Gastrointestinal Intervention 2018; 7(2): 67-73  https://doi.org/10.18528/gii180017
Preoperative biliary drainage for pancreatic cancer
Osman Ahmed, and Jeffrey H. Lee*
Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, Houston, TX, USA
*Department of Gastroenterology, Hepatology and Nutrition, University of Texas MD Anderson Cancer Center, 1840 Old Spanish Trail, Houston, TX 77054, USA. E-mail address:jefflee@mdanderson.org (J.H. Lee). ORCID: https://orcid.org/0000-0001-6740-3670
Received: May 2, 2018; Revised: July 16, 2018; Accepted: July 16, 2018; Published online: July 31, 2018.
© Society of Gastrointestinal Intervention. All rights reserved.

cc This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract

Pancreatic cancer is a leading cause of cancer-related morbidity and mortality, but any meaningful improvement in its prognosis remains elusive. The lack of early diagnostic methods means that many patients only present when symptoms develop, such as obstructive jaundice. Once a diagnosis of pancreatic cancer has been made in a patient with obstructive jaundice, then a decision should be made if the patient is a candidate for surgical resection. Patients who are candidates for surgical resection generally do not need preoperative biliary drainage, unless they present with cholangitis, or if they require neo-adjuvant chemotherapy. If preoperative biliary drainage is to be done, then patient factors and local expertise should guide appropriate interventions. The evidence for endoscopic retrograde cholangiopancreatography as a first-line therapy for biliary decompression is strong; However, the use of percutaneous transhepatic biliary drainage as well as endoscopic ultrasound-guided biliary drainage has generally not been found to be inferior. Finally, to ensure ongoing patency and minimize complications, an appropriate self-expanding metal stent should ideally be placed.

Keywords: Endoscopy, Obstruction, Pancreatic cancer, Ultrasound
Introduction

Cancers related to the pancreas are one of the most common malignancies with an estimated incidence of fifty-five thousand new cases annually. It is also the third-most common cause of cancer-related mortality in the United States with an estimated forty-thousand deaths in 2017, and a leading cause of cancer-related morbidity.1 Even more worrisome is that pancreatic cancer is expected to become the second leading cause of cancer-related mortality.2 Unfortunately, therapies related to pancreatic cancer have not improved as drastically as desired, with the 5-year survival rate still approaching less than ten percent.3,4 One of the main reasons for the high mortality rate is due to the lack of current modalities available to diagnose pancreatic cancer at an early stage. In fact, it is thought that less than 20% of pancreatic cancers are diagnosed at an early enough stage to be considered for surgery, which till today, remains the only curative therapy available.5 Similarly, only 10% of patients with pancreatic cancer are considered to have localized disease.1

One of the reasons for the lack of early recognition is the lack of success in identifying screening modalities that can be implemented. There has been a concerted and immense effort to determine evidence-based screening protocols, but with lacking results. Previous trials related to serum tumor markers (such as CA 19-9, etc.) have not been fruitful in demonstrating improved mortality.6 Similarly, targeting screening of high-risk individuals (known mutations, family history, associated medical conditions) have also similarly failed to demonstrate any benefit.7 Finally, although the current modalities that exist in terms of investigating suspicious lesions (endoscopic ultrasound [EUS], computed tomography [CT], magnetic resonance imaging [MRI]) are rapidly improving, they are still not ideal for average-risk screening.8 Unfortunately, the lack of screening and tools has led to the low rate of early diagnosis of tumors.

Another difficulty in the early diagnosis of pancreatic cancer is due to its insidious growth. Tumors generally reach a threshold size before they present with any symptoms, and unfortunately this results in presenting at an advanced stage. The symptoms for pancreatic cancer are, if present, abdominal pain, weight loss, asthenia, and/or anorexia, which do not generally lead to a concern about pancreatic cancer.9 Patients may present with initial features of diabetes mellitus due to the disruption of the pancreas’ endocrine function.10

The most common location for pancreatic ductal adenocarcinoma is the head, with roughly 70% of cases, followed by the body and tail. When tumor growth is the head of the pancreas, initial presentation is often with obstructive jaundice.11 Consequently, one of the most common complications related to pancreatic cancer is the development of biliary obstruction from compression of the bile duct by the mass in the head of the pancreas.11 Intuitively, obstructive jaundice is a common reason for recurrent presentations to hospital in patients with pancreatic cancer, and can sometimes be the initial finding leading to the diagnosis of pancreatic cancer. It is estimated that up to 77% of patients with a mass in the head of the pancreas turn out to have pancreatic cancer.12

There should be a few considerations that should occur in patients with obstructive jaundice with regards to pursuing biliary drainage (BD) preoperatively. Firstly, the decision on whether to pursue preoperative BD must be addressed in light of the mixed evidence on its utility, and secondly, if a decision is made to drain, which therapy should be performed must be individualized. In this review, we will examine the evidence for preoperative BD and the options available.

Preoperative Biliary Drainage

In the setting of resectable pancreatic cancer

The evidence of whether to pursue preoperative BD is controversial, with the risks balancing against the benefits of decompressing the biliary tree. The reasons to pursue aggressive decompression are multifold; it provides relief of jaundice, nausea, pruritus, loss of appetite, and helps avoid hepatotoxicity for the patient receiving neo-adjuvant chemotherapy. Although the benefits of achieving BD might seem straight-forward, they need to be balanced with the risks of the procedures involved. The seminal data to show the negative aspects of preoperative BD was a multicenter randomized controlled trial performed by van der Gaag et al13 in 2010. In the study, patients were randomized to either preoperative BD (generally through the use of endoscopic retrograde cholangiopancreatography [ERCP]) for 4 to 6 weeks followed by surgery, or early surgery within one week without BD. The primary outcome was any serious complication within the first 120 days. The results demonstrated that 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group developed serious complications. The main difference between the two groups was largely explained due to procedure-related complications in the group undergoing BD. Of note, mortality and length of hospital stay did not differ.13 However, this study has limitations, mainly high rates of initial ERCP failure (25%) and ERCP complications (46%), which stem from the study design of multicenter participation; many centers in the study performed only a small number of ERCPs annually.

Nonetheless, there have been two Cochrane reviews looking at the role preoperative BD in patients with obstructive jaundice. Although the first review in 2008 was non-committal due to poor evidence, a subsequent update in 2012 firmly demonstrated the risks of preoperative BD outweighed the benefits, especially if timely access to surgery was feasible.14,15 The second review used six trials involving 520 patients, and found that preoperative BD was associated with increased morbidity, but did not affect overall mortality. This review was limited due to the fact that four out of the six studies involved percutaneous transhepatic cholangiography (PTC) drainage, rather than the more conventional ERCP, as currently practiced. Two recent systematic reviews and meta-analysis have investigated the same issues, incorporating more modern studies and including contemporary methods of BD. Nevertheless, they each arrived to the same conclusions, showing that there was no difference in survival outcomes but that preoperative BD was associated with an increase in complications, including wound infections.16,17 Considering all evidence, we recommend no BD if the patient is undergoing surgery within 2 weeks, and BD if surgery will be delayed more than 2 weeks.

In the setting of neo-adjuvant therapy

While the role of neo-adjuvant chemoradiation in patients with resectable pancreatic cancer remains controversial, it is generally agreed that neo-adjuvant therapy is beneficial in borderline resectable pancreatic cancer. The cited benefits of neo-adjuvant therapy include down-staging disease, improving surgical resection outcomes by treating micro-metastatic disease, and potentially increasing the range of surgical candidates. It also identifies patients who have rapidly progressing disease that will likely not benefit from surgical therapy. Previous studies have identified the use of gemcitabine-based therapy (with or without cisplatin) as well as radiation as potential neo-adjuvant therapies to explore.18,19 Preoperative BD is prerequisite for neo-adjuvant chemotherapy. Elevated bilirubin, and ongoing obstruction are generally considered to be contra-indications to chemotherapy, due to the increase risk of chemo-related toxicity sepsis in immunosuppressed patients. In general, bilirubin less than 2 mg/dL or significant down-trending of bilirubin is required before initiation of chemotherapy. A prospective study looking at the efficacy of biliary stenting in patients with pancreatic cancer requiring neo-adjuvant therapy found high success rates in biliary decompression.20

Thus, clear-cut indications for preoperative BD in pancreatic cancer comprise unbearable symptoms (if surgery is delayed), acute cholangitis, and neo-adjuvant therapy.21 Once the decision to pursue preoperative BD is made, then multiple factors need to be addressed. The first question is deciding which method of BD to use. The considerations should include patient co-morbidities and clinical status, the anatomy of the gastrointestinal tract and biliary tree, whether a diagnosis and tissue sample is required, and finally local expertise (Fig. 1). In general, the accepted first-line intervention for BD is ERCP. This is generally done by interventional endoscopists who underwent advanced therapeutic endoscopy training. If conventional ERCP is not feasible or unsuccessful, then the second line therapies that exist include EUS-guided BD (EUS-BD) and PTC drainage by an interventional radiologist.

Modalities of Biliary Drainage

Endoscopic retrograde cholangiopancreatography

ERCP generally entails that a patient be able to undergo sedation to perform an endoscopic procedure. Depending on the center, this can include anesthesia-assistance and the use of propofol, or conscious/moderate sedation using a benzodiazepine and an opioid (such as fentanyl). A side-viewing duodenoscope is then inserted per-orally and advanced to the ampulla. Once the ampulla is reached, it can be examined through the use of the side-viewer camera to assess if there is any peri-ampullary lesion or invasion through the mucosa. Once the inspection is done, biliary access is attempted through the side-viewing endoscope. Biliary access can be done using a variety of instruments including a sphincterotome or a standard catheter. The benefit of a sphincterotome is that it comes pre-loaded with an electrosurgical cutting wire, allowing a sphincterotomy to be done to enlarge the ampullary opening. The benefit of enlarging the ampullary opening with sphincterotomy is that it improves biliary flow, relieves any congestion by allowing stones and debris to pass, and allows easier access for future cannulation attempts or endotherapy. Today most endoscopists start with a sphincterome and a guidewire rather than a standard catheter due to benefit of quicker access to the bile duct with a lower rate of complications.22 The success rate for cannulation of the biliary tree Is generally around 85 to 95% according to previous studies.23 Factors that can predispose to failure of cannulation include previous gastrointestinal surgery, volume of cases and patient factors.24

Once biliary access is established, a variety of interventions can be performed. If there is still diagnostic uncertainty, then brushings of the biliary tree may be considered. Although brushings are generally done in malignant cases, the yield of positive results is low. A recent meta-analysis demonstrated a pooled sensitivity of 45% and 48% for brushings and intra-ductal biopsies done through an ERCP.25 The side-viewing duodenoscope can also be used as a gateway to introduce other instruments through its channel. In cholangioscopy, a 10-Fr catheter with a camera at the tip can be introduced to visualize the biliary tree directly. Targeted biopsies can also be done through specific biopsy forceps through the cholangioscope. A systematic review and meta-analysis looked at the diagnostic outcomes for targeted biopsies using a single-user cholangioscopy device and found a pooled sensitivity and specificity of 60.1% and 98.0%, respectively.26 Finally, a novel and experimental technique involves the use of a probe-based confocal laser endomicroscope. In this method, a probe inserted through the endoscope with a confocal laser at the end is used to examine abnormal tissue. By using pre-determined criteria for suspicious and worrisome lesions, a previous study found a sensitivity and specificity of 100% and 71%, respectively.27

Once cannulation has been achieved, and diagnostic procedures are performed (if necessary), then biliary decompression can be pursued. Generally, this is done through the use of either a self-expanding metal stent (SEMS) or a plastic stent (Fig. 2, 3). Multiple previous studies have shown that the success rate of alleviating biliary obstruction ranges from 82% in the early studies up to greater than 90% in more recent studies. Conversely, the complication rate varies from around 11% to as high as 36% in some studies.28

Endoscopic ultrasound-guided biliary drainage

Although ERCP is generally considered the first-line therapy for biliary obstruction, it is not always successful, especially in malignant obstructions as in pancreatic cancer. Abnormal anatomy and the inability to access the ampulla are a few reasons why ERCP may not be feasible. Therefore, every ERCP should start with reviewing available cross-sectional imaging studies (CT or MRI/magnetic resonance cholangiopancreatography) and planning for alternative methods of access in preparation for possible conventional ERCP failure. Although EUS-BD is the general term regarding biliary access with the use of an echoendoscope, there are three distinct techniques; the rendezvous (RV) technique (EUS-RV), the transluminal approach, which consists with the creation of either a choledochoduodenostomy (CD) (EUS-CD) or a hepaticogastrostomy (EUS-HG), and the antegrade (AG) stent insertion approach (EUS-AG).

All three methods utilize an echoendoscope, which is used to endoscopically and sonographically visualize the biliary tree. Biliary access is established by advancing a 19 G fine needle aspiration (FNA) needle through the left hepatic duct, common hepatic duct, or common bile duct (Fig. 4, 5). Next, a guide-wire is advanced through the FNA needle into the biliary tree. In the RV method, the guidewire is fed from the bile duct through the ampulla into the duodenum; the caveat is to use a long guidewire (450 cm) and leave enough wire in the duodenum. Then, the EUS scope is switched to ERCP scope and the guidewire is grabbed by a snare in the duodenum and pulled through the therapeutic channel of the ERCP scope. The remainder of the procedure is done similar to ERCP. In the trans-mural method, a biliary-luminal fistula is created and a stent is placed in-between the biliary tree and either the stomach or duodenum. Finally, in the AG method (as compared to the retrograde ERCP method), a stent is advanced in AG fashion through the use of a guidewire, passed the obstruction and into the duodenum through the ampulla.

The evolving evidence for the utility of EUS has recently gained prominence. A 2017 systematic review and meta-analysis looked at 20 studies and 1,186 patients and found a technical success rate (defined as the successful placement of a stent) and clinical success rate (defined as a 50% reduction in bilirubin in two weeks) of 95% and 92%, respectively.29 Comparatively, the adverse event ate was only 17% in the pooled analysis. There were no differences in technical success rate between intra-hepatic and extra-hepatic ducts. Similarly, there was no differences in success rates between the two trans-mural methods (CD and HG). However, both the extra-hepatic approach and the formation of a CD resulted in less adverse events. The most common adverse events related to EUS-BD are bile leak which can occur in up to 3% of EUS patients, bleeding and cholangitis.30

Percutaneous transhepatic biliary drainage

The third commonly used approach to achieve biliary decompression in patients with obstructive jaundice is through the use of a percutaneous drain. Generally, this is done by the interventional radiology service in a radiology suite equipped with ultrasound. Through the aid of an ultrasound machine, a needle is introduced through the liver into the biliary tree, and then over a guidewire, a catheter is placed. The drainage may be internal, external or both. In internal drainage, the catheter is advance passed the ampulla into the duodenum for drainage into the lumen. For external drainage, the catheter is attached to a bag outside the patient for drainage, and for internal-external drainage, both are done. The advantage of a PTC drain is that generally it can be done with local anesthesia only and does not require sedation, which can be helpful in clinically unwell patients. The other advantage is that it does not require specialized equipment or specialized endoscopes, and can be done in the radiology suite with standard equipment, such as an abdominal ultrasound probe.

Percutaneous drainage was considered the traditional method before it was generally supplanted by ERCP as the first approach, and recently has been competing with EUS-BD as second-line salvage therapy in patients who have previously failed ERCP. Nevertheless, there are situations where percutaneous transhepatic biliary drainage (PTBD) is still considered first-line therapy, including situations where the patients’ anatomy restricts access (such as a gastric outlet obstruction) and prevents an endoscope from being used. Despite its relatively less prominent role nowadays in BD, the evidence for PTC drainage is still stellar. The technical success rate of PTC drains varies according to study but is generally considered to be greater than 90%. The clinical success rates range from 77% to 98%. The most common adverse events related to PTC drains include cholangitis, sepsis, bleeding, catheter occlusion and misplacement. The rate of adverse events ranges from anywhere between 20% to 25%, and up to a quarter of patients with PTC drains develop a recurrence of obstructive jaundice.31

Comparison

Although the general practice for preoperative BD varies by local expertise, the generally recommended algorithm starts with ERCP, which if failed, is then re-attempted by either EUS-BD or PTBD. The reason for ERCP as first-line therapy is due to its wide availability, high success rates, and relatively low complication rates. However, recent literature has challenged the role of ERCP at the head of the algorithm. A recent systematic review and meta-analysis looking at patients awaiting pancreaticoduodenectomy who were deemed to be candidates for preoperative BD, found that percutaneous drainage had significantly lower post-procedure and postoperative complications, compared to endoscopic BD. However, no difference was found in overall mortality.32 A separate meta-analysis looking at all patients with malignant biliary obstruction found no difference in overall complication or mortality rates, but showed that PTC drainage had higher technical success rates and lower rates of cholangitis. However, the study was limited by the fact that most of the included articles were retrospective in nature.33 Nevertheless, there is still controversy in this area as a separate meta-analysis found no difference in technical success rates, leading some to argue that the evidence is quite heterogeneous.34

When comparing the different types of endoscopic approaches, the use of EUS-BD has been reserved for patients that have failed ERCP. There are a variety of reasons to support this, including the novelty of EUS-BD, the lack of widespread availability and expertise, and until recently, the lack of high-quality evidence on its efficacy. However, with the rapid acceptance of EUS as a therapeutic option, there has been an influx of studies comparing its efficacy as first-line therapy. A recent prospective randomized study examined EUS-BD compared with ERCP as first-line therapy in patients with pancreatic cancer. Sixty-seven patients were randomized to either EUS-BD or ERCP and they found no significant difference in technical success rates, treatment success rates (decrease in total bilirubin to below 50% of the original value at 2 weeks post-procedure), or adverse events. Neither intervention impeded any future pancreaticoduodenectomy.35 A similar study out of Korea showed the same results; with no difference in technical success, clinical success or significant procedure-related complications.36 Although the general practice until this point still favors ERCP as first-line therapy, there is a growing literature that shows no difference with EUS-BD.

Most of the evidence in regards to EUS-BD has been as a comparison to PTBD in patients who have previously failed ERCP. A previous systematic review and meta-analysis pooled 9 studies with 483 patients and found no difference in terms of technical success, but a significant benefit favoring EUS-BD in terms of clinical success. There were also fewer adverse events in the group undergoing EUS-BD and a lower rate of re-intervention. Of note though, the review only included three studies that were randomized.37,38 In addition, a single study has demonstrated that EUS is associated with less peri-procedural pain.37

Stenting

Because malignant obstructions are not transient and do not resolve by relieving the obstructions, they generally require stenting to preserve the patency of the biliary tree. The two main options are polyethylene (i.e., plastic) stents or SEMSs. SEMS are considered to be longer lasting but come at a higher cost (Fig. 6, 7). A recent systematic review and meta-analysis looked at the outcomes of different types of stents in patients with malignant biliary obstruction. A total of 1,713 patients were included and pooled analysis found an increase in stent patency length in the patients with SEMS compared to plastic stents. The difference in the duration of stent patency was roughly 4.45 months. There were no differences in overall survival between the two stents but SEMS also resulted in less late complications, less sepsis, and less re-interventions.39

When using SEMS, the stent can be fully covered, partially covered, or uncovered. A retrospective study showed that there was no difference in overall mortality in patients with uncovered stents compared to covered stents, but the patients with covered stents had higher rates of stent migration and pancreatitis.40 A meta-analysis comparing the same two stents similarly found higher migration rates in covered stents, but also found a longer stent patency duration in patients with covered stents compared to uncovered stents.41

One area of investigation in the management of biliary obstruction is the utility of incorporating drug-eluting stents. The idea has generally been adopted from cardiovascular studies which have used drug-eluting stents to increase the duration of stent patency in patients undergoing percutaneous coronary intervention.42 A similar strategy of potentially including chemotherapy agents was devised for patients with malignant obstructions. The theoretical l benefit was the possibility of delivering drugs to the tumor without affecting systemic toxicity. Although initial animal studies using porcine bile ducts showed promising results, a pilot human study involving 21 patients was unable to show any survival benefit when using paclitaxel-incorporated metal stents compared to traditional SEMS.43,44

Conclusion

Although the overall survival rate has not improved as dramatically as desired in patients with pancreatic cancer, the tools available for BD preoperatively have drastically evolved. The prior thinking of performing biliary decompression prior to surgery has been refuted, and today preoperative BD should be reserved for patients with cholangitis or those planning to undergo neo-adjuvant chemotherapy, or whose surgery will be delayed for longer than 2 weeks. The decision about how to proceed with biliary decompression should be individualized for each patient and in accordance with local expertise. Although ERCP has traditionally being favored for drainage, the evidence of its superiority over PTBD in malignant obstructions is lacking, and the rapidly expanding and accessible EUS has shown promising results as a tool for biliary decompression. Generally, SEMS should be favored over plastic stents and uncovered stents favored over covered stents in neoadjuvant therapy. In conclusion, the care of patients with pancreatic cancer is multi-disciplinary and the role of the gastroenterologists continue to grow.

Conflicts of Interest

No potential conflict of interest relevant to this article was reported.

Figures
Fig. 1. Pancreatic adenocarcinoma infiltrating through the ampulla.
Fig. 2. Plastic biliary stent.
Fig. 3. Self-expanding metal stent.
Fig. 4. Endoscopic ultrasound-guided cholangiogram.
Fig. 5. Endoscopic ultrasound-guided cholangiogram of common bile duct.
Fig. 6. Self-expanding biliary metal stent.
Fig. 7. Self-expanding biliary metal stent (endoscopic view).
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