|Year : 2020 | Volume
| Issue : 6 | Page : 369-379
Efficacy and safety of EUS biliary drainage in malignant distal and hilar biliary obstruction: A comprehensive review of literature and algorithm
Stanley Khoo1, Nhan Duc Tri Do2, Pradermchai Kongkam3
1 Department of Medicine, Gastroenterology and Hepatology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
2 Department of Endoscopy, Can Tho General Hospital, Can Tho; Department of General Surgery, Can Tho General Hospital, Can Tho, Vietnam
3 Department of Medicine, Division of Gastroenterology, Gastrointestinal Endoscopy Excellence Center, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok; Pancreas Research Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
|Date of Submission||18-Jun-2020|
|Date of Acceptance||19-Aug-2020|
|Date of Web Publication||14-Dec-2020|
Dr. Pradermchai Kongkam
Department of Medicine, Division of Gastroenterology, Gastrointestinal Endoscopy Excellence Center, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, 1873 Rama 4 Road, Pathumwan, Bangkok 10330
Source of Support: None, Conflict of Interest: None
Malignant biliary obstruction (MBO) encompasses a variety of malignancies arising from the pancreaticobiliary system. This can be divided into malignant hilar biliary obstruction (MHBO) or malignant distal biliary obstruction (MDBO) biliary obstruction to which clinical outcomes and technical considerations of various biliary drainage methods may differ. EUS biliary drainage (EUS-BD) has been increasingly influential in the management of MBO together with other familiar biliary drainage methods such as ERCP and percutaneous transhepatic biliary drainage (PTBD). Conventionally, ERCP has always been the primary choice of endoscopic biliary drainage in both MHBO and MDBO and that PTBD or EUS-BD is used as a salvage method when ERCP fails for which current guidelines recommends PTBD, especially for MHBO. This review was able to show that with today's evidence, EUS-BD is equally efficacious and possesses a better safety profile in the management of MBO and should be on the forefront of endoscopic biliary drainage. Therefore, EUS-BD could be used either as a primary or preferred salvage biliary drainage method in these cases.
Keywords: malignant hilar biliary obstruction, malignant distal biliary obstruction, hilar cholangiocarcinoma, Klatskin's tumor, perihilar cholangiocarcinoma, endosonography, EUS, ERCP, EUS-guided biliary drainage
|How to cite this article:|
Khoo S, Do ND, Kongkam P. Efficacy and safety of EUS biliary drainage in malignant distal and hilar biliary obstruction: A comprehensive review of literature and algorithm. Endosc Ultrasound 2020;9:369-79
|How to cite this URL:|
Khoo S, Do ND, Kongkam P. Efficacy and safety of EUS biliary drainage in malignant distal and hilar biliary obstruction: A comprehensive review of literature and algorithm. Endosc Ultrasound [serial online] 2020 [cited 2021 Jan 22];9:369-79. Available from: http://www.eusjournal.com/text.asp?2020/9/6/369/303354
| Introduction|| |
Malignant biliary obstruction (MBO) encompasses a variety of malignancies arising from the pancreaticobiliary system. Common causes of MBO include pancreatic ductal adenocarcinoma, cholangiocarcinoma, ampullary/duodenal adenocarcinoma, gallbladder adenocarcinoma, lymphoma, and compressive metastatic proximal lymph nodes. Of which in clinical practice, pancreatic ductal adenocarcinoma and cholangiocarcinoma are the most common.
The incidence of pancreatic cancer was the highest in Europe (7.7/100,000 people) and North America (7.6/100,000 people). This represents 2.5% of all cancers and 80% to 90% were deem unresectable at the time of diagnosis. The demographics of pancreatic cancer was also found to be similar in the Asian population as well. On the other hand, the incidence of cholangiocarcinoma are reported to be highest in the Hispanic and Asian populations (2.8–3.3/100,000). Among all the cases, proximal disease occurs in about 50%, while distal disease occurs in 40% and intrahepatic disease <10%. In Asia, intrahepatic cholangiocarcinomas accounts the highest in countries such as South Korea and Thailand while extrahepatic cholangiocarciomas occurs highest in Japan. It is to no surprise that up to 61.4% of the cases are advanced at the time of diagnosis. As a result, palliative endoscopic biliary decompression has been essential in the management of these cases.,, Current established methods of endoscopic biliary drainage are ERCP, percutaneous transhepatic biliary drainage (PTBD) and EUS biliary drainage (EUS-BD), in which ERCP and PTBD are often the preferred choices as both methods have been established for several decades.
EUS-BD is the latest endoscopic technique comparing with the aforementioned other two. Consequently, clinical information is much less than others. Nevertheless, it has become more and more interesting as it provides an added advantage of internal biliary drainage, and its complication rates are lower when time goes by together with increasing experience by endoscopists. In some centers, it has been proposed as the primary biliary drainage modality. Therefore, in this review, we will take a look at present evidence available based on current literatures in regard to various methods of EUS-BD, their efficacy and safety as well as in comparison with conventional methods of biliary drainage in the management of MBO. Specific techniques and devices used for EUS-BD will not be discussed here.
| Malignant Distal Biliary Obstruction Versus Malignant Hilar Biliary Obstruction|| |
First, MBO can be divided into malignant distal biliary obstruction (MDBO) and malignant hilar biliary obstruction (MHBO) and the reason as such was that drainage strategies and outcomes differ from one another. For MDBO, the level obstruction occurs at the common bile duct sparing the intrahepatic ducts and relieving the obstruction is usually straightforward, providing instant clinical response and for that, often a single endoscopic procedure is usually sufficient to address the problem. On the other hand, in MHBO, achieving adequate drainage can be frustrating as intrahepatic biliary obstruction can be complex and multiple to which inadequate drainage may result in life-threatening secondary cholangitis. The common classification used is the Bismuth-Corlette (BS) classification, in which Bismuth type III–IV may involve more than one segment of intrahepatic obstruction. With that, achieving adequate biliary drainage is not straightforward, which often requires drainage of more than one segment of the liver, and thus, more than one biliary drainage procedure may be needed. Moreover, to gauge the degree of biliary obstruction is often difficult in real-life clinical practice and more so in predicting adequacy of drainage. It is important to note that it has shown by achieving adequate drainage of >50% of liver segments correlates with better survival outcomes.
| EUS-Guided Biliary Drainage|| |
EUS-BD has gained momentum over recent years and plays an important role in the management of MBO. Types of EUS-guided biliary procedures include: (1) EUS-guided choledochoduodenostomy (EUS-CDS), (2) EUS-guided hepaticogastrostomy (EUS-HGS), (3) EUS-guided hepaticoduodenostomy (EUS-HDS), (4) EUS-guided rendezvous procedure (EUS-RV) (5) EUS-guided anterograde stenting (EUS-AS). Fully covered self-expandable metal stents, partially covered metal stents, plastic stents, and lumen apposing metal stents (LAMS) are usually used for EUS-BD., A hybrid partially half-covered and uncovered biliary self-expandable metallic stent (SEMS) or a 6 mm fully covered SEMS is commonly used in EUS-HGS., Indications for EUS-BD include failed ERCP, inaccessible papilla by duodenal obstruction and altered surgical anatomy. In this section, we will mainly highlight data that are relevant to the use of EUS-CDS and EUS-HGS, which are the most common methods of EUS-BD used in current clinical practice.
The advantage and disadvantages associated with EUS-BD are listed in [Table 1]. Common adverse events (AEs) associated with EUS-BD include bleeding, peritonitis, cholangitis, pneumo-peritoneum, bile leak, and stent migration or stent re-occlusion, of which bleeding is the most common of up to 11%.,, To date, there are multiple studies carried out to evaluate the use of EUS-BD in clinical practice. However, it is important to note that many of these studies at the moment were retrospective; hence, data may seem bias; furthermore, most studies were used in the management of distal biliary obstruction with little prospective data on hilar biliary obstruction.
Here, we look at the available evidence on the use of EUS-BD in MDBO. In two meta-analyses, it was revealed that the overall safety of EUS-BD, of which the technical success rate (TSR), clinical success rate (CSR), and AE were 90%–94%, 91.6%, and 16%–23%, respectively., Stent migration can be a cause of concern here with the reported risk ranging from 12% to 30.8%., Retrospective studies available have shown to have good clinical outcomes with the overall TSR, CSR, and AE ranging from 86.5% to 100%, 90%–100% and 0%–23%, respectively, though the predominant pathology was MDBO.,,, A review article evaluating the use of EUS-HGS showed that in 27 studies evaluated the TSR, CSR, and AE were 96%, 90%, and 18%, respectively. These studies were, however, predominantly retrospective studies involving MDBO and only a small number of prospective studies. Therefore, with cautious use of EUS-BD in MDBO, it can be deemed safe and clinically efficacious.
With regard to MHBO, EUS CDS would not be feasible, and hence, we look at what are the evidence available. Minaga et al. retrospectively had 30 patients with MHBO who underwent EUS-BD after failed ERCP. The TSR, CSR, and AE rates were 96.7%, 75.9%, and 10%, respectively. Moryoussef et al. prospectively recruited 18 patients who has proximal MBO for EUS-HGS. The TSR, CSR, and AE rates were 94%, 72.2%, and 16.7%, respectively. In another retrospective study by Ogura et al., 10 out of 26 patients with MHBO who needed re-intervention after ERCP underwent EUS-BD and the TSR, CSR, and AE rates were 100%, 90%, and 0%, respectively. A review article by Nakai et al. in which 11 studies of EUS-BD in MHBO found that the pooled TSR, CSR, and AEs of 11 available studies were 98%, 77%, and 8%, respectively. EUS HGS, HDS, and bridging methods were included in this review as either an initial or rescue method after failed ERCP in the treatment of MHBO. However, it is worth to note that the cohort of patients of all these studies are small and consists of a number retrospective studies, case reports, and case series. Similar to MDBO, EUS-BD is safe and efficacious when managing MHBO. The studies are summarized in [Table 1] and [Table 2].
| EUS Choledochoduodenostomy Versus EUS Hepaticogastrostomy|| |
In regard to whether EUS-CDS or EUS-HGS is preferred, there are few recent studies that show a similar excellent technical and clinical success. However, it appears that the risk of AEs is higher with EUS-HGS. The TSR, CSR, and AE were 84%–100%; 77%–100%; 9.3%–32.6% in the EUS-CDS group versus 90.4%–100%; 82.1%–100%; 9.5%–35.6% in the EUS-HGS group, respectively.,,,,,,, These studies are summarized in [Table 3].
|Table 3: Summary of studies using EUS- choledochoduodenostomy versus EUS-hepaticogastrostomy|
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The recent development of a one-step hot-cautery LAMS has made EUS-CDS a very attractive option in the management of MDBO as a one-step procedure. The TSR was reported to be 100% with a CSR of 95% with AE of 36.7%. This is in contrast to performing EUS-HGS to which the learning curve is somewhat steep and require much experience to be able to achieve the required competence, desired clinical results, and safety profile [Table 3].
| EUS-Guided Biliary Drainage Versus ERCP|| |
In comparison with ERCP in draining MDBO, EUS-BD similarly showed comparable efficacy and superior safety profile, especially lower risk of pancreatitis. The reported TSR, CSR, and AE were 93.4%–100%; 90.2%–100% and 6.3%–15% in the EUS-BD group versus 90.2%–94.2%; 91.3%–94.5%; 8.7%–24% in the ERCP group, respectively.,,, In a meta-analysis, ERCP and EUS-BD are seen as comparable in terms of CSR and AE with a significantly lower risk of pancreatitis in the EUS-BD group (0.3% vs. 7.3%).
On the other hand, in MHBO, to date there are no comparative studies between EUS-BD and ERCP in MHBO. However, when ERCP is chosen, bilateral drainage results in better clinical outcomes with lower re-intervention rates compared to unilateral drainage. In a prospective study by Lee et al. involving 133 patients with malignant hilar obstruction and comparing bilateral and unilateral groups, the TSR were 95.5% vs. 100% (P = 0.244), CSR were 95.3% vs. 84.9% (P = 0.047), early AE were 6.3% vs. 27.3% (P = 0.001). The primary re-intervention rates were also lower (P = 0.049) in the bilateral group (42.6%) compared to the unilateral group (60.3%). In a meta-analysis consisting of 9 studies involving 782 patients with malignant hilar obstruction showed that bilateral stenting had significantly lower re-intervention rate compared with unilateral drainage (odds ratio [OR] = 0.59, 95% confidence interval [CI]: 0.40–0.87, P = 0.009). In addition, there was no difference in the TSR (OR = 0.7, CI: 0.42–1.17, P = 0.17), early complication rate (OR = 1.56, CI: 0.31–7.75, P = 0.59), late complication rate (OR = 0.91, CI: 0.58–1.41, P = 0.56), and stent malfunction (OR = 0.69, CI: 0.42–1.12, P = 0.14). Needless to say, comparative studies involving EUS-BD and ERCP in MHBO are still lacking. The studies are summarized in [Table 4].
Combination of ERCP and EUS-BD (CERES) [Figure 1]a and [Figure 1]b was a novel method which appears to be a feasible alternative to PTBD in the treatment of MHBO with Bismuth type III–IV disease., This attractive option is based on the principles that internal drainage is much more desirable and alleviate the high complication and morbidity rates of using PTBD. A recent multicenter observation open-label study comparing CERES versus PTBD techniques for MHBO showed that the overall TSR, CSR, and complication rates of CERES versus PTBD were 84.2% (16/19) versus 100% (17/17) (P = 0.23), 78.9% (15/19) versus 76.5% (13/17) (P = 1), and 26.3 (5/19) versus 35.3 (6/17) (P = 0.56), respectively. Within 3 and 6 months, recurrent biliary obstruction rates of CERES versus PTBD were 26.7% (4/15) versus 88.2% (15/17), P = 0.001, and 22.2% (2/9) versus 100% (9/9), P = 0.002, respectively. More studies will be needed to further evaluate the clinical use and safety of this technique [Table 4] and [Figure 1]a, [Figure 1]b.
|Figure 1: (a) EUS-hepaticogastrostomy to left intrahepatic duct combined with ERCP to the right intrahepatic duct. (b) EUS-hepaticoduodenostomy to right intrahepatic duct combined with ERCP to the right intrahepatic duct.|
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|Figure 2: Proposed algorithm for EUS-BD in unresectable malignant biliary obstruction. AS: Anterograde stenting; CDS: Choledochoduodenostomy; EUS-BD: EUS-guided biliary drainage; CERES: Combined ERCP and EUS.BD; HGS: Hepaticogastrostomy; RV: Rendezvous procedure|
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| EUS-Guided Biliary Drainage Versus Percutaneous Transhepatic Biliary Drainage|| |
In comparing EUS-BD and PTBD in the management of MDBO, several prospective and retrospective studies have showed comparable technical and clinical success with a lower rate of AEs favoring EUS-BD when comparing these two modalities of biliary drainage. These studies were predominantly single center, retrospective studies with a relatively small cohort of patients, the reported TSR, CSR and AE of 86.4%–100%; 62.2%–100%; 6.6%–15.3% in the EUS-BD group versus 46%–100%; 46%–100%; 25%–53.8% in the PTBD group, respectively.,,,,, In a latest prospective multi-center randomized controlled trial (RCT), Lee et al. strengthen this argument in that EUS-BD has similar clinical efficacy with lower complications compared to PTBD. In a meta-analysis conducting nine studies with 483 patients, it showed that there is no difference in technical success between EUS-BD versus PTBD group (OR: 1.78; 95% CI: 0.69–4.59; I2 = 22%). However, the EUS-BD group was associated with better clinical success (OR: 0.45; 95% CI: 0.23–0.89; I2 = 0%), fewer postprocedure AEs (OR: 0.23; 95% CI: 0.12–0.47; I2 = 57%), and lower rate of reintervention (OR: 0.13; 95% CI: 0.07–0.24; I2 = 0%). This again showed that EUS-BD should be the method of choice over PTBD when ERCP fails. As stated previously, the only study available that compared the use of EUS-BD and PTBD in MHBO showed that EUS-BD is as efficacious with lower rates of recurrent biliary obstruction. Available studies are summarized in [Table 5].
|Table 5: Summary of studies using EUS - biliary drainage versus percutaneous transhepatic biliary drainage|
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| EUS Rendezvous Procedure|| |
EUS Rendezvous Procedure (EUS-RV) was first described in 2004 by Mallery et al. EUS-RV is indicated as a salvage technique for failed biliary cannulation during ERCP even which was performed by a skilled endoscopist. Available studies at present are mostly retrospective studies involving MDBO. Dhir et al. concluded that EUS-RV was found to be superior to precut papillotomy for single-session biliary access with a success rate of 98.3% versus 90.3%; P = 0.03. The overall technical successful rate of EUS-RV across some studies were >80%.,, Both intrahepatic and extrahepatic approaches are feasible with varying degrees of success from 44% to 82%.,,,, The incidences of AEs were 10%–23%. The major complications were bleeding, bile leakage, peritonitis, pneumoperitoneum, pancreatitis, and mediastinitis.,, Some argued that intrahepatic access is preferred due to the lower risk of bile leakage., The major disadvantage of EUS-RV is that it involves a two-step procedure. The available studies are summarized in [Table 6].
| EUS Anterograde Stenting|| |
EUS-AS is useful in patients who have altered anatomy or presence of duodenal obstruction and is only applicable to MDBO. In reported small retrospective studies, the overall success rate ranges from 60% to 85%, with complication rates from 0% to 15%. Cholangitis, stent occlusion, and migration are among the complications reported., Available studies similar to EUS-RV are rather limited.
| Application Of EUS-Guided Biliary Drainage and Proposed Algorithm in Real Life Clinical Practice|| |
With the evidence presented in the above sections, how could we possibly incorporate the different methods of biliary drainage in today's landscape of managing MBO. To this day, EUS-BD has been seen as a salvage method of biliary drainage compared to ERCP and PTBD. Its availability vastly depends on the facilities and expertise available in their own respective clinical setting. Nonetheless, ERCP and PTBD have always been the preferred method of drainage compared to EUS BD. Whether ERCP or PTBD is more superior than another is still debatable and there are contrasting evidence to this. In a retrospective study, ERCP has resulted in better safety profile and clinical outcomes compared to PTBD even in centers who performs high volume of PTBD procedures. However, there are some advantages of PTBD such as requiring minimal sedation, facilitating precise lobar selection, and reducing the risk of exposing the biliary tree to duodenal contents. In spite of that, the complications of PTBD are reported to be as high as 53.2% and this includes septicemia, cholangitis, bleeding, electrolyte lost, leakage, wound infection, and local discomfort. Recent meta-analyses revealed that though PTBD and ERCP achieved similar results in terms of clinical outcomes, PTBD was associated with lower AEs and better safety profile compared to ERCP. The CSR and AEs of PTBD ranges from 61% to 93.9% and 12.9%–67%, respectively., Hence, one could possibly argue that some may prefer PTBD over ERCP or when ERCP fails or is contraindicated, though by majority standards, ERCP has always been the primary choice whenever possible.
With the above considerations and conflicts surrounding the different mode of biliary drainage in daily practice, it reinforces the need to look at the application of EUS-BD in clinical practice as a modality of biliary drainage in unresectable MBO. In addition, there are no clear guidelines at the moment on how these methods can be used in different levels of MBO.
Major guidelines recommend ERCP as the primary choice of biliary drainage in MDBO. SEMSs are often preferred for this purpose. PTBD is then used when ERCP fails., Therefore, ERCP remains the first modality used in biliary drainage for MDBO, and current guidelines do advocate that PTBD or EUS-BD will be considered if ERCP fails.,, However, at this point, with the data presented in the earlier sections, we do recommend that EUS-BD should be preferred over PTBD.
Feasible options available for EUS-guided interventions for unresectable MDBO include: (1) EUS-BD (CDS or HGS), (2) EUS-RV, and (3) EUS-AS. However, there are a number of scenarios to be considered when deciding the choice of EUS-BD. First, whether there is the presence of duodenal obstruction, the accessibility of the papilla or the presence of a surgically altered anatomy. Second, whether the level of the distal biliary obstruction is high or low. EUS-CDS, for example, will not be possible in high-level MDBO due to difficulty in executing interventional procedures at the proximal common bile duct. With that together with the similar clinical efficacy and superior safety profile of EUS-BD over PTBD, EUS-BD should be the preferred mode of biliary drainage compare to PTBD in the event ERCP fails or any contraindication to ERCP in MDBO. Whether primary EUS-BD should be advocated over ERCP is still yet to be seen. Although this option appears to be safe and promising, more studies will be needed to evaluate this.
With regard to MHBO, biliary drainage is much more complex as mentioned previously. Bismuth type III and IV disease remains to be more challenging than type I–II as often to attain adequate clinical success, it involves draining more than one segment of the liver. Whenever possible, bilateral stenting by ERCP is better than unilateral stenting. Having said that, adequate biliary drainage may not be optimal in Bismuth Type III–IV and together with the difficulty of ERCP, the risk of contrast-induced cholangitis will invariably be increased. In a retrospective study showed that percutaneous self-expandable metal stents is preferred over endoscopic technique owing to a higher success rate and lower AEs in Bismuth type III–IV disease. Currently, a RCT is still being conducted to compare PTBD and ERCP in the management of MHBO. At this juncture, the Asia-Pacific Consensus and ESGE guidelines recommend PTBD over ERCP in MHBO of Bismuth type III–IV disease and ERCP over PTBD in Bismuth type II disease.,
Feasible options available for EUS-guided interventions for unresectable MHBO include: (1) EUS-HGS, (2) EUS-HDS, (3) Bridging method with (EUS-HGS/HDS), (4) CERES, and (5) EUS-RV (6) EUS-AS. Evidence pertaining the EUS-BD as the primary method for biliary drainage in MHBO is still scarce at the moment. Similar to the management of MDBO, EUS-BD should be considered over PTBD if ERCP is not feasible. This is to maximize the probability of achieving optimal biliary drainage with minimal risk of cholangitis. Although studies that directly compare EUS-BD with PTBD or ERCP in the management of unresectable MHBO are still very much limited at the moment, the undesirable higher complications rate seen in PTBD as mentioned previously alone may reinforce the notion that EUS-BD should be the preferred option in such circumstance. Despite this, studies regarding the use of EUS-BD as a primary choice of drainage modality in MHBO is still very much needed to ascertain its recommendation. From the patients' point of view, it has been shown that internal drainage is more preferable than external drainage. A multicenter survey conducted looking at whether patients preference between EUS-BD or PTBD revealed that >80% preferred EUS-BD over PTBD. The reasons were less physical discomfort without percutaneous drain tube placement (78.1%), a higher success rate with relatively lower morbidity (43.8%), and the ability to be performed at the same time as the ERCP (28.3%).
Even though there are strong reasons to use EUS-BD in the forefront of today's clinical practice, limitations to the application of EUS-BD is still a common obstacle in that only limited centers have the capabilities to perform such procedures. Only in high volume centers where advanced therapeutic EUS expertise are available then only EUS-BD will be performed. The complexity and difficulty of the procedure further limit its use in daily practice. As a result, in the vast majorities of centers where EUS expertise are not available, ERCP and PTBD are still the preferred choices of biliary drainage in MBO. A proposed algorithm of the position of EUS-BD in practice is shown in [Figure 2].
| Conclusion|| |
Interventional EUS has come a long way over the years, and the contribution of their role to the management of pancreaticobiliary diseases has been increasingly important. We believe that with the current evidence available as discussed above, EUS-BD together with ERCP and not PTBD should be the preferred method of biliary drainage in the management of MBO and it has proven to be comparable or more efficacious and most of all safer. Unless in patients who has a poor expected survival time of <3 months or those who has poor functional status or unfit for endoscopic drainage, the use of PTBD should otherwise be discouraged. In addition, with the continuous development of improved stents such as the one-step hot-cautery LAMS and EUS-BD-specific endoscopic accessories, the choice and importance of EUS-BD cannot be overemphasized.
Further prospective randomized studies will be needed to explore not only the benefits of EUS-BD and the possibility of it being the primary choice of biliary drainage in MBO, especially in MHBO but also to look at optimum devices, techniques, and ways to minimize the complication rates of EUS-BD.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]