Endoscopic ultrasound-guided biliary drainage using a lumen-apposing self-expanding metal stent: a case series

• Introduction
• Case series
• Results
• Discussion
• References

Endoscopic ultrasound-guided biliary drainage (EUS-BD) might be an alternative to percutaneous or transpapillary biliary drainage in unresectable pancreatic or biliary cancer. A lumen-apposing, fully covered, self-expanding metal stent, which creates a sealed transluminal conduit between the biliary and gastrointestinal tract may offer advantages over conventional plastic and metal stents. In this retrospective, observational, open-label case study, five patients underwent EUS-BD for obstructive jaundice in pancreatic cancer (n = 4) or distal cholangiocarcinoma (n = 1). Technical and functional success was achieved in all patients without complications. The development of specialized stent and delivery systems may render EUS-BD an effective and safe alternative to percutaneous or transpapillary approaches.

Introduction

Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been reported to be an effective alternative technique to percutaneous transhepatic biliary drainage [1]. Once EUS-guided biliary access is established, direct biliary drainage is feasible and might offer advantages over transpapillary rendezvous approaches [2] [3]. A new fully covered, self-expanding metal stent (SEMS) [4], which allows the creation of a sealed transluminal conduit between the biliary and gastrointestinal tract may reduce the risk of stent migration and biliary peritonitis.

Case series

Patients with malignant obstructive jaundice in whom transpapillary drainage had failed were treated with EUS-BD between June 2013 and April 2014. Endoscopic retrograde cholangiopancreatography (ERCP) had failed in all patients because the papilla was inaccessible or cannulation of the CBD was not possible because of malignant duodenal stenosis or tumor infiltration of the papilla. Causes of obstructive jaundice were pancreatic cancer (n = 4) and distal cholangiocarcinoma (n = 1).

All patients were given a prophylactic dose of intraveneous antibiotics before the procedure. Patients were deeply sedated with midazolam and propofol.

The lumen-apposing stent (AXIOS; Xlumena Inc., Mountain View, California, USA) is a fully silicone-covered, nitinol-braided SEMS with bilateral anchor flanges and is delivered through a 10.5-Fr catheter. In three of the five patients, a cautery equipped device (hot AXIOS) was used. This device enables access and stent placement in one step using electrocautery for penetration of the wall, thereby obviating the need for wire exchange and dilation steps. The selection of the stent length was determined by the thickness of the interposed tissue.

To perform EUS-BD, the common bile duct (CBD) was imaged from the duodenal bulb at a frequency of 7.5 MHz using a convex echoendoscope (GF-UGT260; Olympus Optical Co. Ltd., Tokyo, Japan) connected to an ultrasound device (SSD5500; Aloka, Tokyo, Japan). The puncture of the CBD was carried out using a 19-gauge needle (EchoTip Ultra; Cook Medical, Limerick, Ireland) using real-time ultrasound and color Doppler imaging. Iodine contrast medium was injected to obtain fluoroscopic images of the biliary tree. A 0.035-inch guidewire (Jagwire; Boston Scientific, Marlborough, Massachusetts, USA) was inserted and positioned in the CBD, and then the 19-gauge needle was removed.

The preloaded stent was advanced over the wire into the CBD either after step-wise dilation (5, 7, 10 Fr, dilation catheter; MTW, Wesel, Germany; and 4-mm biliary balloon; MaxForce, Boston Scientific) or using direct cautery (AUTOCUT mode, effect 5; ERBE Electrosurgery, Tübingen, Germany). The electrosurgery mode enabled passage of the stent catheter with low device pressure, thereby facilitating continuous CBD imaging on EUS. After placement of the stent tip in the CBD, the distal flange of the stent was deployed under EUS and fluoroscopy guidance, followed by proximal traction of the distal flange to place the target lumen in firm apposition to the duodenal wall. The proximal flange was then deployed under endoscopic or EUS guidance. Finally, the stent position was verified by endoscopic view and fluoroscopy. [Fig. 1] and [Fig. e2] (available online) show the key stages of the EUS-BD technique.

Data analysis was approved by the ethics committee of the Medical Faculty of Technical University Dresden (#EK 12012014).

Results

Demographic and clinical data for the five patients are presented in [Table 1]. The approach for EUS-BD was made through the duodenal bulb to create the choledochoduodenostomy. Stents were deployed without procedure-related complications in all cases. In patient #2, the distal flange release failed technically, and the stent system was exchanged over the guidewire for a second system. Biliary drainage was technically successful in all patients (i. e. stents were deployment in the correct position). No signs of peritonitis were observed in any patient.

Clinical success was defined as a decrease in bilirubin concentration to less than 75 % of the pretreatment value within the first month and was achieved in all patients. In one patient, removal of the stent was necessary after 24 days because of insufficient drainage. In this patient, tumor pressure created a valve mechanism by pushing the opposite wall of the common bile duct into the metal stent. The metal stent was removed, the stable biliodigestive fistula was dilated to 8 mm using a wire-guided balloon, and two plastic double-pigtail stents were placed.

Procedure time for the placement of the conventional lumen-apposing stent was longer (median 105 minutes) compared with the cautery equipped system (median 30 minutes, P = 0.1 Wilcox). Long intervention times in patients #1 and #2 were due to difficulties in dilation of the tract between the duodenum and CBD. In patient #1, access was lost during the maneuver and a re-puncture of the CBD was needed.

Discussion

EUS-BD and EUS-guided biliary access procedures have been developed as an alternative for patients after failed endoscopic drainage [5]. EUS-guided access may be used to create a fistula between the duodenal bulb and the distal CBD as an effective method to relieve jaundice in patients with distal biliary obstruction [6] [7]. EUS-BD has the potential to reduce the need for percutaneous or palliative surgical procedures, which are associated with significant complications and impaired quality of life in this palliative setting. Potential advantages over percutaneous transhepatic biliary drainage and surgery include: EUS-BD can be performed in the same session as the originally failed ERCP; it provides immediate internal biliary drainage without the need for external drains; the retroperitoneal location of the CBD makes it an attractive access site for patients with ascites. In contrast to ERCP, a choledochoduodenostomy is created at some distance from the tumor and may thus be less prone to tumor overgrowth.

The complication spectrum of EUS-BD includes biliary leakage, infection, and stent migration and dysfunction. Most of these complications relate to imperfections in the design of the currently available stents and the biliary access approach; the majority of reported cases utilized plastic stents, which have the disadvantages of a small lumen diameter and failure to seal the fistula against biliary leakage. Recent reports have reported the use of SEMSs [8]. Partially and fully covered SEMSs have been associated with complications that are mainly due to stent migration and shortening of the stent after placement. The use of a new design of SEMS, with a large flange at each end, could prevent stent migration and has been previously reported for this indication [9] [10].

In this case series, no leakage was observed after stent deployment, which we attribute to the lumen-to-lumen apposition provided by the flanges as well as the full silicone covering. The dilation steps before stent placement are cumbersome and prone to loss of access, because, in contrast to the situation with pancreatic pseudocysts, the walls of the CBD and duodenum are not adherent, leading to intermittent loss of echo visibility ([Video 1]), especially if the CBD wall has become hardened by previous cholangitis. The diathermy-equipped stent-delivery system provided faster access to the CBD as it eliminates the need for tract dilation ([Video 2]). If bleeding occurs during biliary access, it is controlled by stent pressure.

Although the diathermy-equipped lumen-apposing stent system provides a number of critical advantages over previous techniques, ensuring sufficient space for stent deployment of the relatively stiff 10.5-Fr system in the CBD remains a technical challenge, and thus requires careful patient selection and an experienced operator ([Video 2]).

In summary, the described EUS-BD method appears to be safe and effective, although the present study has several limitations, such as small sample size and uncontrolled design. Technical standardization and specialized equipment for EUS-BD are emerging and may result in a broader application of this technique in the future.

Competing interests: None

• References

• 1 Varadarajulu S, Hawes RH. EUS-guided biliary drainage: taxing and not ready. Gastrointest Endosc 2013; 78: 742-743
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  Search in Google Scholar
• 3 Will U, Thieme A, Fueldner F et al. Treatment of biliary obstruction in selected patients by endoscopic ultrasonography (EUS)-guided transluminal biliary drainage. Endoscopy 2007; 39: 292-295
  Search in Google Scholar
• 4 Binmoeller KF, Shah J. A novel lumen-apposing stent for transluminal drainage of nonadherent extraintestinal fluid collections. Endoscopy 2011; 43: 337-342
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• 5 Wiersema MJ, Sandusky D, Carr R et al. Endosonography-guided cholangiopancreatography. Gastrointest Endosc 1996; 43: 102-106
  Search in Google Scholar
• 6 Itoi T, Itokawa F, Sofuni A et al. Endoscopic ultrasound-guided choledochoduodenostomy in patients with failed endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2008; 14: 6078-6082
  Search in Google Scholar
• 7 Burmester E, Niehaus J, Leineweber T et al. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc 2003; 57: 246-251
  Search in Google Scholar
• 8 Park DH, Koo JE, Oh J et al. EUS-guided biliary drainage with one-step placement of a fully covered metal stent for malignant biliary obstruction: a prospective feasibility study. Am J Gastroenterol 2009; 104: 2168-2174
  CrossrefPubMedSearch in Google Scholar
• 9 Glessing BR, Mallery S, Freeman ML et al. EUS-guided choledochoduodenostomy with a lumen-apposing metal stent before duodenal stent placement for malignant biliary and duodenal obstruction. Gastrointest Endosc 2015; 81: 1019-1020
  CrossrefPubMedSearch in Google Scholar
• 10 Itoi T, Binmoeller KF. EUS-guided choledochoduodenostomy by using a biflanged lumen-apposing metal stent. Gastrointest Endosc 2014; 79: 715
  CrossrefPubMedSearch in Google Scholar

Corresponding author

• References

• 1 Varadarajulu S, Hawes RH. EUS-guided biliary drainage: taxing and not ready. Gastrointest Endosc 2013; 78: 742-743
  CrossrefPubMedSearch in Google Scholar
• 2 Hara K, Yamao K, Niwa Y et al. Prospective clinical study of EUS-guided choledochoduodenostomy for malignant lower biliary tract obstruction. Am J Gastroenterol 2011; 106: 1239-1245
  Search in Google Scholar
• 3 Will U, Thieme A, Fueldner F et al. Treatment of biliary obstruction in selected patients by endoscopic ultrasonography (EUS)-guided transluminal biliary drainage. Endoscopy 2007; 39: 292-295
  Search in Google Scholar
• 4 Binmoeller KF, Shah J. A novel lumen-apposing stent for transluminal drainage of nonadherent extraintestinal fluid collections. Endoscopy 2011; 43: 337-342
  Thieme ConnectPubMedSearch in Google Scholar
• 5 Wiersema MJ, Sandusky D, Carr R et al. Endosonography-guided cholangiopancreatography. Gastrointest Endosc 1996; 43: 102-106
  Search in Google Scholar
• 6 Itoi T, Itokawa F, Sofuni A et al. Endoscopic ultrasound-guided choledochoduodenostomy in patients with failed endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2008; 14: 6078-6082
  Search in Google Scholar
• 7 Burmester E, Niehaus J, Leineweber T et al. EUS-cholangio-drainage of the bile duct: report of 4 cases. Gastrointest Endosc 2003; 57: 246-251
  Search in Google Scholar
• 8 Park DH, Koo JE, Oh J et al. EUS-guided biliary drainage with one-step placement of a fully covered metal stent for malignant biliary obstruction: a prospective feasibility study. Am J Gastroenterol 2009; 104: 2168-2174
  CrossrefPubMedSearch in Google Scholar
• 9 Glessing BR, Mallery S, Freeman ML et al. EUS-guided choledochoduodenostomy with a lumen-apposing metal stent before duodenal stent placement for malignant biliary and duodenal obstruction. Gastrointest Endosc 2015; 81: 1019-1020
  CrossrefPubMedSearch in Google Scholar
• 10 Itoi T, Binmoeller KF. EUS-guided choledochoduodenostomy by using a biflanged lumen-apposing metal stent. Gastrointest Endosc 2014; 79: 715
  CrossrefPubMedSearch in Google Scholar

• Supplementary Material