Chapter Outline
Percutaneous Gallbladder Aspiration
Percutaneous Transhepatic Cholangiography and Drainage
Primary Sclerosing Cholangitis
Interventional radiology continues to play a key role in the management of patients with gallbladder and biliary tract disease. Advances in techniques and technologies have improved patient care with the availability of minimally invasive procedures that include percutaneous drainage, biopsy, and stone removal. Diagnostic procedures include percutaneous transhepatic cholangiography and intraluminal biopsy. Therapeutic procedures include percutaneous drainage-decompression of the biliary tree or gallbladder, dilation of a bile duct stenosis or surgical anastomosis, placement of endobiliary plastic or metallic stents, removal of gallstones, and, finally, percutaneous intraluminal treatment of biliary tumors. This chapter reviews the indications, techniques, outcomes, and recent advances of these interventional procedures in a multidisciplinary setting.
Preprocedural Management
The interventionalist should be familiar with the patient’s history, notably previous interventions including surgery. A recent physical examination is useful in evaluating the patient’s general condition and is necessary if moderate conscious sedation is being used, in which case the patient should be fasting for at least 6 hours. Review of previous imaging is also helpful for clarification of anatomy and prior procedures.
The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles that generally should assist in producing high-quality medical care. The membership of the Society of Interventional Radiology Standards of Practice Committee represents experts in a broad spectrum of interventional procedures from both the private and academic sectors of medicine, and as such they represent a valid expertise on preprocedural coagulation status and antibiotic prophylaxis.
A platelet count of 50,000/µL or lower requires a platelet infusion at the time of the interventional procedure. We generally prefer a prothrombin time of 18 seconds or less and will recommend administration of vitamin K and fresh frozen plasma in the nonacute and acute settings, respectively, to achieve this. Cessation of warfarin and clopidogrel is recommended for 4 to 5 days before the procedure. Unfractionated heparin should be stopped at least 4 hours and low-molecular-weight heparin should be stopped at least 12 hours in advance of the procedure.
Although the risk is low in nonobstructed ductal systems, infection is a significant contributor to morbidity and mortality, particularly in elderly or immunocompromised patients with gallbladder and hepatobiliary disease. We recommend prophylactic intravenous antibiotics in all patients undergoing procedures with few exceptions. Our preferred antibiotics are 1 g of ceftriaxone and 1.5 to 3 g of ampicillin/sulbactam. The hospital pharmacy and the infectious disease service are useful resources for appropriate antibiotic use.
Preprocedural verification and skin marking should be standard as part of the Universal Protocol. The Universal Protocol was created to address the continuing occurrence of wrong site, wrong procedure, and wrong person surgery in Joint Commission–accredited organizations. The three principal components of the Universal Protocol include a preprocedure verification, site marking as previously mentioned, and a time-out. A time-out for patient safety is called immediately before the procedure, which includes identifying the patient by name and the type and site of procedure to be done.
Percutaneous Cholecystostomy
Acute cholecystitis is the most common cause of acute right upper quadrant pain and occurs in approximately one third of patients with gallstones. In most cases, the condition is due to calculous obstruction of the gallbladder neck or cystic duct, leading to increased intraluminal pressure and distention of the gallbladder.
Although early laparoscopic cholecystectomy is typically the preferred and definitive treatment for acute cholecystitis, the morbidity and mortality increase with the patient’s age and complexity, and percutaneous cholecystostomy (PC) has been used as a temporizing and sometimes definitive therapy in high-risk patients. This is a minimally invasive method of percutaneous placement of a drainage catheter in the gallbladder lumen under ultrasound and fluoroscopic guidance. A positive clinical response, which varies between 56% and 100%, is considered when there is a decrease in white blood cell count, defervescence, and decrease in the need for vasopressors. The risks of PC (bleeding, infection, and visceral perforation) are low. Mortality is associated mainly with the underlying medical conditions. PC can be followed by elective cholecystectomy at a later stage if the patient’s condition permits or by expectant or conservative management in those with acalculous cholecystitis.
The earliest reports describing PC for the treatment of acute cholecystitis date back some 30 years. Since then, multiple relatively small and predominantly single-institution series have been published, collectively supporting a role for imaging-guided percutaneous gallbladder decompression in high-risk patients.
In a review of Medicare data between 1994 and 2009, annual PC procedures increased by 567% (from 1085 to 7239). During the same period, laparoscopic cholecystectomy procedures increased by 3% (from 203,836 to 209,650), and open procedures declined by 73%. Clinical acceptance of PC and the availability and expertise of interventional radiologists have both contributed to an increased use of PC. Expanding the availability of PC may have acted as a “convenience factor” as well, lowering thresholds for use over time and thus contributing to PC’s growth. Some growth is also attributable to an aging population with an increasing number of comorbidities.
Traditionally, it was believed that whereas percutaneous drainage represented a valuable intervention, secondary cholecystectomy was mandatory in cases of acute calculous cholecystitis. However, considering limited survival and a low recurrence rate of cholecystitis in elderly high-risk patients with acute cholecystitis, PC is increasingly being accepted as a definitive treatment, and cholecystectomy may not be necessary after resolution of the acute symptoms with gallbladder drain exchanges every 6 to 8 weeks.
Without evidence from randomized controlled trials comparing PC with surgery in such populations, however, the optimal role and timing of PC remain unclear. Historically, PC has been used in higher risk, often elderly and critically ill patients. As a result, studies comparing the percutaneous technique with cholecystectomy have shared a retrospective study design and selection bias as they have not evaluated comparable groups. Abi-Haidar and colleagues described a 10-year cohort of patients who underwent both techniques. As in other studies, the PC patients were older, had higher American Society of Anesthesiologists classification, and had more comorbidities. Not surprisingly, they experienced more readmissions and complications and had a longer hospital stay. The Cochrane Database Review Group compared two randomized prospective studies, PC followed by early laparoscopic cholecystectomy versus delayed laparoscopic cholecystectomy (70 patients) and PC versus conservative treatment (86 patients), and concluded that the studies had high risk of bias. There was no significant difference in overall morbidity between the two intervention groups. On the basis of available evidence from these randomized clinical trials, the Cochrane Review Group was unable to determine the role of PC in the clinical management of high-risk surgical patients with acute cholecystitis and expressed a need for adequately powered randomized clinical trials of low risk of bias.
Two patient populations deserve consideration for this procedure: those with critical illness and those with a high likelihood of conversion from a laparoscopic to an open procedure. In the case of critical illness, particularly patients who develop acute cholecystitis during an intensive care unit stay, PC has a continued role in light of evidence that emergency cholecystectomy in the critically ill is associated with higher mortality rates than cholecystectomy.
An international consensus panel of hepatobiliary surgeons defined the diagnostic criteria and severity assessment of acute cholecystitis as part of the Tokyo Guidelines (TG07) in January 2007. In the TG07, PC should be used in patients with grade II (moderate) cholecystitis only when they do not respond to conservative treatment and for patients with grade III (severe) disease. For patients with severe (grade III) disease, gallbladder drainage is recommended, followed by intensive care.
The updated Tokyo Guidelines 2013 (TG13) describe the surgical treatment for acute cholecystitis according to the grade of severity, the timing, and the procedure used for cholecystitis in a question-and-answer format using the evidence concerning surgical management of acute cholecystitis. Consequently, it was agreed that cholecystectomy is preferable early after admission. However, literature concerning the surgical treatment according to the grade of severity could not be quoted because there have been no publications on this topic, but the consensus was to perform percutaneous drainage when conservative treatment is failing. One prospective study showed that predictors for failure of conservative treatment are age older than 70 years, diabetes, tachycardia, and distended gallbladder at admission. Likewise, white blood cell count (>15,000 cells/mL), elevated temperature, and age older than 70 years were found to be predictors for the failure of conservative treatment at 24- and 48-hour follow-up.
The CHOCOLATE trial is a current randomized controlled, parallel-group, superiority multicenter trial in The Netherlands in which high-risk patients with acute calculous cholecystitis will be randomized to laparoscopic cholecystectomy or PC.
Technique
Work-up includes review of the patient’s clinical status and imaging. The authors use a combination of ultrasound and fluoroscopic guidance to place a locking pigtail catheter in the gallbladder by a modified Seldinger technique. Liberal use of subcutaneous lidocaine is recommended in addition to conscious sedation with intravenous midazolam and fentanyl. Typically, an 18-gauge needle is advanced percutaneously into the gallbladder, after which the track is dilated over a short Amplatz stiff guidewire (Cook Medical, Bloomington, IN) with 6F and 8F dilators, followed by placement of an 8F locking pigtail that is connected to gravity drainage ( Fig. 78-1 ). Speed is of the essence during the procedure as bile leakage during dilator exchange and catheter placement may be very painful. Technique modifications include use of a transhepatic instead of a transperitoneal route because of a higher risk of complications due to drain dislocation and also the use of a single-stick or trocar method to access the gallbladder instead of the Seldinger technique. Intuitively, the trocar or single-stick technique should be less painful and is preferred by some to the Seldinger technique for catheter placement. However, we think that the trocar technique may be more difficult in patients whose gallbladders are small or thick walled.
We rarely inject more than a few milliliters of contrast material to confirm the location of the tube to avoid bacteremia. A tube check is better done within 5 to 7 days to evaluate for cystic and common duct patency, followed by capping of the tube to promote internal drainage.
Percutaneous Gallbladder Aspiration
Ultrasound-guided aspiration of gallbladder contents offers a less invasive and sometimes just as effective an alternative to percutaneous gallbladder drainage for acute cholecystitis. The procedure can be performed at the bedside under ultrasound guidance with either a 21- or 18-gauge needle and has two main advantages over PC. First, the quoted complication rate is lower because aspiration involves fewer steps than drainage and the needle is narrower than any drainage catheter placed. Second, the patient’s comfort and convenience are better with aspiration as the presence of a drainage catheter and bag may be cumbersome. In certain situations, however, PC is preferable to gallbladder aspiration. Aspiration may not be technically feasible in patients with viscous bile. Also, because it does not provide continuous drainage, gallbladder aspiration is inappropriate in patients in whom the indication for gallbladder drainage is to provide relief from a distal biliary obstruction.
In a meta-analysis of 11 studies comparing aspiration with PC, the clinical response to PC was slightly better compared with aspiration. However, the complication rate of PC was also higher than that of aspiration, with 4 of the 11 studies in this review having a complication rate in the range of 10% to 23%, which is well above the threshold set by the Society of Interventional Radiology Standards Committee.
In one of these comparative studies, the authors recommended that aspiration should be the procedure of choice in high-risk patients, reserving PC as a salvage procedure if aspiration is technically or clinically unsuccessful. Interestingly, almost one quarter of patients in this study did not show a clinical response within 72 hours of gallbladder aspiration and had a salvage PC. Using this approach of gallbladder aspiration with salvage PC, the authors avoided PC in 77% of patients while obtaining the overall positive clinical response rate close to that of PC.
Acalculous Cholecystitis
Acute cholecystitis can develop without gallstones in critically ill or injured patients. However, the development of acute acalculous cholecystitis is not limited to surgical or injured patients or even to the intensive care unit. Diabetes, malignant disease, abdominal vasculitis, congestive heart failure, cholesterol embolization, and shock or cardiac arrest have been associated with acute acalculous cholecystitis. Children may also be affected, especially after a viral illness. The pathogenesis of acalculous cholecystitis is thought to include ischemia and reperfusion injury, but opioids, positive pressure ventilation, and total parenteral nutrition have been implicated. The clinical presentation is nonspecific, and significant delays in diagnosis result in a high incidence of gangrene, perforation, abscess, and death. To improve outcome, a high index of suspicion with early imaging, often using multiple studies, is necessary. Ultrasound of the gallbladder is the most accurate diagnostic modality in the critically ill patient, with gallbladder wall thickness of 3.5 mm or greater and pericholecystic fluid being the two most reliable findings.
Boland and associates recommend prophylactic PC for all intensive care unit patients with abdominal sepsis who are not improving and for whom no other etiology can be found. In their series, almost 60% of these patients improved without further treatment. In the rest, the gallbladder was excluded as the source of sepsis, redirecting the search elsewhere.
Interval cholecystectomy is usually not indicated after acalculous cholecystitis in survivors. If the absence of gallstones is confirmed and the precipitating disorder has been controlled, the cholecystostomy tube can be removed once a track has formed after the patient has recovered.
Percutaneous Transhepatic Cholangiography and Drainage
Percutaneous transhepatic cholangiography (PTC) is used to visualize the intrahepatic and extrahepatic ductal system, most commonly to identify the nature and location of biliary obstruction due to stones, tumor, or benign stricture and less commonly to detect a bile leak ( Fig. 78-2 ). If either obstruction or leak is diagnosed, percutaneous biliary drainage, with or without adjunctive stenting, is usually attempted at the same time. Although magnetic resonance cholangiopancreatography (MRCP) also visualizes the ductal system, the combination of PTC and drainage (PTCD) allows a one-step diagnosis and treatment procedure. The majority of patients requiring drainage have malignant disease and eventually have a metallic stent placed. Percutaneous transhepatic access is also useful for balloon dilation of strictures and biopsy.
Technique
For a right-sided fluoroscopic approach, an intercostal point in the midaxillary line is marked in the mid liver with attention paid to the locations of the pleura and colon. The patient should have received antibiotics and conscious sedation. After liberal injection of local anesthetic subcutaneously and down to the hepatic capsule, a 15-cm 22-gauge needle is advanced into the liver in a slightly cephalad direction. The needle obturator is removed and the needle is gradually withdrawn while contrast material is injected gently. Opacification of a bile duct is characterized by an accumulation of contrast material, which persists, unlike vascular opacification, which is transient. Another confirmatory feature is that contrast material in the biliary system drains toward the hilum, in contrast to hepatic arterial or portal venous flow, which is away from the hilum. However, if the biliary tract is occluded, flow of contrast material within it may be very slow. Nondilated ducts are more difficult to access. Next, having confirmed that the opacified bile duct has been accessed peripherally, one should advance a 0.018-inch guidewire into the ductal system as far as the obstruction under fluoroscopic guidance. The authors prefer to use a Neff set (Cook), which is a tapered triaxial access system. Once the Neff dilator is in the duct, its inner two components can be removed, and a 5F Kumpe catheter (Cook) and guidewire can be used to traverse the duct obstruction and to access the duodenum. Once the catheter is in the duodenum, the guidewire can be changed for a stiffer version over which an 8F or 10F internal/external biliary drainage catheter is advanced and the pigtail loop formed in the duodenum. This drainage catheter has multiple side holes allowing drainage above and below the biliary tract obstruction. If traversal of the biliary obstruction is not possible initially, placement of a pigtail drain above the obstruction allows external decompression, and traversal of the obstruction is reattempted after several days.
A left-sided PTC is usually under ultrasound guidance with a subcostal approach to access a segment II or III duct. Once the intraductal needle tip location is confirmed on ultrasound, contrast material is injected, outlining the duct. Again, placement of an internal/external or external biliary drainage catheter is as previously described.
Complications
Important complications include bleeding, infection, and visceral perforation. Significant bleeding, which occurs in 2% to 3%, may be classified on the basis of its source: perihepatic bleed sites (hemothorax, hemoperitoneum, subcapsular hepatic hematoma); gastrointestinal bleeding (hemobilia or melena); and bleeding from the percutaneous biliary drain itself, which is the most common clinical presentation. Methods to evaluate and to treat this complication include tractography, angiography, track embolization, arterial embolization, and track site changes. Bleeding is more common when the ductal system is accessed centrally than peripherally. Left-sided PTCD is associated with a higher bleeding complication rate than a right-sided approach, presumably because of the greater proximity to larger vessels.
Significant pain can occur after removal of transhepatic catheters from biliary access tracks, after percutaneous biliary drainage or stenting. The track may be embolized to prevent bile leak and bleeding, reducing the patient’s pain.
Biliary Strictures
Malignant Stricture
Bile duct obstruction is commonly caused by pancreaticobiliary malignant neoplasms including gallbladder cancer, cholangiocarcinoma, and pancreatic neoplasms that are frequently unresectable at the time of diagnosis. Inoperable malignant bile duct obstruction can be palliated with surgical bypass, placement of percutaneous biliary drainage catheters, and endoscopic or percutaneous biliary stenting. Indications for biliary drainage/stenting include pruritus, cholangitis, and lowering of bilirubin concentration (<2 mg/dL) before chemotherapy.
Percutaneous biliary drainage is achieved by placement of an internal/external or external plastic pigtail drain after PTC as outlined before. In a review of patients with malignant biliary obstruction who had placement of internal/external biliary drains for lowering of bilirubin concentration, pericatheter leakage occurred in nearly one third of cases, requiring three visits per 100 catheter-days, or approximately one per month. Only 31% of patients attained a normal serum bilirubin level by 100 days, and median overall survival was 107 days. Careful patient selection is warranted before biliary drainage for this indication. Maximal biliary drainage, a preprocedure total serum bilirubin concentration of less than 9 mg/dL, and a lower international normalized ratio were factors associated with normalization of the serum bilirubin level in this cohort. In another study from the same institution, it was found that the patient’s “quality of life” did not improve after catheter drainage regardless of technical success. Whereas palliation of pruritus was probable, the procedure was less successful in lowering the serum bilirubin concentration to a level that permitted the administration of chemotherapy. The authors concluded that biliary drainage without a clear clinical indication was not supported.
Internalization of drainage may be achieved with either plastic or metal stents. Compared with plastic stents, metal stents are of larger diameter, have better long-term patency, and are more expensive. The use of metal stents is preferred for patients who are expected to survive for more than 6 months, whereas for patients who are likely to survive for less than 6 months, the use of plastic stents is appropriate. Obstruction in a metal stent may be caused by bile sludge, food debris, or tumor ingrowth. To overcome the last problem, covered metal stents were developed, and these stents are now used in patients with malignant distal biliary obstruction. However, despite their superiority over noncovered stents in terms of improved patency, the incidence of acute cholecystitis and stent migration is higher.
Traditionally, endoscopic stent placement was the preferred method to treat bile duct obstruction because it had higher success and lower complication rates and did not require an external drainage catheter. More recent studies reflect a reversal of this experience, with percutaneous stent placement being more successful and associated with fewer complications than endoscopic procedures, with the main procedural complication, cholangitis, occurring almost five times more commonly with endoscopically placed stents than with percutaneously placed ones. Percutaneous transcholecystic placement of metallic stents is a feasible and effective method to manage malignant obstruction at the lower level of the common bile duct when conventional biliary drainage through transhepatic or endoscopic access is technically difficult.
In primary stenting, the stent is placed at the same session as the initial biliary system access, and this has been found to be effective and safer than a staged procedure with secondary stenting. In a review of 61 patients stented transhepatically for malignant biliary duct obstruction, the rate of major complications was 23% in the primarily stented group and 54% in the secondarily stented group. Primary stenting is also more cost-effective because of a shorter hospital stay. Reduced morbidity and hospital stay with this technique has been corroborated by other investigators.
A reasonable approach to draining patients with bilobar biliary obstruction may be to insert only a single metallic stent into a liver lobe that constitutes 70% or more of the liver volume, is less involved by tumor than the other lobe, and is supplied by a patent lobar portal vein branch. Patients with liver lobes of similar size and patent lobar portal vein branches might benefit from bilobar drainage. Drainage of more than two biliary segments is best avoided, except in patients presenting with cholangitis, because of a higher complication rate. The main predictive factor for drainage effectiveness in patients with hilar tumors was a drained liver volume of more than 50%, especially in Bismuth III strictures, which may require bilateral stent placement. Draining an atrophic lobe (<30% of volume) is ineffective and increases the risk of cholangitis.
Benign Stricture
Percutaneous balloon dilation has become a safe and effective long-term alternative to endoscopic or surgical treatment for benign biliary strictures of various causes. According to the location of the involved duct, the strictures can be categorized as duct anastomotic, biliary-enteric anastomotic, and duct nonanastomotic. The anastomotic strictures represent localized narrowing caused by fibrosis, whereas the nonanastomotic strictures are likely to be associated with ductal ischemia from damage to the bile duct arteries from a variety of causes, including hepatic artery thrombosis. A stricture developing after biliary-enteric anastomosis after low division of the bile duct may be explained by damage to the bile duct artery. Recent experience suggests that anastomotic strictures are more amenable than nonanastomotic strictures to balloon dilation ( Fig. 78-3 ).
