cytology, or a combination. In patients in whom a plastic stent has already been placed, the stent can be spun and the cells obtained can be evaluated [8]. Exfoliated malignant cells may be adherent to the surface of the stent as they become entrapped within biofilm and sludge. The sensitivity rate for ERCP-directed brush cytology or biopsy is 30–50 %, with a combination of techniques achieving sensitivity rates of approximately 70 % [9, 10]. This is considerably less than EUS-guided fine needle aspiration (FNA) which has a sensitivity of approximately 85–90 % for the diagnosis of pancreatic cancer [11]. Several studies have shown that diagnostic yield during ERCP can be increased by using a combination of different tissue sampling methods [12, 13]. Unfortunately, the negative predictive value in tissue sampling during ERCP using a combination of techniques is nearly 40 % [12].
Although aspiration of bile or pancreatic juice is simple to perform, fluid cytology alone has a low sensitivity and is not performed by most endoscopists. Fluid specimens are often acellular, likely due to the desmoplastic nature of certain tumors or failure to invade the ductal epithelium. Techniques to increase tumor exfoliation prior to collecting specimens, such as stricture dilation or saline irrigation, have not demonstrated increased cancer detection rates in prospective comparative trials [12]. Forceps biopsies have a higher yield, but generally require a sphincterotomy to gain access to the bile duct or pancreas. When performing forceps biopsies, it may be helpful to first place a guidewire across the stricture to maintain access and for use as a guide for cannulation and positioning of the biopsy forceps (Fig. 4.4). Performing intraluminal forceps biopsies during ERCP can be technically challenging as the device cannot be passed over a guidewire. It may also increase the risks of the procedure, including bleeding, pancreatitis, and perforation. By comparison, biliary brush cytology is relatively easy to perform as the brush passes over a prepositioned guidewire to acquire a specimen within the stricture. The overall technical success rate of biliary brush cytology is >90 %. Brush cytology in the pancreatic duct is sometimes helpful but is frequently more difficult to perform. Pancreatic cancer often causes tight strictures of the main pancreatic duct which prohibit passage of the brush through the tumor in greater than 25 % of patients [12] (Fig. 4.4). Because of the aforementioned challenges, most practitioners perform biliary brush cytology alone, which has sensitivity as low as 30 %. Although the sensitivity of brush cytology or forceps biopsy alone is suboptimal, both techniques are almost 100 % specific [13]. Advanced techniques such as digital image analysis may enhance the accuracy of routine cytology [14], but is not widely available. Additional methods to improve the diagnostic yield such as the molecular analysis of the components of pancreatic juice and bile remain experimental [9, 15, 16]. Although the overall performance of tissue sampling techniques during ERCP in patients with suspected pancreatic cancer is significantly lower than EUS-FNA, it remains an important modality and should be performed whenever a diagnosis has not been established at the time of the procedure.
Rationale for Preoperative Biliary Drainage
Historically, major hepatobiliary surgical procedures in patients with obstructive jaundice have been associated with significant morbidity and mortality, largely due to the development of postoperative complications such as sepsis, bleeding disorders, and renal failure. Biliary obstruction has been regarded as a risk factor that can worsen the outcome after surgery [17]. The primary rationale of PBD for patients with biliary obstruction due to pancreatic cancer is to reduce the risk of postoperative complications. The concept of PBD was introduced by A.O. Whipple and colleagues in 1935 when they published one of the first case series of PBD for patients with periampullary cancer [18]. The two-staged technique involved performing a preliminary open biliary diversion procedure (cholecystogastrostomy) to reduce jaundice, followed by resection of the primary tumor at a later stage, depending on the severity of jaundice. The goal of this approach was to optimize the overall physical status of the patient prior to definitive resection.
Biliary obstruction is associated with several deleterious effects. Animal studies have shown that obstructive jaundice leads to a proinflammatory state resulting from portal and systemic endotoxemia [19]. Decreased bile in the intestinal lumen causes increased permeability of the intestinal mucosal barrier, promoting bacterial translocation and the occurrence of endotoxemia [20]. Systemic endotoxemia leads to impaired cellular immunity and increased concentrations of proinflammatory cytokines such as interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-8 (IL-8), and tumor necrosis factor (TNF) [21–23]. The overall effects of obstructive jaundice in humans on endotoxin and cytokines may be different from those seen in animal models [24]. Biliary obstruction also causes a reduction in hepatic reticuloendothelial system function leading to a diminished clearance of endotoxin by Kupffer cells [24, 25]. Persistent elevation of cytokines has been associated with protein calorie depletion, a factor associated with higher surgical complications which could potentially be reversed by biliary decompression. Malignant biliary obstruction may also adversely affect coagulation due to bile acid-induced hepatocyte damage [26] as well as impaired hepatic synthesis of vitamin K-dependent coagulation factors secondary to reduced vitamin K absorption from the intestine. Despite these effects favoring bleeding complications, a recent study has shown that patients with severe biliary obstruction may also develop a procoagulant state which was almost completely reversed by preoperative endoscopic biliary drainage [27]. In addition to impairment of immune function and coagulopathy, biliary obstruction is also associated with renal dysfunction. Cholestatic jaundice is known to have deleterious effects on cardiovascular function, blood volume, and vascular reactivity. The overall effect of obstructive jaundice predisposes the kidney to prerenal failure and acute tubular necrosis. Most evidence suggests that the constituents of bile (cholesterol, bilirubin, bile acids) do not exert a direct nephrotoxic effect [28]. A multivariate analysis has shown that renal dysfunction in patients with obstructive jaundice is associated with the degree of biliary obstruction as well as the age of the patient [29]. Biliary obstruction may also be associated with impaired myocardial function and is associated with increased plasma levels of atrial natriuretic peptide (ANP). Internal biliary drainage results in improvement in cardiac function and normalization of ANP [30].
The adverse effects of biliary obstruction on multiple organ systems and immune function may adversely impact the outcome after major surgery for patients with pancreas cancer. Preoperative biliary drainage has the potential to improve surgical outcomes by reversing the detrimental effects via restoration of bile flow.
Methods of Preoperative Biliary Drainage
Endoscopic stent placement and percutaneous biliary drainage have largely replaced surgical biliary bypass for management of biliary obstruction due to pancreatic cancer. These techniques are generally considered less invasive, less expensive, and have a shorter recovery time as compared to surgical procedures. The choice between endoscopic vs. percutaneous biliary drainage is often a matter of a local expertise and patient anatomy, although endoscopic stent placement is preferred whenever possible due to fewer procedure-associated complications [31]. Percutaneous biliary drainage is more often used when endoscopic stent placement is unsuccessful or not technically possible due to altered anatomy (e.g., duodenal obstruction, tumor invasion of the ampulla, or previous surgical bypass procedures).
Percutaneous Biliary Drainage
Percutaneous transhepatic biliary drainage (PTBD) was introduced in the 1960s and was the treatment of choice for biliary drainage for over two decades [32, 33]. PTBD drainage is most often performed using fluoroscopic guidance although ultrasound can be helpful for the initial puncture when the bile ducts are dilated [34]. The technique involves passing a skinny needle (21 or 22 gauge) through the hepatic parenchyma until reaching a dilated intrahepatic bile duct. A percutaneous cholangiogram is performed by injecting contrast as the needle is slowly withdrawn, followed by passage of a small diameter (0.018 in.) guidewire to secure the position in the biliary tree. Once the dilated duct has been accessed with the needle, the needle is exchanged for a coaxial system to upsize the 0.018-in. access guidewire to a larger guidewire (e.g., 0.035 or 0.038 in.) which is more stable and can be used for further interventions.
PTBD can provide biliary drainage in three ways. The simplest of these is external drainage which involves decompressing the biliary tree through a percutaneous tube which exits the skin, but the intraductal tip is left upstream to the site of biliary obstruction. The method is typically used when a tight stricture cannot be traversed with a guidewire after percutaneous access to the biliary tree has been achieved. A major disadvantage of external drainage is the fact that bile flow to the duodenum is not restored. For internal–external drainage, a directional catheter is inserted through the percutaneous sheath and advanced over a hydrophilic guidewire through the biliary obstruction and into the duodenum. The catheter can then be exchanged over a stiffer guidewire (e.g., Amplatz) for a multiside-hole drainage catheter which is passed through the stricture into the duodenum. The internal–external catheter allows bile to drain externally into a bag and/or internally into the duodenum, thereby preserving the normal enterohepatic circulation of bile (Fig. 4.5). The third technique establishes internal drainage by percutaneous placement of a plastic or self-expandable metal stent (SEMS) across the biliary stricture. Recent studies have shown percutaneous SEMS placement to be a safe and effective technique [35–38]. Although it is common practice to establish initial internal–external drainage prior to SEMS placement, some experienced centers have reported good results with percutaneous SEMS insertion as a single-stage procedure [35, 36]. A retrospective study from the UK reported an overall technical success rate of 79 % among 67 patients undergoing percutaneous short SEMS placement for biliary obstruction due to pancreatic or periampullary tumors [35]. The complication rate was 9.4 % although all complications were managed conservatively and none precluded subsequent surgery.
One disadvantage of PTBD is that it cannot be used in the presence of moderate or severe ascites [39]. PTBDs can be cumbersome for patients to manage and require significant maintenance. External drains require periodic emptying, flushing of the drain, and drain exchanges to prevent occlusion [40]. PTBDs can also be prone to leakage, dislodgement, and complications such as hemobilia and infection. A recent prospective study involving 109 patients with advanced malignancy showed that PTBD improved pruritus and hyperbilirubinemia, but not overall quality of life [41]. Despite potential drawbacks, PTBD continues to have an important role for management of biliary obstruction, especially when ERCP is unsuccessful [42].
Endoscopic Biliary Drainage
The most common and generally preferred method of achieving preoperative biliary drainage is by ERCP with stent placement. Endoscopic stents are often used as a bridge to surgery for patients with resectable or borderline resectable disease as well as for long-term palliation for unresectable pancreatic cancer. The main advantage of an endoscopic approach over PTBD is the avoidance of skin and liver punctures as well as the risk of tumor seeding which may occur along the catheter and to the skin [43]. Recent meta-analyses have suggested that endoscopic stenting provides superior results to open surgical bypass in patients with distal biliary obstruction due to pancreatic cancer [7, 44]. Biliary drainage may be achieved using either plastic stents or SEMS and it is now clear that stent luminal diameter is a critical factor for both types as the risk of stent occlusion correlates with stent diameter. In general, wider diameter stents have a lower risk of short-term occlusion, whether plastic or metal.
Plastic biliary stents have been used since their development in the 1980s and are now commercially available in a wide variety of diameters, lengths, and designs (Fig. 4.6). They may be composed of various materials including polyethylene, polyurethane, and Teflon. Plastic biliary stents are available in diameters ranging from 5 to 12 Fr and lengths from 1 to 18 cm [45]. The primary advantages of using plastic stents for malignant biliary obstruction are that they are effective, have lower costs, and are easily removed or exchanged. Plastic stents are often selected when a diagnosis has not been established or the patient’s resectability status is unknown at the time of initial endoscopic treatment. The major disadvantage of plastic stents is that they have a high rate of occlusion due to formation of bacterial biofilm, sludge, as well as dietary fibers [46] (Fig. 4.7); this leads to the need for repeat procedures and stents exchanges. In general, 7 Fr plastic stents remain patent for approximately 8 weeks whereas 10 Fr plastic stents remain patent for an average of 3–5 months [47]. It is important to note that plastic biliary stents often do not maintain patency during the time required for most patients to complete neoadjuvant chemoradiotherapy for pancreatic cancer. A recent retrospective study reported that among 49 patients treated with plastic stents who were undergoing neoadjuvant therapy, 55 % required repeat ERCP for stent malfunction at a median of 82.5 days after initial stent placement [48]. Studies evaluating stent designs have compared stents composed of Teflon without side holes to standard polyethylene stents with side holes. No difference in patency rates was found based upon stent composition or design [49, 50]. Although it is generally accepted that larger diameter plastic stents (10 Fr or greater) have a longer patency than smaller diameter stents, a study comparing 10–11.5 Fr stents found no difference in patency rates [51]. A Cochrane meta-analysis found that choleretic agents such as ursodeoxycholic acid (UDCA) and/or antibiotics do not appear to improve plastic stent patency rates [52].
SEMS are now widely used for management of malignant biliary obstruction. As with plastic stents, SEMS are available in a variety sizes and designs (Fig. 4.8). Multiple studies have shown that when compared to plastic stents, SEMS have a superior patency rate when used for preoperative biliary decompression due to pancreatic cancer [7, 48, 53–58] (Fig. 4.9). The improved patency of SEMS relates to the fact that when fully deployed, SEMS have a roughly threefold wider luminal diameter than most plastic stents. Longer stent patency is especially important as more centers adopt neoadjuvant therapy as a standard of preoperative care. Stent occlusions during this period can result in severe complications such as cholangitis as well as interruptions in therapy, hospitalizations, unplanned procedures, and delays in eventual surgery [59]. In a recent prospective study evaluating SEMS in 55 patients undergoing neoadjuvant therapy for pancreatic cancer, only 15 % experienced stents malfunctioned by 260 days after placement [60]. This compares favorably to a 55 % stent malfunction rate when plastic stents were used for a similar patient population [48]. Another retrospective study evaluating plastic stents and SEMS for preoperative biliary decompression reported a 39 % stent dysfunction rate for those who received plastic stents compared to no stent dysfunction for those who received an SEMS [54]. Adams et al. evaluated stent complications among 52 patients who underwent placement of either a plastic stent or SEMS to receive neoadjuvant therapy for pancreatic cancer [57]. The complication rate was nearly seven times higher with plastic stents than with SEMS. Moreover, the rate of hospitalization for stent-related complications was threefold higher in the plastic stent group than the SEMS group.
One factor that led to the initial use of plastic stents for preoperative biliary decompression was the concern that uncovered SEMS could potentially cause technical difficulties with transecting the bile duct and creating a biliary anastomosis during subsequent pancreaticoduodenectomy. Studies have now shown that placement of a short-length SEMS (typically 4–6 cm length) does not interfere with the outcome of surgery [5, 54, 61–63]. Siddiqui et al. reported the outcome of 241 patients with resectable or borderline resectable disease who underwent preoperative SEMS placement [63]. Uncovered, partially covered, and fully covered SEMS were used. Ultimately, 166 patients underwent curative-intent surgery without any observed technical difficulties during surgery due to the presence of an SEMS. Similarly, Mullen et al. found no difference in intraoperative or postoperative complications, or length of hospital stay among 29 patients who underwent pancreaticoduodenectomy after SEMS placement compared to those who had plastic stents (n-141), no stent (n-92), or biliary bypass (n-10) prior to surgery [64]. It is advisable during stent placement to use the shortest length SEMS possible to bridge the stricture with care taken to leave an adequate length of common hepatic duct un-stented (ideally 2 cm) to simplify any future surgical anastomosis, especially if using an uncovered SEMS. The choice between plastic stent vs. SEMS may ultimately rely on other factors such as cost, expected survival length, and certainty of diagnosis at the time of initial ERCP.
Although SEMS remain patent longer than plastic stents, they are also at risk for occlusion due to tumor ingrowth through the mesh interstices, overgrowth beyond the ends of the stent, or due to a hyperplastic response of normal tissue caused by the stent (Fig. 4.10). For this reason, SEMS were developed which are partially or fully covered with a goal of improving patency by preventing tumor and tissue ingrowth. Coverings include material made of polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene/fluorinated ethylene propylene (ePTFE/FEP), or silicone membranes. The covering may be on the exterior or interior of the stent. Some fully covered stents have fenestrations in the cover without exposing the metal wires. Unfortunately, covered stents may also occlude due to stent migration, tumor/tissue overgrowth, tumor ingrowth as the covering deteriorates over time, or possibly due to food debris [40]. Reflux of duodenal contents into SEMS is also known to occur [65] and could potentially cause problems in some patients. One of the advantages of uncovered SEMS, which has been shown in several studies, is their low migration rate (0–2 %) [56, 66, 67]. This is presumably due to embedding of the stent into the wall of the bile duct after deployment. Covered SEMS have a higher migration rate of approximately 6–8 %. Partially and fully covered stents have the advantage that they can be repositioned or fully removed using a rat-tooth forceps or snare [45]. SEMS are available in 6, 8, and 10 mm diameters when fully deployed, which is a key feature in determining the risk of occlusion. A large prospective multicenter study randomized 241 patients with malignant biliary strictures to receive uncovered SEMS of different designs in two diameters (i.e., 6 mm Zilver, 10 mm Zilver, or 10 mm Wallflex). SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature [68]. Similarly, Yang et al. showed no significant difference in the rate of occlusion when using uncovered SEMS of equal diameter, but different stent design [69].
Studies comparing the differences in patency rates between covered and uncovered SEMS in patients with malignant distal bile duct obstruction have shown conflicting results. For example, two randomized multicenter trials found no difference in patency rates [70, 71]. Another randomized trial showed longer patency with covered SEMS [72]. A meta-analysis concluded that covered SEMS have a significantly longer patency compared with uncovered SEMS [73]. However, a subsequent meta-analysis found no difference in patency between covered and uncovered SEMS at 6 and 12 months, although covered stents had a higher rate of stent migration [74].
Another concern for patients undergoing placement of a covered SEMS who have an intact gallbladder is the potential for developing cholecystitis due to obstruction of the cystic duct origin. Although the rate of developing cholecystitis as a complication after SEMS placement has been low in most studies, rates of up to 10 % have been reported [75, 76]. Some endoscopists routinely perform a biliary endoscopic sphincterotomy (B-ES) to facilitate SEMS placement and to help avert the risk of pancreatitis due to SEMS occlusion of the pancreatic duct. On the other hand, B-ES may itself be a risk factor for procedure-related complications including pancreatitis, bleeding, perforation, and stent migration. Studies comparing the outcome of SEMS placement in patients with and without a preceding B-ES have shown the following: (1) SEMS (covered and uncovered) may be placed without a B-ES with very high success rates equal to those who underwent B-ES prior to stent placement, (2) Avoiding a B-ES prior to SEMS placement may reduce the risk of complications, especially short-term complications such as bleeding and perforation [77, 78].
EUS-Guided Biliary Drainage
Despite a success rate of >90 % in most reports, ERCP with stent placement for malignant biliary obstruction occasionally fails owing to anatomical or technical problems. Surgically altered anatomy, gastric outlet obstruction, tumor infiltration of the ampulla, and periampullary diverticula may result in inability to reach or visualize the ampulla during ERCP. PTBD or surgical interventions are conventionally performed after unsuccessful ERCP. EUS-guided biliary drainage (EUS-BD) has recently emerged as an effective biliary drainage technique in cases of unsuccessful ERCP. Following the first report of EUS-BD by Giovannini et al. in 2001 [79], many groups have subsequently reported on the efficacy of EUS-BD as an alternative biliary drainage modality after unsuccessful ERCP [80–88]. EUS-BD is accomplished using one of three techniques. Transluminal biliary drainage involves accessing the common duct or a dilated left intrahepatic duct under EUS guidance, followed by dilation of the tract and placement of a stent between the common duct and duodenum (cholecystoduodenostomy) or the stomach and a left hepatic lobe duct (hepaticogastrostomy). The stent drains the biliary tree into the GI tract without crossing the site of biliary obstruction. In the EUS-BD rendezvous procedure, the biliary tree is accessed via the common duct or a left hepatic lobe duct and a guidewire is passed via the bile duct across the papilla into the duodenum. The EUS-placed duodenal guidewire is then used to perform ERCP in the usual retrograde fashion. It should be noted that the EUS guided rendezvous technique is possible only when the papilla can be reached endoscopically. With the EUS-guided antegrade technique, transgastric puncture of a dilated intrahepatic duct is performed followed by tract dilation and transpapillary placement a stent across the level of obstruction in antegrade fashion. The antegrade technique may be useful when the papilla cannot be reached endoscopically. EUS-BD is a technically complex procedure requiring advanced skills in interventional EUS. The overall success and complication rates are approximately 81 % and 15 %, respectively, in expert hands [47].
Efficacy of Preoperative Biliary Drainage
The benefit of PBD prior to pancreaticoduodenectomy in patients with resectable pancreatic cancer remains controversial despite numerous studies which have addressed this issue. Although several studies have suggested more perioperative complications in patients who underwent PBD, this approach remains popular in clinical practice. A recent study found that the use of preoperative biliary stenting doubled between 1992 and 2007, with most patients undergoing stent placement prior to surgical consultation [89]. Another study which evaluated the current clinical practice in pancreatic cancer surgery at German community and university hospitals found that of 102 returned questionnaires, 54 % preferred preoperative drainage procedures for cholestasis [90].
Several meta-analyses have evaluated the impact of PBD on the surgical outcome of patients with malignant obstructive jaundice undergoing pancreaticoduodenectomy [91–98] (Table 4.1). A 2002 meta-analysis by Sewnath et al. included 5 randomized control trials (RCTs) and 18 retrospective studies (RS) published from 1966 to 2001 [94]. They found that patients who underwent PBD had significantly higher overall complications (mainly PBD-related), prolonged hospital stays, and no difference in mortality compared to patients who went directly to surgery. This data led to the conclusion that PBD carries no benefit and should not be performed routinely. A second meta-analysis published in the same year which included two RCTs and eight RS concluded that preoperative biliary stent placement had neither a positive or adverse effect on surgical outcomes for patients with pancreatic cancer [93]. Velanovich et al. evaluated 1 RCT and 15 cohort studies, concluding that PBD increased postoperative wound infections by about 5 % but did not promote or protect from other complications [95]. Similarly, Garcea et al. found that PBD significantly increases the rates of bile culture positivity for bacteria and the probability of wound infection [91]. Otherwise, no evidence was found that PBD directly increases morbidity and mortality. Another meta-analysis in 2011 which reviewed 14 RS found no difference in overall postoperative complications or mortality between patients with or without PBD [92]. The authors concluded that PBD should not be used routinely for malignant obstructive jaundice. Fang et al. published a Cochrane review in 2012 which updated their previous meta-analysis from 2008 [96, 97]. Six RCTs were evaluated with 520 patients randomized (PBD-265, no PBD-255). They found no difference in mortality, but significantly higher serious morbidity in the PBD group vs. the direct surgery group. The study concluded that there is not sufficient evidence to support or refute routine PBD for patients with obstructive jaundice. Finally, a recent meta-analysis published in 2014 reviewed 14 studies (3 RCTs, 11 RS) comparing PBD using endoscopic stents (plastic or metal) vs. no drainage [98]. The study found no difference in overall mortality or morbidity between the PBD group and the nondrainage group. Interestingly, a subset of the drainage group which had PBD for <4 weeks had an increased overall morbidity by 7–23 %; however, morbidity with PBD for >4 weeks was not significantly different. The authors concluded that PBD should be used selectively, drainage times should be >4 weeks, and SEMS should be used rather than plastic stents. Overall, the published meta-analyses have not definitively demonstrated benefits of PBD on the surgical outcomes of patients with malignant jaundice undergoing pancreaticoduodenectomy. It is important to note that the studies evaluated in various meta-analyses had significant variability in methodology, including older studies, making the data difficult to interpret in light of recent improvements in endoscopic and surgical techniques [11, 99].
The question of whether jaundiced patients with resectable pancreatic head cancer should undergo PBD or proceed directly to surgery was addressed by a recent large multicenter RCT involving community and academic hospitals [100]. Patients with obstructive jaundice and serum bilirubin levels ranging from 2.3 to 14.6 mg/dL were randomized to undergo either endoscopic placement of a plastic biliary stent followed by surgery 4–6 weeks later, or surgery alone within 1 week after diagnosis. The primary outcome was the rate of serious complications within 120 days after randomization. The reported rates of serious complications was 39 % in the early-surgery group vs. 74 % in the PBD group (p < 0.001). Although PBD was technically successful in 94 % after one or more attempts, the reported failure rate during the initial ERCP was 25 %. Of note, 46 % of patients in the PBD group experienced procedure-related complications such as pancreatitis (7 %), cholangitis (26 %), perforation (2 %), and bleeding (2 %). Surgery-related complications (e.g., infections, bleeding, anastomotic leaks) occurred in 37 % in the early surgery group and 47 % in the PBD group (p = 0.14). Mortality and length of hospital stay did not differ between the two groups. These results show that patients undergoing PBD have a higher overall complication rate, mainly as a consequence of the PBD procedure itself, and suggest that routine PBD should not be performed. As noted by Baron and Kozarek, the initial ERCP failure rate (25 %) and the procedural complication rate (46 %) reported in this RCT was much higher than reported in most studies for these outcomes (typically 5–10 % for both) [101]. The unexpectedly high rate of cholangitis (26 %) and need for stent exchanges (30 %) in the PBD group during the 4–6 weeks prior to planned surgery can likely be attributed to the use of plastic stents rather than SEMS in this study. As noted previously, multiple studies have shown that SEMS have a superior patency compared to plastic stents and can be used safely in patients who eventually undergo pancreaticoduodenectomy.
Summary and Conclusions
Although EUS with FNA is more sensitive than ERCP for tissue diagnosis of pancreatic cancer, many patients with obstructive jaundice continue to undergo ERCP as the initial procedure. A focal stricture seen in the bile duct and/or pancreatic duct during ERCP in a jaundiced patient should raise suspicion for malignancy and is an opportunity for tissue sampling via brush cytology, forceps biopsy, or both. Using a combination of sampling methods increases sensitivity.
The primary rationale of PBD is to reverse the adverse consequences of biliary obstruction on various organ systems (e.g., immune function, coagulation, renal, cardiovascular) with a goal of reducing complications after major hepatobiliary surgery. However, most clinical trials and numerous meta-analyses have not shown a clear benefit of PBD as a routine procedure for patients with resectable pancreatic cancer who are otherwise able to proceed directly to surgery. The most recent RCT found an alarming rate of PBD-related complications, suggesting that PBD should not be performed routinely [100]. Improved technique and referral of patients to specialized centers with greater expertise could potentially lower the intrinsic risks of PBD.
Despite the controversy regarding its use, selected patients with obstructive jaundice due to resectable or borderline resectable pancreatic could still potentially benefit from PBD (Fig. 4.11). Although acute cholangitis is unusual in malignant obstructive jaundice in the absence of prior biliary intervention, patients who present with cholangitis should undergo urgent biliary decompression [43, 102]. Patients who have surgery delayed due to logistical reasons and those who require medical optimization or further staging should be considered for PBD. Finally, patients who undergo neoadjuvant chemoradiation therapy for borderline resectable pancreatic cancer or as part of treatment protocols may be candidates for PBD as a temporizing measure. In such cases, ERCP with insertion of a short SEMS is the preferred modality. Percutaneous biliary drainage procedures should be reserved for situations when endoscopic stent placement is unsuccessful. EUS-BD is also a feasible salvage technique for unsuccessful ERCP but is currently limited to centers with expertise in therapeutic endoscopy. Multidisciplinary treatment planning should be utilized whenever possible.
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Smith, M.T. (2016). Endoscopic and Percutaneous Biliary Drainage Procedures: Role in Preoperative Management, Diagnosis, and Palliation. In: Katz, M., Ahmad, S. (eds) Multimodality Management of Borderline Resectable Pancreatic Cancer. Springer, Cham. https://doi.org/10.1007/978-3-319-22780-1_4
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