Percutaneous management of cholangiocarcinoma

Key points

In general, the higher the cholangiocarcinoma (type 3 and type 4) and the more multifocal the disease/obstruction, the more likely the patient is to require percutaneous therapy/drainage rather than endoscopic drainage.
The two chief indications for preoperative biliary drainage are (1) the presence of preoperative cholangitis and (2) estimated FLR <30%. The goal of percutaneous biliary drainage is hepatic reserve optimization by improving coagulopathy and resolving any hepatorenal syndrome, thereby improving surgical outcome.
The disadvantages of performing drainage prior to resection include introduction of polymicrobial organisms to the biliary tree.
Ultimately, the possible advantages of covered stents should also be weighed against their increased expense, especially in light of the fact that many patients will not outlive a bare metal stent. This may explain why recent randomized trials (bare stents vs. covered stents) have not shown a clear and significant patency advantage of covered stents when compared to bare stents.
A randomized trial of photodynamic therapy versus conventional biliary drainage demonstrated a survival benefit so significant (98 vs. 493 days, P < 0.0001) that the trial was terminated early.
Transarterial catheter therapy (whether chemoembolization or radioembolization) have shown promising initial results in the management of cholangiocarcinoma.
Percutaneous tumor ablation is feasible, with good results; however, its role in the overall management of cholangiocarcinoma is yet to be determined.

Introduction

Cholangiocarcinoma is the second most common primary liver malignancy, after hepatocellular carcinoma, and its incidence appears to be increasing. Approximately 2000 cases are reported annually in the United States. Nearly two thirds of cases occur in patients aged 50–70, with a male predominance. The presenting symptoms of cholangiocarcinoma include jaundice, weight loss, pruritis, pain, and liver failure. Because symptoms typically occur late in the disease, staging at diagnosis tends to be advanced and prognosis for the disease is poor overall, with certain subgroups having extremely poor survival. Overall, patients with biliary duct malignancies have a reported median survival of 3–10 months. It should also be noted that gallbladder carcinoma, central intrahepatic metastasis, and metastatic lymphadenopathy may also result in malignant biliary obstruction, which may present similar to cholangiocarcinoma. Although this chapter attempts to primarily reflect the scientific literature on cholangiocarcinoma, some of the principles will also apply to these other etiologies of biliary obstruction. Moreover, on review of the literature, all etiologies of malignant biliary obstruction are commonly amalgamated and, as a result, it is difficult to ascertain outcomes that are specific to cholangiocarcinoma.

The current chapter focuses on the percutaneous biliary drainage and management of cholangiocarcinoma. Cholangiocarcinomas are a heterogenous group of tumors in terms of their size, location, symptoms, and survival ( Table 11-1 ). The complexity of this multifaceted subject, with its numerous variables, is compounded by the fact that varying techniques and methods are often amalgamated from an outcomes standpoint ( Table 11-1 ). This goes as far as amalgamating the outcomes of endoscopic and percutaneous management together, and thus in many studies it is commonly difficult to ascertain specific outcomes of percutaneous management overall, let alone evaluate outcomes that are specific to particular percutaneous techniques/stent. In this chapter, we will first discuss biliary drainage for cholangiocarcinoma in terms of its indications, technique, and method of drainage (endoscopic vs. percutaneous). We will also discuss the various types and configurations of biliary catheters and stents available, and the rationale for their use. In addition, the impact of the obstructing lesion (distal vs. hilar, right vs. left) on the treatment approach will be discussed ( Table 11-1 ). The preliminary results of covered versus bare stents will also be discussed along with locoregional transluminal therapies.

TABLE 11-1

Complexity and Variability in Evaluating Cholangiocarcinoma From the Literature

Variables in Describing and Managing Cholangiocarcinoma
Indications	Preoperative vs. palliative management
Location of Cholangiocarcinoma	Hilar vs. distal cholangiocarcinoma ( Figure 11-1 )
Modality of management	Endoscopic vs. percutaneous management
Laterality of approach	Right-sided vs. left-sided PTC and percutaneous biliary drainage
Degree of drainage	Unilobar vs. bilobar hepatic biliary drainage
Endoprosthesis (stents)	Plastic vs. metallic endoprosthesis (stents)
	Covered metallic vs. bare metallic stents
	Y-configured vs. T-configured metallic stents

Management overview

Cholangiocarcinomas are a heterogenous group of tumors in terms of their size, location, symptoms, and survival. Figure 11-1 demonstrates the terminology of cholangiocarcinoma based on location. Management needs to be individually tailored for each patient. In terms of location, multiple classification schemes exist. Cholangiocarcinoma may be described as proximal/distal or, using the Bismuth-Corlette classification system as types 1, 2, 3a, 3b and 4 according to their intrahepatic/hilar/extrahepatic distribution ( Figure 11-2 ). Type 1 lesions generally have the best prognosis, while type 4 lesions have the poorest prognosis.

Figure 11-1, Terminology associated with the location of cholangiocarcinoma. Hilar cholangiocarcinoma (Klatskin tumor) is further classified according to the Bismuth-Colette classification (see Figure 11-2 ).

Figure 11-2, Bismuth classification. Bismuth-Corlette Type I: Tumor is in the common hepatic duct and does not involve the confluence of the right and left main biliary ducts. Bismuth-Corlette Type II: Tumor is at the confluence of the right and left main biliary ducts. Bismuth-Corlette Type III: Tumor is at the confluence of the right and left main biliary ducts and extends to one of the second-order confluences: either right or left. Bismuth-Corlette Type IV (not drawn): Tumor is at the confluence of the right and left main biliary ducts and extends to both of the second-order confluences: right and left.

Overall, patients with biliary duct malignancies have a reported median survival of 3–10 months, particularly when the presenting symptoms are associated with biliary obstruction, which is usually the case. Medical therapy is very limited for cholangiocarcinoma and no standard chemotherapy regimen exists, because of minimal survival benefit. Radiation therapy is controversial because of limited efficacy and increased risk of complications (cholangitis, gastroduodenitis, and increased hospitalization). Decompressive surgery is the traditional treatment for obstructing cholangiocarcinoma. The majority of surgeries are performed for palliation, with less than 30% of patients with cholangiocarcinoma having a chance for a curative resection. Moreover, many patients at the time of presentation are not surgical candidates, with up to 70%–80% of patients being nonsurgical candidates. As a result, most nonsurgical patients are managed by minimally invasive means (endoscopic or percutaneous biliary drainage). These minimally invasive approaches are now considered standard of care for many patients along with systemic or new loco-regional therapies.

Endoscopic versus percutaneous biliary drainage

Studies have shown that the method of biliary drainage has no impact on survival. However, endoscopic retrograde cholangiopancreatography (ERCP)–guided internal biliary drainage is often the preferred method of drainage and is generally thought to be less invasive than percutaneous drainage, because it does not require creation of an invasive transhepatic/transcapsular (Glisson capsule) tract. As a result, ERCP is the most definitely preferred procedure in patients with severe coagulopathy or ascites. However, there are several scenarios in which endoscopic drainage may fail or may not be feasible. In terms of disease location, ERCP generally can adequately drain the liver when a distal lesion is present, but may be more problematic in hilar lesions or in cases with multiple strictures. In general, the higher the cholangiocarcinoma (type 3 and type 4) and the more multifocal the disease/obstruction, the more likely the patient is to require percutaneous therapy/drainage rather than endoscopic drainage.

Additionally, previous upper gastrointestinal tract surgery (Bilroth II or gastric bypass, to name two) may make endoscopic stent placement difficult or impossible. In these cases, percutaneous drainage may succeed where endoscopic drainage has failed. In cases of proximal lesions or in patients with multiple strictures (numerous intrahepatic isolated biliary segments), percutaneous drainage may be superior because it can specifically target the area of abnormality or biliary tract dilation. However, it is important to note that cholangiocarcinomas with more advanced Bismuth class (corresponding to more diffuse involvement) tend to have fewer dilated intrahepatic ducts on imaging studies and that hilar cholangiocarcinoma accounts for 40%–60% of all cholangiocarcinomas.

Percutanous transhepatic management

Patients undergoing percutaneous transhepatic cholangiography (PTC) for purely diagnostic purposes is largely a thing of the past and the vast majority of patients are now diagnosed on the basis of noninvasive imaging such as magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or ultrasonography prior to any minimally invasive procedure (ERCP or PTC) (please see Preprocedural Imaging section). Percutaneous transhepatic management can be classified into (1) PTC and percutaneous transhepatic biliary drainage, (2) internalization of drainage by stent placement, and (3) new loco-regional therapies such as brachytherapy and photodynamic therapy.

Initial PTC and percutaneous drainage

Preoperative versus palliative biliary drainage

Percutaneous biliary drainage is typically indicated in one of two broad-based scenarios, preoperative (for surgical candidates) or palliative (in patients who will not have surgery). Surgery for cholangiocarcinoma can be performed with either the goal of a curative resection or for palliative decompression. In either of these scenarios, preoperative drainage can be entertained. Complete surgical resection, often necessitating major hepatic resection, remains the only possibility for cure in patients with cholangiocarcinoma. The role of orthotopic liver transplantation in this population is not well defined at present. As many as 90% of patients with cholangiocarcinoma are not candidates for curative resection. For patients who are not surgical candidates or who do not elect to undergo surgery, percutaneous biliary drainage may be performed as a palliative measure.

Currently, performing the drainage procedure prior to surgery is controversial and has been debated for years. As a result, practice varies between institutions. Many Asian centers have advocated preoperative drainage routinely, while Western centers have tended to be more conservative. The advantages of preoperative drainage include resolution of any preexisting cholangitis and optimization of the hepatic reserve. ^, The goal of hepatic reserve optimization is to improve coagulopathy and to resolve any hepatorenal syndrome, thereby improving the patient’s surgical outcome. The disadvantages of performing drainage prior to resection include introduction of polymicrobial organisms to the biliary tree. ^, Another potential disadvantage is increased morbidity both from the drainage procedure itself and from the associated increase in hospital stay. Moreover, a percutaneous biliary drainage catheter may hinder the ability to assess the full extent of the tumor both on preoperative imaging and intraoperatively.

In terms of hepatic reserve, the concept of future liver remnant (FLR) is important to understand. Future liver remnant, as the name implies, is defined as the difference between the total liver volume and the volume of resected liver. The FLR cannot be truly known until after the surgery; however, it can be accurately predicted preoperatively on CT or magnetic resonance imaging (MRI) using volumetric analysis. ^, If the FLR is expected to be less than 30%, patients tend to have worse surgical outcomes. Therefore, optimization of the hepatic reserve becomes more important in this group as it will improve the liver’s capacity for postoperative hypertrophy. ^, Two studies demonstrated that without percutaneous biliary drainage, postoperative hepatic dysfunction with an FLR less than 30% and greater than 30% was 24% vs. 0%, respectively. Similarly, the postoperative death with an FLR less than 30% and greater than 30% was 19% versus 5%, respectively. ^,

Therefore, the two chief indications for preoperative biliary drainage are (1) the presence of preoperative cholangitis and (2) estimated FLR <30%. These indications apply to both curative and palliative resections. These indications should be weighed against the significant risk of introducing polymicrobial infection from the procedure. Incidence of cholangitis following percutaneous drainage is reported at 20%–60%. Review of five Level 1 clinical trials demonstrates that 65% of patients who received preoperative drainage had biliary aspirates positive for polymicrobial organisms compared to 8% of patients who did not receive preoperative drainage. ^, In terms of preoperative management, it is important to obtain high-quality abdominal imaging prior to drainage in order to avoid the catheter compromising the preoperative imaging.

Indications

Patients undergoing PTC for purely diagnostic purposes is largely a thing of the past. Drainage for simply the relief of asymptomatic obstruction or visualization of dilated/obstructed biliary radicals is not an indication for PTC and subsequent percutaneous biliary drainage. ^, The clinical indications for PTC and subsequent biliary drainage is pruritis (particularly refractory to medical therapy), cholangitis, biliary sepsis, and hyperbilirubinemia in patients who will undergo systemic chemotherapy with agents that require hepatic metabolism and/or biliary excretion. ^, In a study by Robson and coworkers, the proportions of patients with the primary indication of pain/pruritis, jaundice precluding chemotherapy, and cholangitis were 18%, 53%, and 10%, respectively. These chemotherapeutic agents include 5-flourouracil (5-FU), irinotecan, and gemcitabine. The degree of reduction in serum bilirubin is the chief indicator of successful drainage. The target total bilirubin after percutaneous drainage for the administration of chemotherapeutic regimens is usually less than 2 mg/dL. ^,

Preprocedural workup and clinical evaluation

Preprocedure workup should include a detailed history (assessing indications and contraindications), physical examination, laboratory data, and noninvasive imaging. Because of the risk of bleeding from the procedure, coagulation parameters and platelets should be optimized. There are no set coagulation parameters; however, an international normalized ratio (INR) of less than 1.5 and a platelet count greater than 50,000–75,000/mm are common thresholds. The presence of preprocedure cholangitis should be carefully assessed for, as percutaneous drainage may worsen/disseminate any underlying infection. Prophylactic antibiotics are recommended. Common prophylactic antibiotics used include intravenous piperacillin and tazobactam combination or intravenous ceftriaxone. Preprocedural sedation and/or anesthesia evaluation is also performed, as PTC with subsequent drainage can be performed under moderate sedation, deep sedation, or general anesthesia.

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