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 21 November 2017

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Editor: Peter B. Cotton

4. The role of ERCP in pancreatico-biliary malignancies

Gulshan Parasher & John G. Lee

Top of page Synopsis  Next section

Approximately 30 000 new cases of pancreatic cancer and 7000 biliary tract cancers are diagnosed annually in the United States [1]. The most common cause of malignant biliary obstruction is pancreatic adenocarcinoma, followed by cholangiocarcinoma, ampullary neoplasm, and extrinsic compression by metastatic lymphadenopathy in the liver hilum. The role of ERCP in pancreatico-biliary malignancies is to [1] confirm diagnosis of obstructive jaundice in patients with suspected pancreatic carcinoma or biliary tumors [2]; obtain tissue for histopathologic diagnosis [3]; establish the exact site of obstruction, i.e. ampullary, pancreatic, or bile duct [4]; decompress the bile duct; and [5] facilitate palliative therapy such as intraluminal brachytherapy or intraductal photodynamic therapy. This review describes various current and emerging applications of ERCP in the management of pancreatico-biliary malignancies.

Top of page ERCP in diagnosis of pancreatico-biliary malignancies  Previous section Next section

Radiological diagnosis  Previous section Next section

Significance of 'double duct stricture' sign  Previous section Next section

The radiographic features of ERCP cannot reliably distinguish between benign and malignant diseases. Although the double duct sign with simultaneous narrowing of the common bile duct and the pancreatic duct has been regarded traditionally as predictive of pancreatic cancer (Fig. 1) recent studies showed that its specificity is much lower than previously thought, with 15–37% of such patients having benign disease on long-term follow-up [2,3]. Stricture length > 14 mm was highly predictive of malignancy in one study [4] while in another study the pancreatic duct stricture length measured on ERCP correlated with both size (P < 0.001) and staging (P < 0.002) of the pancreatic cancer [5]. The cholangiographic appearance was non-specific as benign-appearing strictures were usually found to be malignant on follow-up [4].

Tissue diagnosis  Previous section Next section

Histopathological confirmation of pancreatico-biliary malignancy permits more accurate decision-making with reference to comprehensive management including the potential use of radiation and/or chemotherapy.

Brush cytology, biopsy, and FNA  Previous section Next section

Endoscopic wire-guided brush cytology and endoscopic needle aspiration or forceps biopsy can be successfully performed during ERCP for cytological diagnosis (Fig. 2). Wire-guided brushing cytology is performed initially by passing the cytology catheter sheath beyond the proximal margin of the stricture; the brush is then advanced out of the sheath. The brush and sheath are then withdrawn to the distal margin of the stricture and the brush is passed back and forth across the stricture.

Earlier studies of brush cytology (usually from the bile duct) showed sensitivity of approximately 40% and specificity of 100% for diagnosis of malignancy [6,7]. Sampling of both ducts and dilating the bile duct stricture before brushing have been shown to improve the sensitivity of diagnosing pancreatic and biliary cancers to approximately 50–70% in several studies [8,9]. Pancreatic duct brushing appears to be safe without an increased risk of pancreatitis in these studies.

Finally, combining the results of brush cytology, fine needle aspiration, and/or forceps biopsy improves the overall sensitivity of ERCP in diagnosing pancreatic and biliary cancers to 70–85%, which is higher than any single method of tissue sampling [10–12]. We recommend performing at least two different types of tissue sampling procedures to improve the diagnostic accuracy of ERCP in patients with suspected pancreatico-biliary cancers.

Tumor markers in bile or pancreatic juice  Previous section Next section

A number of molecular and genetic markers have been studied alone or in combination in bile or pancreatic juice for the diagnosis of pancreatico-biliary malignancies (Fig. 3). Molecular-based tests may be helpful in diagnosing pancreatic cancer and other biliary malignancy at an early stage when surgical cure is still possible. Addition of DNA image analysis to routine cytology has been reported to increase the diagnostic sensitivity as compared to results of cytology alone [13]. Other studies focused their attention on mutations in codon 12 of the K-ras oncogene, because they are seen in up to 95% of pancreatic adenocarcinoma and in the premalignant conditions of the pancreas [14–16]. Bile obtained during ERCP can yield positive results in K-ras mutational analysis, even when results of conventional bile cytology are negative. One study reported a sensitivity of 33%, and specificity and positive predictive value of 100%, for the diagnosis of malignancy by K-ras mutational analysis in bile samples obtained during ERCP [15].

Most recent studies, however, suggest that K-ras mutational analysis is not specific for the diagnosis of pancreatic cancer as this mutation is also seen in a number of patients with chronic pancreatitis [16,17]. The specificity of K-ras mutational analysis may be increased by additional molecular genetic analysis. For example combination of K-ras mutation and telomerase activity or p53 immunostaining has been reported to increase the specificity for diagnosis of cancer to 100% [18,19]. Another study showed that detection of antigen 90K in pancreatic juice in combination with serum CA 19–9 correctly identified 84.2% of pancreatic cancers and 90% of chronic pancreatitis cases [20]. In conclusion, the presence of K-ras mutations in pancreatic juice (and other material obtained during ERCP) is not specific enough to justify its use in clinical practice. Although combining K-ras mutational analysis with other tumor markers such as p53 and telomerase may further increase its specificity, the sparse data available are preliminary and therefore such analysis should be considered investigational at this time.

Top of page Direct endoscopic examination of pancreatico-biliary malignancies  Previous section Next section

Choledochoscopy  Previous section Next section

Choledochoscopy using the mother and baby scope system is used to visualize the bile duct, obtain specimens, and to treat stones and tumors [21]. In a series of 61 patients who underwent choledochoscopy for various indications, three patients with suspected choledocholithiasis were diagnosed with benign epithelioid tumor, large cell lymphoma, and cholangiocarcinoma [22]. Of six patients with suspected cholangiocarcinoma, four had cholangiocarcinoma, one had ampullary cancer, and one had an eroding surgical suture. Choledochoscopy showed intraductal metastasis from colorectal cancer, bleeding hepatoma, cholangiocarcinoma, and angiodysplasia of the bile duct in four patients with hemobilia. Finally, choledochoscopy-guided ND:YAG laser was used to debulk tumor ingrowth in several patients with blocked Wallstents [22].

Pancreatoscopy  Previous section Next section

Pancreatoscopy has been shown to be an effective tool in the diagnosis of cystadenoma and cystadenocarcinoma of the pancreas [23–25]. Pancreatoscopy was successful in 30 of 41 patients (73.2%) and showed villous or vegetative elevations in patients with dysplastic adenoma or adenocarcinoma. Pancreatoscopy led to partial resection in 7 of 30 patients with non-malignant tumors resulting in favorable outcomes [26]. Pancreatoscopy was also useful for detecting and distinguishing benign from malignant intraductal papillary mucinous tumor (IPMT) and in determining the extent of tumor involvement of the main pancreatic duct in planning for resection [25–27].

Top of page Intraductal ultrasound [IDUS]  Previous section Next section

IDUS is performed by selectively cannulating the bile duct using a 6 French gauge, high-frequency (20 MHz) mini-probe during ERCP. This technique can visualize the extra hepatic and right and left intrahepatic ducts and is useful for performing tumor staging during the initial ERCP. IDUS can assess portal vein and right hepatic artery invasion at the liver hilum and is more accurate than conventional endoscopic ultrasound (EUS) in assessing pancreatic parenchymal invasion by bile duct cancer [28].

IDUS has been used in combination with other methods to increase the diagnostic yield for cancer. In one study, a combination of peroral pancreatoscopy and IDUS was helpful in differentiating malignant from benign IPMT and resulted in an improvement in postoperative survival [27]. Tamada et al. showed that the presence of sessile tumor, tumor size > 1 cm, and interrupted wall structures was helpful in predicting malignancy in 62 patients with malignant biliary strictures and prior negative biopsies [29].

Top of page Magnetic resonance cholangiopancreatography  Previous section Next section

Magnetic resonance cholangiopancreatography (MRCP) is an emerging application of magnetic resonance imaging (MRI) applied to the pancreatico-biliary tree. MRCP relies on heavily T2–weighted sequences. Fluid-containing structures have a much longer T2 than solid tissue, resulting in higher signal intensity. Stationary fluid in the biliary and pancreatic ducts serves as an intrinsic contrast medium and the ductal system appears white against a black background, similar to ERCP.

MRCP vs. ERCP  Previous section Next section

The major advantages of MRCP are that it does not require endoscopy, contrast injection, or exposure to radiation. MRCP has been reported to distinguish between benign and malignant bile duct obstruction, with sensitivity between 50 and 86% and specificity between 92 and 98% [30–32]. MRCP has been reported to be similar to ERCP in distinguishing between malignant and benign biliary obstruction with respect to sensitivity (86% vs. 89%), specificity (82% vs. 94%), and likelihood ratios for positive (4.9 vs. 15.1) and negative tests (0.2 vs. 0.1), respectively [32].

In another comparative study, the sensitivity of ERCP for diagnosing pancreatic cancer was lower (70% vs. 84%) because it missed 11 lesions < 3 cm, most of which were in the head of the pancreas [33]. ERCP was associated with several mild cases of pancreatitis, fever, and epigastric pain while MRCP was free of complications [33]. MRCP is also helpful in visualizing the main pancreatic duct in patients with IPMT, especially when ERCP fails because of copious intraductal mucin [34].

Finally, MRCP can be used to confirm the presence and location of a biliary stricture in a patient with obstructive jaundice before therapeutic ERCP, particularly in those with complex hilar lesions, thus minimizing the risk of contamination and infection. MRCP-guided endoscopic unilateral stent placement was associated with lower morbidity and mortality as compared with standard method of stent insertion in 35 patients with Bismuth types III and IV hilar tumors [35].

In conclusion, MRCP is a safe, non-invasive, and accurate, but operator-dependent technique for imaging the pancreatico-biliary system. MRCP should be used instead of purely diagnostic ERCP when available and before attempting stenting in patients with hilar strictures.

Top of page Palliation of inoperable pancreatico-biliary malignancies  Previous section Next section

ERCP is the preferred method of palliating patients with malignant obstructive jaundice. Successful biliary drainage by endoscopic stenting can be achieved in more than 90% of patients with low procedure-related morbidity and mortality [36,37]. Although only surgery offers potential for a cure, endoscopic palliation continues to remain the therapeutic goal in most patients, because the majority of pancreatico-biliary cancers present at an advanced stage in elderly patients, who are poor surgical candidates. Several randomized trials comparing surgical bypass to endoscopic stenting in patients with unresectable lesions showed similar success rates for biliary decompression and overall survival, but lower morbidity and 30-day mortality for the ERCP-treated patients [36–38].

ERCP also reduced the cost and shortened hospital stay (P < 0.001) compared to surgery [39] and improved the quality of life [40]. Although the percutaneous approach is another alternative to ERCP for biliary drainage, it should be reserved for patients with duodenal obstruction or failed ERCP, because a randomized comparative study showed it to be less successful and causing more complications compared to ERCP [41]. Pancreatic duct stenting has been reported to be helpful in relieving 'obstructive' pain from pancreatic cancer in some patients [42]. In conclusion, endoscopic palliation is highly successful, has a lower morbidity and mortality, and costs less compared with other approaches to pancreatico-biliary malignancies.

Endoscopic stenting for malignant jaundice  Previous section Next section

Technique of endoscopic stent insertion  Previous section Next section

ERCP and endoscopic stent insertion require deep cannulation of the common bile duct with a catheter and guidewire. A diagnostic ERCP is mandatory prior to stent insertion to evaluate the pancreatico-biliary system. The length and the location of the stricture should be carefully determined and the proximal biliary tree should be assessed.

The procedure may prove to be technically difficult in cases where tumors distort the duodenal or the ampullary anatomy. The stent is usually placed through a therapeutic duodenoscope with an instrument channel of at least 4 mm. A prior sphincterotomy is usually only needed for placement of multiple large stents or to facilitate future stent exchanges in patients with difficult access. Difficult cannulation at times may require precutting of the ampulla using a needle knife sphincterotome (needle knife sphincterotomy) to gain access into the biliary system.

Dilatation prior to stent insertion is required only for extremely tight strictures, but we recommend routinely dilating hilar strictures prior to stenting (Fig. 4).

For insertion of a plastic stent, a basic three-layer coaxial system consisting of a 0.035-inch guidewire and a 6 Fr guiding catheter is used. These are placed sequentially across the stricture and the stent is deployed with the help of a pusher tube. A modified stenting system (OASIS, Wilson Cook) combines the pusher and inner catheter into one system to minimize the number of exchanges. In patients with bifurcation obstruction, two wires should be placed first into the right and left systems, before attempting double stenting into the right and left hepatic ducts.

Types of stents  Previous section Next section

Plastic stents  Previous section Next section

Plastic stents are mostly made of polyethylene. Other materials used are polyurethane and Teflon. The mean patency of a plastic stent is approximately 2–4 months [43,44]. Important complications associated with plastic stents include stent occlusion, sepsis, stent migration, stent fracture, and, rarely, acute cholecystitis related to occlusion of the cystic duct [44].

The major disadvantage of plastic stents is occlusion from bacterial biofilm, which is comprised of protein, deconjugated bilirubin, microcolonies of bacteria, and amorphous debris [43]. Stent occlusion leads to recurrence of jaundice or cholangitis, necessitating stent exchanges in 30–60% of patients [43–45]. Unfortunately, attempts to improve the patency rates of plastic stents by alternative stent design, oral administration of bile acids, antibiotics, and aspirin have not been clinically successful [43–49].

Metal stents  Previous section Next section

The self-expandable metal stent (SEMS) was developed to overcome the short patency of the plastic stent. SEMSs are made of either stainless steel alloy monofilaments (Wallstent, Boston Scientific, Natick, MA and Spiral Z stent, Wilson Cook, Winston Salem, NC) or nickel titanium alloy (Diamond Stent, Boston Scientific, Natick, MA and Za stent, Wilson Cook, Winston Salem, NC).

The comparative efficacy of each design is not well known and their use is guided more by physician preference. SEMSs can be compressed on to a 3-mm delivery system and expanded to 10 mm after deployment. The larger luminal diameter of these stents offers a prolonged patency of up to 10–12 months. However, the cost per device is significantly higher than plastic stents ($1000–1500 vs. $50–100).

SEMSs can also occlude but through different mechanisms, including biliary sludge, dietary fiber, tumor ingrowth or overgrowth, epithelial hyperplasia, or a combination of these. Management of an occluded metal biliary stent includes mechanical dislodgement of the obstructing material, placement of a plastic stent within the metal stent, and placement of a second overlying or overlapping stent to improve drainage. Electrocoagulation or laser therapy to destroy the ingrowing tumor has not been effective [44].

Metal vs. plastic stents  Previous section Next section

Metal stents have been compared with plastic stents in different studies. In 47 patients with pancreatic cancer with a mean survival of 6.2 months from the time of endoscopy, metal stents were shown to have a longer patency than plastic stents—8.2 months vs. 3.5 months (P < 0.001) [50].

A prospective randomized trial in France evaluated 97 patients with malignant strictures of the bile ducts (64% with pancreatic cancer), who were randomized to receive either an 11.5 Fr stent to be exchanged on demand or every 3 months, or a self-expanding metallic wall stent [51]. Mean duration of follow-up was 166 days. Cost effective analysis suggested that metal stents were advantageous for patients surviving longer than 6 months, whereas plastic stents were advantageous for patients surviving less than 6 months. This study showed initial metal stenting to be the most cost effective approach, provided that the patient survived for longer than 6 months.

The US Wallstent multicenter randomized trial evaluated the Wallstent compared with 10F plastic stents for the palliation of malignant biliary obstruction [52]. Early stent occlusion was reported in 30% of the plastic group and in 0% of the Wallstent group. Sludge occlusion and stent migration were seen in 28% of plastic stents and 6% of Wallstents. The overall complication rate was significantly lower in the Wallstent group (P < 0.05) for both hilar and distal biliary strictures. Wallstents did not offer any survival advantage over the plastic stent but were less expensive because they required fewer repeat ERCPs and stent exchange.

A prospective study from Amsterdam compared Wallstents with plastic stents in distal malignant biliary obstruction and reported a lower occlusion rate (33% vs. 54%), longer stent patency (273 vs. 126 days), and 28% reductions in ERCPs per patients in the Wallstent group [53]. These studies show that Wallstents can be deployed successfully in most patients and occlude less frequently and less rapidly than the conventional 10 Fr and 11.5 Fr plastic stents.

Logically, therefore, Wallstent use reduces hospitalization and repeated interventions leading to a lower cost. In conclusion, the most cost effective approach to palliating malignant obstructive jaundice is to place a SEMS at the initial ERCP in patients with unresectable cancer who have a life expectancy of at least 6 months.

Covered and uncovered metal stents  Previous section Next section

Metal stents partially covered with silicone or polyurethane membrane have been introduced to overcome the problem of tumor ingrowth and epithelial hyperplasia. Shim et al. compared endoscopically placed polyurethane-covered Z-stent to non-coated Wallstent or Strecker stent [55]. The median patency of both covered and uncovered stents was comparable (267 vs. 233 days), but tumor ingrowth was seen in two patients with the covered stents compared to six in the non-covered stent group. Early and late complications were the same in both groups [54].

Reported complications associated with covered stents include tumor ingrowth or overgrowth, sludge accumulation, stent migration, pancreatitis, and gangrenous cholecystitis [44,54–56]. Finally, covered biliary metal stents have not uniformly shown a significant advantage in terms of greater patency rates [54,56].

Biodegradable stents  Previous section Next section

Self-expanding mesh stents made of biodegradable materials behave similarly to their wire mesh counterparts, but disintegrate and disappear over time. Polylactic acid is used in one such bioabsorbable stent. Post implantation, body heat and water degrade the polymer to lactic acid, then via the Krebs cycle to CO2 and H2O.

Animal studies of the canine bile duct using the bioabsorbable biliary mesh stent made from polylactic acid have shown that the stent becomes embedded within the bile duct epithelium within 1 month of implantation [57]. There was minimal inflammatory reaction after 6 months and the histology reverted to baseline, with complete disintegration of the stent after 2 years. These stents offer long-term palliation without precluding subsequent resection in patients with suspected but unproven malignant stricture, or for those in whom curative resection is unlikely but not ruled out. The exciting potential applications in the future for these devices include delivery of chemotherapeutic agents or cellular gene therapy and tissue remodeling.

Endoscopic stenting for hilar strictures  Previous section Next section

Most malignant hilar strictures are related to cholangiocarcinoma, metastatic lymphadenopathy, large pancreatic cancer, or gallbladder carcinoma [58–61]. Hilar lesions or Klatskin tumors are classified according to the degree of involvement of the intrahepatic ducts [58].

Bismuth classification for hilar obstruction  Previous section Next section

Bismuth type I tumors involve the common hepatic duct, type II involve the right and left intrahepatic ducts, type III involve either the right (IIIA) or left (IIIB) secondary intrahepatic ducts, and type IV involve the secondary intrahepatic ducts bilaterally. Palliation of hilar strictures involving the bifurcation or its branches (Bismuth types II or type III) is technically difficult. Cholangitis can develop after ERCP in 0–40% of patients, depending on the complexity of the lesion and completeness of drainage [59].

Unilateral vs bilateral drainage for hilar obstruction  Previous section Next section

There is considerable debate in the literature about whether unilateral drainage is sufficient in patients with hilar strictures. Deviere et al. suggested draining both of the obstructed lobes in types II and III hilar lesions to maximize reduction in bilirubin and reduce the likelihood of developing cholangitis [60] (Fig. 5) They showed a decrease in biliary sepsis rate from 38% to 17% and an increase in the survival in types II and type III strictures from a mean of 119 days to 176 days by performing bilateral stenting [60].

Others recommend unilateral stenting as long as one-quarter to one-third of the liver volume is drained by the single endoprosthesis, leaving the option of a second stent for the 20% who do not respond favorably [61,62]. Polydorou et al. evaluated this selective approach in 190 consecutive patients with hilar malignancies [62].

A single prosthesis was placed in 89% of patients with successful drainage in 82%; 4% had additional stents due to insufficient response. Seven per cent required a combined procedure with percutaneous transhepatic access. Stenting was technically successful in 93% of type 1, 94% of type II, and 84% of type III patients, with successful drainage in 91%, 83%, and 73% of patients, respectively. Early complications were seen in 7%, 14%, and 31% of types I, II, and III patients, and the mortality rates for these groups were 14%, 15%, and 32%, respectively [62]. The authors concluded that a single prosthesis provides good palliation in 80% of the patients, whereas a second stent should be reserved for stent failures. A small prospective randomized comparative trial showed significantly higher technical success and lower complication for patients treated by unilateral stenting [63].

Another study recommended bilobar drainage in patients when both of the lobes were filled during the ERCP, as patients with incomplete drainage had the worst survival among all patients with hilar tumors [64]. All things being equal, it probably makes more sense to drain the left system because the left hepatic duct has fewer side branches near the hilum, but this anatomical advantage has not been clearly proven to confer any clinical benefit [61].

In our opinion, the most elegant and physiological approach to stenting hilar tumor is to first map the lesion using MRCP and document its function using CT prior to determining which duct to stent. With these data in hand, it may be possible to selectively cannulate and stent the desired duct without contaminating the other ducts. Both plastic and SEMSs have been used for palliation of hilar malignancies with varying success and complication rates [61–64].

Metal stents in hilar strictures have the advantage over plastic stents in ease of insertion and drainage of side branches through the stent meshwork. If both lobes of the liver should be drained, two SEMSs can be placed either endoscopically or percutaneously, most often fashioned into a Y configuration or placed parallel to each other.

Other techniques of endoscopic palliation  Previous section Next section

Intraductal photodynamic therapy  Previous section Next section

Photodynamic therapy involves intravenous administration of a photosensitizing compound, usually a hematoporphyrin derivative that preferentially accumulates within the tumor cells, followed by activation using laser lights. This releases reactive oxygen species leading to tumor necrosis. Photodynamic therapy has been studied in cholangiocarcinoma as the cancer cells have been shown to be sensitive to photodynamic therapy. Photofrin 11 (Porfimer sodium) and 5-aminolevulinic acid (5-ALA) have been studied in humans [65,66]. These drugs are given intravenously and 24 to 48 h later endoscopic or percutaneous transhepatic cholangiography is performed and biliary catheters are advanced through the working channel of the duodenoscope and placed across the malignant stricture. Subsequently flexible laser fibers are advanced through the biliary catheters. The tumor is treated sequentially from proximal to distal margin. Laser light (630 nm) is delivered to activate the Photofrin with a total energy of 180 J/cm2.

One study evaluated PDT for cholangiocarcinoma in patients with unresectable Bismuth types III and IV tumors, who had an inadequate decrease in bilirubin despite adequate biliary stent placement [65]. The patients received up to three monthly treatments. Patients had a significant decrease in serum bilirubin and improvement in the quality of life, including on the Karnofsky index, WHO index, and biliary obstruction scale and improved survival. However, another recent study did not show any benefit to intraductal PDT using 5-ALA in patients with unresectable cholangiocarcinoma [66]. An important toxicity associated with photodynamic therapy is photosensitization, which occurs in 20–40% of patients [67] despite avoidance of sunlight. Less common side-effects include infusion reaction and stricture, and fistula formation in the treated areas [68,69].

Brachytherapy  Previous section Next section

Brachytherapy involves the intracavitary placement of a radioactive source within a malignant stricture. 192Ir has been studied in patients with cholangiocarcinoma to improve stent patency and survival. Intraluminal brachytherapy can be accomplished either endoscopically via a previously placed nasobiliary tube or by the percutaneous transhepatic route [70–73].

Radiation therapy is then applied to the area in calculated doses depending on the various radiation therapy protocols. Patients are hospitalized and given either low-dose brachytherapy using 30–45 Gy (3000–4500 rad) over 24–60 h or high-dose brachytherapy as an outpatient. In certain cases radiosensitizing chemotherapeutic agents such as 5 Flurouracil (5 FU) are also administered simultaneously [70]. Effective biliary drainage is maintained after treatment using plastic or metal stents. Important early complications include cholangitis and duodenal ulcers, and less common long-term complications include biliary enteric fistula and hematobilia [71,72]. Brachytherapy should be administered as part of an experimental protocol, because available data are preliminary and based on treatment of very few patients, with only questionable benefit in survival [66,73].

Top of page ERCP in management of ampullary neoplasms  Previous section Next section

Benign tumors  Previous section Next section

A number of benign tumors arise at the major papilla, including adenoma, lipoma, leiomyoma, lymphangioma, and hamartoma. Amongst these lesions adenoma is the most common benign but premalignant tumor. These tumors can cause symptoms of biliary colic, obstructive jaundice, recurrent pancreatitis, and, rarely, gastrointestinal bleeding [74–76]. Ampullary adenoma may be sporadic or occur as part of familial adenomatous polyposis (FAP) and Gardner's syndrome [75]. Ampullary adenoma may contain foci of adenocarcinoma [74–76] and can be excised surgically or endoscopically in many instances.

The surgical options include transduodenal local excision and pancreatico-duodenectomy [74].

Endoscopic treatment involves the combination of snare excision and thermal ablation. ERCP should be performed before ampullectomy to identify intraductal extension and to rule out other intraductal lesions. Tissue sampling after biliary sphincterotomy may increase the diagnostic yield for cancer [74,78]. There is accumulating evidence that endoscopic resection, ablation, or both, performed by an experienced endoscopist is a safe and effective treatment for sporadic or FAP-associated periampullary adenoma [77,78].

Endoscopic snare papillectomy is indicated for tumor size < 4 cm without evidence of malignancy as suggested by endoscopic and histological findings, and absence of intraductal extension on ERCP or EUS. Ampullectomy is performed by snare resection using blended electrosurgical current either en bloc or in a piecemeal fashion [79].

Some suggest placing pancreatic stents in all patients after snare papillectomy; however, others advocate performing stenting only when the pancreatic duct fails to drain after papillectomy [77,78]. In general, extension of the adenoma into either duct warrants surgical excision, because of the increased likelihood of carcinoma and the difficulty of endoscopic excision.

Ampullary carcinoma  Previous section Next section

The role of endoscopic treatment of ampullary carcinoma is to adequately palliate those patients unsuitable for surgery using endoscopic sphincterotomy with stent insertion to relieve obstructive jaundice. In select patients a large sphincterotomy may provide adequate drainage without a stent. Endoscopic palliation can then be achieved by a combination of snare excision and Nd:YAG laser ablation of the tumor tissue. ERCP-assisted ablation of ampullary neoplasm using ultra high-frequency ultrasound probes may be a promising alternative to thermal ablation in the future [80]. Finally, application of new imaging methods during ERCP, such as optical coherence tomography (OCT), may lead to improved diagnostic accuracy of ampullary neoplasm. One recent study reported preliminary experience with this technique in five patients, with OCT identifying the characteristic epithelial morphology in two cases of papillary cholangiocarcinoma [81].

Top of page Outstanding issues and future trends  Previous section Next section

The management of pancreatico-biliary malignancies involves a multidisciplinary approach combining the expertise of the gastroenterologists, radiologists, and surgeons. ERCP is an important diagnostic and therapeutic modality and plays a crucial role in the management of these patients. Emerging newer diagnostic modalities are helpful in defining the finite role of ERCP in the management of pancreatico-biliary malignancies.

At the present time ERCP is an effective, safe, and cost efficient treatment for the palliation of these tumors. ERCP in combination with EUS and FNA offers an effective means of tissue sampling. This coupled with the new molecular technology may improve the early diagnosis and staging of pancreatico-biliary malignancies. Although endoscopic stenting is an established palliation for malignant obstructive jaundice, major complications, including blockage of plastic stents by bacterial biofilm and biliary sludge, still limit its clinical benefits. Prolonged palliation of jaundice is achieved by the use of SEMSs but they too are limited by tissue and tumor ingrowth. Better innovations in technology and future studies will further widen the scope of this technique in the management of pancreatico-biliary malignancies.

Top of page References  Previous section

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Historical background
The changing world of pancreatic–biliary medicine
  The impact of scanning radiology
  Extending the indications for therapeutic ERCP
  Improvements in surgery
  Patient empowerment
  Current focus
Benefits and risks
  Degree of difficulty and expertise
  Report cards
  Unplanned events
  Clinical success and value
The future
  Imaging of the pancreatico-biliary system
   ERCP vs. PTC
Section I: Preparation for ERCP
  Room set-up and floor plan (Figs 1, 2)
   Position of monitors and endoscopy cart (Fig. 2)
  Essential equipment for ERCP
   Side-viewing duodenoscopes
   Forward-viewing scopes
   Sedatives and analgesics
   Smooth muscle relaxants
   Reversal agents
  Monitoring during conscious sedation
  Contrast agents
   Syringes for aspiration and irrigation
  Organization and storage of accessories (Fig. 4)
  Organization of the worktop (Fig. 5)
  Fluoroscopy for ERCP
   Fluoroscopy units (Fig. 6)
   KV and mA
   Split screen
   Magnified view
   Orientation of fluoroscopic images
   Personnel protection (Fig. 8)
   Other protective gear
   Positioning of the patient
  Radiological interpretation
   Scout film (Fig. 7)
   Contrast studies
   Drainage films
   The pancreatogram
   Normal anatomy
   Pathological changes
   Congenital anomalies
   The cholangiogram
   Normal anatomy
   Pathological strictures
   Bile duct stones (Fig. 11)
   Underfilling and delayed drainage
Section II: Diagnostic and therapeutic ERCP
  Diagnostic ERCP
   Accessories (Fig. 13)
   Preparation of patient
   Informed consent
  ERCP procedure
   Intubation and examination of the stomach
   Approaching the main papilla
   Cannulation of the papilla
   Ease and success in cannulation
   Minor papilla cannulation
  Complications of diagnostic ERCP
   Respiratory depression and other complications
  Failed cannulation and special situations
   What to do with a difficult intubation
   Failure to insert the duodenoscope
   Lost in the stomach
   Failure to identify the papilla
   Tip of endoscope is too proximal
   Tip of scope is too distal
   Obscured papilla
   What to do if cannulation is difficult
   Abnormal papilla
   Failed common duct cannulation
   Failed pancreatic duct cannulation
   Failed accessory (minor) papilla cannulation
   Failure to obtain get deep CBD cannulation
   Precut sphincterotomy to assist in CBD cannulation
   Needle-knife precut technique
   Selective cannulation of the intrahepatic system (IHBD)
   Cannulation of the papilla in a Billroth II situation(Fig. 17)
  Therapeutic ERCP
   Standard endoscopic sphincterotomy or papillotomy (Fig. 18)
   Preparation of patients
   Laboratory tests
   The sphincterotome (or papillotome)
   Electrosurgical unit
   Adequacy of sphincterotomy
   Wire-guided sphincterotomes
   Periampullary diverticula and sphincterotomy
   Distorted anatomy
   Precut sphincterotomy for impacted stone
   Indications for sphincterotomy and results
   Complications of sphincterotomy
   Post sphincterotomy bleeding
   What to do if the sphincterotomy fails to cut
   The risk of a half cut
   What to do with a deviated cut
   Sphincterotomy in Billroth II cases
   Stone extraction (Figs 19, 20)
   Endoscopic nasobiliary catheter drainage for bile duct obstruction (Fig. 24)
   Endoscopic plastic stent insertion for malignant biliary obstruction (Fig. 26)
   Preparation of patient
   One-step introducer system
   Bilateral stenting for hilar obstruction
   Brushing cytology for bile duct strictures (Fig. 27)
   Single-lumen system
   Double-lumen system
   Assessment of response to biliary stenting
   Results of biliary stenting
   Complications of stenting
   Early complications
   Late complications
   Self-expandable metal stents
   Stent configurations
   Lengths of stents
   Introducer system for SEMS
   Balloon dilation of biliary strictures (Fig. 28)
   Endoscopic management of bile leaks
Outstanding issues and future trends
  Incidence of CBD stones
  Traditional management
  Non-operative approach to CBD stones
  Classification of CBD stones
   Primary CBD stones
   Bacteriology of primary CBD stones
   Secondary CBD stones
Clinical presentations
  Asymptomatic biliary stones
  Symptomatic biliary stones
   Obstructive jaundice
   Clinical cholangitis
   Biliary pancreatitis
   Oriental cholangitis or recurrent pyogenic cholangitis
  Clinical diagnosis
   Abdominal ultrasound scan
   Endoscopic retrograde cholangiopancreatography (ERCP)
   Magnetic resonance cholangiogram (MRC) for CBD stones
   Endoscopic ultrasonography (EUS) for CBD stones
Management for CBD stones
  ERCP, sphincterotomy, and stone extraction
   Endoscopic sphincterotomy
   Choice of endoscopes
   Cannulation with sphincterotome
   Stone extraction
   Basket stone extraction
   Balloon stone extraction
  Acute pancreatitis
  Sphincterotomy vs. balloon sphincteroplasty
   Balloon sphincteroplasty
   Balloon sphincteroplasty for CBD stones
   Sphincterotomy for CBD stones
   Long-term complications of sphincterotomy
  ERCP vs. laparoscopic common duct exploration for retained CBD stones
   Preoperative ERCP
   Operative removal of CBD stones
   Factors that predict CBD stones
   MRC for detection of CBD stones
   Risk scores for prediction of CBD stones
Alternative approaches to CBD stones
  Precut sphincterotomy for failed deep cannulation
   Complications of precut sphincterotomy
  Percutaneous transhepatic cholangiogram and drainage
   Rendezvous procedure (two-hands technique)
   Percutaneous stone extraction
The challenge: giant CBD stones
  Basket mechanical lithotripsy (BML)
  Through-the-scope BML using a metal sheath
   Results of BML
  Mother and baby choledochoscopy and intraductal lithotripsy
   Electrohydraulic lithotripsy (EHL)
   Intraductal laser lithotripsy
  Stenting and interval endoscopic lithotripsy
   Effects of stenting on CBD stones
   The need for stone extraction after stenting
  Extracorporeal shock-wave lithotripsy (ESWL)
   Results of ESWL for CBD stones
  Open surgery
Intrahepatic duct stones
  ERCP and basket removal
  Wire-guided basket
  Percutaneous transhepatic cholangioscopy (PTC)
   Results of percutaneous treatment of intrahepatic stones
ERCP and sphincterotomy in Billroth II gastrectomy
  Precaution and alternatives for Billroth II gastrectomy
  Side-viewing vs. forward-viewing scope for ERCP in Billroth II gastrectomy
   Effect of biliary obstruction on the reticuloendothelial system
   Bacteriology of cholangitis
   Effect of raised intrabiliary pressure and cholangiovenous reflux
  Clinical presentation
   Simple cholangitis: Charcot's triad
   Suppurative cholangitis: Reynold's pentad
  Clinical management
   Initial conservative management
   Urgent biliary decompression
   Role of ERCP
   Endoscopic drainage vs. surgery
   ERCP vs. PTBD
   Nasobiliary catheter drainage vs. stenting in acute cholangitis
   Surgery to prevent recurrent cholangitis
   Types of operation
Outstanding issues and future trends
ERCP in diagnosis of pancreatico-biliary malignancies
  Radiological diagnosis
   Significance of 'double duct stricture' sign
  Tissue diagnosis
   Brush cytology, biopsy, and FNA
  Tumor markers in bile or pancreatic juice
Direct endoscopic examination of pancreatico-biliary malignancies
Intraductal ultrasound [IDUS]
Magnetic resonance cholangiopancreatography
Palliation of inoperable pancreatico-biliary malignancies
  Endoscopic stenting for malignant jaundice
   Technique of endoscopic stent insertion
   Types of stents
   Plastic stents
   Metal stents
   Metal vs. plastic stents
   Covered and uncovered metal stents
   Biodegradable stents
   Endoscopic stenting for hilar strictures
   Bismuth classification for hilar obstruction
   Unilateral vs bilateral drainage for hilar obstruction
  Other techniques of endoscopic palliation
   Intraductal photodynamic therapy
ERCP in management of ampullary neoplasms
  Benign tumors
   Ampullary carcinoma
Outstanding issues and future trends
Classification of bile duct injuries
Diagnostic protocol
Management of bile duct leakage after cholecystectomy
  Type A injury (peripheral leaks)
  Type B injury (main duct leaks)
  Type C injuries (postoperative biliary strictures)
  Type D injury (transections)
   Delayed reconstruction
Surgical treatment of postoperative biliary strictures
Percutaneous treatment of postoperative strictures
Endoscopic treatment of postoperative biliary strictures
  Reported results
  Phases of endoscopic treatment
   Stent insertion phase
   Stenting phase
   Follow-up phase
Postoperative biliary strictures: surgery or endoscopy [43]?
  Recurrent strictures after surgery
Metal stents for benign strictures
A more aggressive treatment protocol?
Outstanding issues and future trends
  Sphincter of Oddi dysfunction
  Sphincter of Oddi stenosis
Classification of SOD
  SOD in patients with gallbladder disease
  SOD after cholecystectomy
  SOD in the biliary or pancreatic sphincter, or both
  SOD and pancreatitis
Clinical presentation
  The Rome criteria
Initial evaluation
  Serum chemistries
  Standard imaging
Non-invasive diagnostic methods for SOD
  Morphine–prostigmin provocative test (Nardi test)
  Radiographic assessment of extrahepatic bile duct and main pancreatic duct diameter after secretory stimulation
   Ultrasound provocation testing
   Endoscopic ultrasound monitoring
   MRCP monitoring
  Quantitative hepatobiliary scintigraphy
   Adding morphine provocation
  Comparing non-invasive tests
  Current status of non-invasive methods
Invasive diagnostic methods for SOD
  Intraductal ultrasonography (IDUS)
Sphincter of Oddi manometry
  Sphincter of Oddi manometry: technique and indications
   Drug interactions
   Manometry catheters
   Cannulation techniques
   Study both sphincters
  Interpretation of manometry traces
   Normal values
  Complications of SOM
   Methods to reduce complications
   Aspirating catheter system
   Prophylactic stenting
  Sphincter of Oddi manometry; conclusion
   Type I patients
   Type II patients
   Type III patients
Therapy for sphincter of Oddi dysfunction
  Medical therapy
   Electrical nerve stimulation
  Surgical therapy
  Endoscopic balloon dilation and biliary stent trials
  Endoscopic sphincterotomy
   Randomized controlled trials of endoscopic sphincterotomy for SOD
   Is pancreatic sphincterotomy necessary?
  Risks and benefits of endoscopic treatment for SOD
  Botulinum toxin injection
Sphincter of Oddi dysfunction in recurrent pancreatitis
  Endoscopic sphincterotomy for SOD in pancreatitis
   Lans and colleagues
   Guelrud and colleagues
   Kaw and Brodmerkel
   Toouli and colleagues
   Okolo and colleagues
  Endoscopic sphincterotomy as a cause of pancreatic sphincter stenosis
  Endoscopic Botox injection
  SOD in recurrent pancreatitis: conclusion
Outstanding issues and future trends
Interdisciplinary management; complex ERCP
Acute gallstone pancreatitis
  Clinical diagnosis of acute gallstone pancreatitis
  Predicting severity of acute pancreatitis
  Acute treatment
  The role of early ERCP
   British study
   Hong Kong study
   Polish study
   German study
   Meta-analysis of studies of early ERCP, and current consensus
   ERCP is rarely indicated before cholecystectomy in patients with gallstone pancreatitis
   Acute pancreatitis postcholecystectomy
   Treatment by biliary sphincterotomy alone?
Pancreatic duct disruptions
  Stenting for duct disruption
Smoldering pancreatitis
Acute recurrent pancreatitis
  'Idiopathic' pancreatitis
  Microlithiasis and occult gallstones
   Detecting microlithiasis
   Bile crystals
   Empiric cholecystectomy?
  Sphincter of Oddi dysfunction (SOD)
   Diagnosis of SOD
   Endoscopic therapy for SOD
   Sphincterotomy without sphincter manometry?
   Is sphincter manometry dangerous?
   SOD in patients with intact gallbladders
  Pancreas divisum
   Does pancreas divisum cause pancreatitis?
   Endoscopic treatment for pancreas divisum
   Stenting for pancreas divisum
   Problems with endoscopic therapy
  Chronic pancreatitis (idiopathic, alcohol, familial, other)
   Endoscopic therapy for chronic pancreatitis
  Pancreatitis due to neoplastic obstruction
   Endoscopic management of neoplastic obstruction
   Stenting for smoldering pancreatitis due to malignancy
  Other rare causes of pancreatitis
Overall approach to unexplained acute pancreatitis
  Concerns about ERCP and empiric sphincterotomy in recurrent acute pancreatitis
   Risks of ERCP
  Investigations other than ERCP
  Recommended approach to ERCP for acute recurrent pancreatitis
  Final diagnosis in recurrent acute pancreatitis after extensive investigation
   Our experience
   Occult neoplasms
   Endoscopic treatment and results
Outstanding issues and future trends
Chronic pancreatitis
Treatments for chronic pancreatitis
  Medical therapy
  Surgical therapy
  Endoscopic treatment for chronic pancreatitis
   Safety issues
   Indications for endoscopic treatment
   Results of endoscopic treatment
Pancreatic ductal strictures
  Pancreatic stent placement techniques
  Efficacy of pancreatic duct stenting
   Cremer and colleagues
   Ponchon and colleagues
   Smits and colleagues
   Ashby and Lo
   Hereditary and early onset pancreatitis
   Predicting the outcome
  Duration of stenting
  Does response to stenting predict the outcome of surgery?
  Long-term follow-up
  Complications associated with pancreatic stents
   Stent-induced duct changes
   Brief mini-stents
Pancreatic ductal stones
  Causes of pancreatic ductal stones
  Stones cause obstruction
  Endoscopic techniques for stone extraction
   Pancreatic sphincterotomy
   Biliary sphincterotomy also?
   Pancreas divisum
   Stone removal
   Results of endoscopic treatment for stones
   Sherman and colleagues
   Smits and colleagues
   Cremer and colleagues
   Summary results
   Endoscopic therapy with ESWL
   Sauerbruch and colleagues
   The Brussels group
   Kozarek and colleagues
   Farbacher and colleagues
   Intraductal lithotripsy
   Medical treatment for stones
   Overall results for stone treatment
Pancreatic pseudocysts
  Endoscopic treatment for pseudocysts
Biliary obstruction in chronic pancreatitis
  Standard biliary stents
   Deviere and colleagues
   The Amsterdam group
   Barthet and colleagues
  Metal stents for biliary obstruction?
  Biodegradable stents
  Stenting for biliary strictures and chronic pancreatitis: conclusion
Sphincter of Oddi dysfunction in chronic pancreatitis
  Pathogenesis of SOD in chronic pancreatitis
  Frequency of SOD in chronic pancreatitis
  Surgical sphincter ablation
  Endoscopic pancreatic sphincterotomy
Pancreas divisum
  Pancreas divisum: a cause of pancreatitis?
  Minor papilla ablation
Outstanding issues and future trends
Toxic and metabolic complications
Pancreatic fluid collections
Pseudocysts and abscesses
Pancreatic necrosis
  Organizing necrosis
Miscellaneous complications
  Pancreatic fistulas
  Ductal disruption
  Vascular complications
   Venous thrombosis
Arterial complications
Outstanding issues and future trends
Patient preparation
  Sedation for ERCP in children
  Antibiotic prophylaxis
  Other medication
  Biliary indications
  Pancreatic indications
Success rates for ERCP in children
Biliary findings (Fig. 3)
  Biliary atresia vs. neonatal hepatitis
   ERCP findings
  Miscellaneous genetic cholestatic diseases
  Bile plug syndrome
  Choledochal cyst
   Pathogenesis of choledochal cyst
   Classification of anomalous ductal union
   Classification of choledochal cysts
   Type I
   Type II
   Type III
   Type IV
   Type V
   Treatment of choledochal cysts
   Fusiform choledochal dilatation and carcinoma
  Primary sclerosing cholangitis
  Parasitic infestation
   ERCP for stones
  Biliary strictures and leaks
   Primary stricture
   Malignant strictures
   Liver transplantation
   Bile leaks
Pancreatic findings (Fig. 17)
  Recurrent pancreatitis
   Choledochal cyst and anomalous pancreatico-biliary union
   Pancreas divisum
   Prevalence of pancreas divisum
   Significance of pancreas divisum
   ERCP diagnosis of pancreas divisum
   Treatment of pancreas divisum
   Other pancreatic congenital anomalies
   Duodenal duplication cyst
   Sphincter of Oddi dysfunction
   Pancreatic trauma
   Acquired immunodeficiency syndrome
  Chronic pancreatitis
   Endoscopic treatment of chronic pancreatitis in children
  Pancreatic pseudocysts
Outstanding issues and future trends
The risks of ERCP
  Risks for endoscopists and staff
  Technical failure
   Degree of difficulty scale for ERCP procedures (Fig. 1)
   Level 1
   Level 2
   Level 3
   Defining intent
   Risk consequences of technical failure
  Clinical failure
Unplanned adverse clinical events—complications
  When does an event become a complication?
   Complication definition
   Severity criteria
  Types of adverse clinical events
  Timing of events and attribution
  A dataset for unplanned events
Overall complication rates
  Accuracy of data collection
  Changes in complications over time
  Complication rates at MUSC
General risk issues
  Operator-related issues
  Patient-related issues; clinical status, indications, and comorbidities
   Illness and associated conditions
   Anatomical factors
   Complication-specific risk factors
  Procedure performed
   Diagnostic or therapeutic?
   Biliary sphincterotomy
   Pancreatic sphincterotomy
   Precut sphincterotomy
   Repeat sphincterotomy
   Balloon sphincter dilation
   Endoscopic papillectomy
   Pseudocyst drainage
Reducing the risks of ERCP: general issues
  The contract with the patient; informed consent
   Educational materials
  Care after ERCP
   Early refeeding?
Pancreatitis after ERCP
  Incidence of pancreatitis after ERCP
  Risk factors for pancreatitis
   Patient factors increasing the risk [114,115,122,123]
   Procedure factors increasing the risk
   Pancreatic manipulation
   Sphincter manometry
   Biliary sphincter dilation
   Biliary stenting
   Pancreatic stenting
   Combining patient- and procedure-related factors
  Prevention of pancreatitis after ERCP
   Avoiding ERCP, especially in high-risk patients
   Mechanical factors
   Contrast agents
   Pharmacological prophylaxis
   Pancreatic stenting to prevent pancreatitis
   Feeding and monitoring
  Post-ERCP pancreatitis, recognition, and management
  Post-ERCP pancreatitis, conclusion
  Duct and tumor 'penetrations'
  Sphincterotomy-related perforation
   Risk factors for sphincterotomy perforation
   Recognition of sphincterotomy perforation
   Reducing risks of sphincterotomy perforation
   Management of sphincterotomy perforation
  Perforation remote from the papilla
   Recognition and management of endoscopic perforation
  Stent migration perforation
Infection after ERCP
  Nosocomial infection
  Pancreatic sepsis
  Prophylactic antibiotics
  Delayed infection
Bleeding after ERCP
  Definition of bleeding, and incidence
  Risk factors for bleeding, and avoidance
  Management of sphincterotomy bleeding
   Delayed bleeding
Complications of stents
  Blockage of (plastic) biliary stents
  Stent migration
  Duct damage due to stents
Basket impaction
Cardiopulmonary complications and sedation issues
Rare complications
Deaths after ERCP
Late complications
  Diagnostic error
  Late infection
  Late effects of sphincterotomy
  Sphincterotomy with the gallbladder in place
  Pancreatic sphincterotomy
Managing adverse events
  Prompt recognition and action
  Professionalism and communication
Learning from lawsuits
  Financial concerns
  Standard of care practice
   The procedure
   Postprocedure care
Outstanding issues and future trends

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