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Biliary Stenting for Unresectable Malignant Biliary Obstruction Endoscopic ultrasonography-guided cholecystogastrostomy using a lumen-apposing metal stent as an alternative to extrahepatic bile duct drainage in pancreatic cancer with duodenal invasion Takao Itoi, 1,† Kenneth Binmoeller, 2,† Fumihide Itokawa, 1 Junko Umeda 1 and Reina Tanaka 1 1 Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan; and 2 Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA Various approaches to biliary drainage, especially endoscopic ultrasonography (EUS)-guided drainage, have become commonly used as an alternative method for biliary decompression for malignant biliary obstruction. Occasionally, however, duodenal obstruction and non-dilated intrahepatic bile duct impede con- ventional EUS-guided biliary drainage. Herein, we describe a case of cholecystogastrostomy successfully carried out using a newly developed fully covered lumen-apposing self-expandable metallic stent (SEMS). EUS-guided cholecystogastrostomy should be considered an option for biliary decompression. This is a particularly ideal alternative if the patient has duodenal strictures with or without a duodenal metal stent and a non-dilated intra- hepatic bile duct, which suggests the impossibility of choledoch- oduodenostomy and hepaticogastrostomy. Furthermore, the newly developed fully covered lumen-apposing SEMS seems ideal for EUS-guided cholecystoenterostomy. Key words: endoscopic ultrasonography (EUS), gallbladder drainage, lumen-apposing self-expandable metallic stent (SEMS) INTRODUCTION C URVED LINEAR-ARRAY ECHOENDOSCOPES are very useful not only as diagnostic tools for endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA) but also as therapeutic strategy-deciding instruments. In terms of therapeutic EUS, recently, EUS-guided drainage (e.g. pancreatic pseudocyst drainage, 1 biliary drainage, 2 and gallbladder drainage 3,4 ) has been widely carried out by expe- rienced endoscopists. Among these EUS-guided drainage procedures, biliary drainage has frequently been used as an alternative method of biliary decompression for malignant biliary obstruction. EUS-guided extrahepatic bile duct drain- age and EUS-guided intrahepatic bile duct drainage, as represented by choledochoduodenostomy and EUS-guided hepaticogastrostomy, respectively, are commonly used. However, at times, duodenal obstruction and a non-dilated intrahepatic bile duct hinder the performance of conven- tional EUS-guided biliary drainage. Herein, we describe a case of cholecystogastrostomy successfully carried out using a newly developed fully covered lumen-apposing self- expandable metallic stent (SEMS). 5 CASE REPORT A 57-YEAR-OLD MAN with cancer of the head of the pancreas and with a pancreatic pseudocyst as a result of disruption of the pancreatic duct presented with obstructive jaundice. Direct bilirubin was 9.4 mg/dL and he had high fever and vomiting as a result of distal biliary obstruction and duodenal obstruction caused by cancer invasion in the first and second portions of the duodenum. As the duodeno- scope could not reach the papilla, we planned simultaneous double stenting using a duodenal stent from the pylorus ring to the second portion of the duodenum and a biliary metal stent for hepaticogastrostomy. Preprocedural magnetic reso- nance cholangiopancreatography showed a mildly dilated and distorted left intrahepatic bile duct, suggesting that large-bore metal stent placement was not appropriate and Corresponding: Takao Itoi, Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan. Email: [email protected] AXIOS stents used in the present study were provided free of charge by Xlumena Inc. (Mountain View, CA, USA). Takao Itoi holds consult- ant and advisory board positions with Xlumena Inc., and Kenneth Binmoeller is Chief Medical Officer for, and a stockholder in, Xlumena Inc. Received 28 November 2012; accepted 6 February 2013. Digestive Endoscopy 2013; 25 (Suppl. 2): 137–141 doi: 10.1111/den.12084 © 2013 The Authors Digestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society 137
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Page 1: Endoscopic ultrasonography-guided cholecystogastrostomy using a lumen-apposing metal stent as an alternative to extrahepatic bile duct drainage in pancreatic cancer with duodenal invasion

Biliary Stenting for Unresectable Malignant Biliary Obstruction

Endoscopic ultrasonography-guidedcholecystogastrostomy using a lumen-apposing metal stentas an alternative to extrahepatic bile duct drainage inpancreatic cancer with duodenal invasion

Takao Itoi,1,† Kenneth Binmoeller,2,† Fumihide Itokawa,1 Junko Umeda1 and Reina Tanaka1

1Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan; and 2InterventionalEndoscopy Services, California Pacific Medical Center, San Francisco, California, USA

Various approaches to biliary drainage, especially endoscopicultrasonography (EUS)-guided drainage, have become commonlyused as an alternative method for biliary decompression formalignant biliary obstruction. Occasionally, however, duodenalobstruction and non-dilated intrahepatic bile duct impede con-ventional EUS-guided biliary drainage. Herein, we describe acase of cholecystogastrostomy successfully carried out using anewly developed fully covered lumen-apposing self-expandablemetallic stent (SEMS). EUS-guided cholecystogastrostomy shouldbe considered an option for biliary decompression. This is a

particularly ideal alternative if the patient has duodenal strictureswith or without a duodenal metal stent and a non-dilated intra-hepatic bile duct, which suggests the impossibility of choledoch-oduodenostomy and hepaticogastrostomy. Furthermore, thenewly developed fully covered lumen-apposing SEMS seemsideal for EUS-guided cholecystoenterostomy.

Key words: endoscopic ultrasonography (EUS), gallbladderdrainage, lumen-apposing self-expandable metallic stent (SEMS)

INTRODUCTION

CURVED LINEAR-ARRAY ECHOENDOSCOPES arevery useful not only as diagnostic tools for endoscopic

ultrasonography-guided fine-needle aspiration (EUS-FNA)but also as therapeutic strategy-deciding instruments. Interms of therapeutic EUS, recently, EUS-guided drainage(e.g. pancreatic pseudocyst drainage,1 biliary drainage,2 andgallbladder drainage3,4) has been widely carried out by expe-rienced endoscopists. Among these EUS-guided drainageprocedures, biliary drainage has frequently been used as analternative method of biliary decompression for malignantbiliary obstruction. EUS-guided extrahepatic bile duct drain-age and EUS-guided intrahepatic bile duct drainage, asrepresented by choledochoduodenostomy and EUS-guided

hepaticogastrostomy, respectively, are commonly used.However, at times, duodenal obstruction and a non-dilatedintrahepatic bile duct hinder the performance of conven-tional EUS-guided biliary drainage. Herein, we describe acase of cholecystogastrostomy successfully carried out usinga newly developed fully covered lumen-apposing self-expandable metallic stent (SEMS).5

CASE REPORT

A 57-YEAR-OLD MAN with cancer of the head of thepancreas and with a pancreatic pseudocyst as a result of

disruption of the pancreatic duct presented with obstructivejaundice. Direct bilirubin was 9.4 mg/dL and he had highfever and vomiting as a result of distal biliary obstructionand duodenal obstruction caused by cancer invasion in thefirst and second portions of the duodenum. As the duodeno-scope could not reach the papilla, we planned simultaneousdouble stenting using a duodenal stent from the pylorus ringto the second portion of the duodenum and a biliary metalstent for hepaticogastrostomy. Preprocedural magnetic reso-nance cholangiopancreatography showed a mildly dilatedand distorted left intrahepatic bile duct, suggesting thatlarge-bore metal stent placement was not appropriate and

Corresponding: Takao Itoi, Department of Gastroenterology andHepatology, Tokyo Medical University, 6-7-1 Nishishinjuku,Shinjuku-ku, Tokyo 160-0023, Japan. Email: [email protected]†AXIOS stents used in the present study were provided free of chargeby Xlumena Inc. (Mountain View, CA, USA). Takao Itoi holds consult-ant and advisory board positions with Xlumena Inc., and KennethBinmoeller is Chief Medical Officer for, and a stockholder in, XlumenaInc.Received 28 November 2012; accepted 6 February 2013.

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Digestive Endoscopy 2013; 25 (Suppl. 2): 137–141 doi: 10.1111/den.12084

© 2013 The AuthorsDigestive Endoscopy © 2013 Japan Gastroenterological Endoscopy Society

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that stent patency would be inadequate due to possiblekinking of the edge of the stent within the bile duct. Thus,before the duodenal stenting, EUS-guided cholangiographywas done using a 22-gauge needle (Fig. 1). The puncture wasconducted through the B3 intrahepatic bile duct because of anon-dilated B2 intrahepatic bile duct and possible transe-sophageal puncture. In addition, angulation of the needle tothe intrahepatic bile duct seemed too acute to place the metalstent safely. Interestingly, EUS-guided cholangiography

showed that the gallbladder communicated well with theextrahepatic bile duct. Therefore, EUS-guided gallbladderdrainage was considered an option for biliary decompressionif the duodenal stent did not interfere with the gallbladderstent. We obtained informed consent for EUS-guided gall-bladder drainage after discussing the risks, benefits, andalternatives with the patient and his family.

First, a duodenal metal stent (WallFlex®; Boston ScientificJapan, Tokyo, Japan) was placed across the pyloric ring(Fig. 2). Fortunately, as EUS transgastrically depicted thegallbladder as having no interference from the prior duodenalstent (Fig. 3a), EUS-guided cholecystogastrostomy wascarried out using a lumen-apposing metal stent (AXIOS stent;Xlumena Inc., Mountain View, CA, USA), which is a fullycovered, 10-mm diameter, 10-mm long, nitinol, braided stentwith bilateral 20-mm diameter anchor flanges (Fig. 4).Briefly, a 19-gauge needle (EchoTip; Cook Endoscopy,Winston-Salem, NC, USA) was inserted transgastrically intothe extrahepatic bile duct under EUS visualization (Fig. 3b).6

After the stylet was removed, bile was aspirated and contrastmedium was injected into the gallbladder. A 450-cm long,0.025-inch guidewire (VisiGlide®; Olympus MedicalSystems, Tokyo, Japan) was inserted into the outer sheath(Fig. 5). Following this, the insertion of a bougie by standardendoscopic retrograde cholangiopancreatography (ERCP)injection catheter (ERCP catheter; MTW Endoscopie, Düs-seldorf, Germany), a 4-mm diameter dilating balloon (Hurri-cane; Boston Scientific Japan) was used to dilate the tract.Finally, cholecystogastrostomy was carried out using anAXIOS stent without any adverse events (Fig. 6). The patientrecovered well and laboratory data the following day showedimprovement of liver function. At present, 1 year later,the AXIOS stent in the gallbladder is still patent with nosymptoms.

Figure 1 Endoscopic ultrasonography-guided cholangiographyusing a 22-gauge needle. Cystic duct clearly communicates withthe bile duct.

a b

Figure 2 Duodenal metal stent wasplaced from the pylorus ring to thesecond portion of the duodenum. (a)X-ray image. (b) Endoscopic image.

138 T. Itoi et al. Digestive Endoscopy 2013; 25 (Suppl. 2): 137–141

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DISCUSSION

CURRENTLY, EUS-GUIDED BILIARY drainage is anoption for biliary decompression. In general, EUS-

guided biliary drainage is divided into EUS-guided choledo-choduodenostomy for extrahepatic bile duct drainage, andEUS-guided hepaticogastrostomy for intrahepatic bile duct

drainage. In the present case, EUS-guided hepaticogastros-tomy seemed a standard technique of EUS-guided biliarydrainage. However, current angulation of the needle to theintrahepatic bile duct seemed too acute to place the metal stentsafely. Based on our experience, inappropriate metal stentplacement for EUS-guided hepaticogastrostomy causesstent migration and dysfunction, leading to unnecessary

a b

Figure 3 Transgastric echoendoscopic images. (a) Endoscopic ultrasonography depicts the gallbladder. (b) A 19-gauge needle wasadvanced into the gallbladder.

Figure 4 AXIOS stent (Xlumena Inc., Mountain View, CA, USA) isa fully covered, 10-mm diameter, 10-mm long, nitinol, braidedstent with bilateral 20-mm diameter anchor flanges.

Figure 5 A 0.025-inch guidewire was looped in the gallbladder.

Digestive Endoscopy 2013; 25 (Suppl. 2): 137–141 EUS-guided cholecystogastrostomy 139

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complications. In addition, EUS-guided cholangiographyshowed that the gallbladder communicated well with theextrahepatic bile duct. Thus, we selected EUS-guided chole-cystogastrostomy instead of EUS-guided hepaticogastros-tomy. Fortunately, we demonstrated that gallbladder drainageincluding cholecystogastrostomy and cholecystoduodenos-tomy can serve as an alternative procedure for bile ductdrainage if the cystic duct takes off above the strictures, andthe bile duct and gallbladder communicate well with eachother. If, in fact, it is difficult to puncture the non-dilatedintrahepatic bile duct in the percutaneous transhepatic biliarydrainage procedures in patients with distal biliary strictures orbile duct stones, percutaneous transhepaticgallbladder drainage is conducted instead of bile ductdrainage. Until now, surprisingly, no obvious stent occlusionhas occurred. These results suggest that EUS-guided cho-lecystoenterostomy may be an option for bile duct dra-inage, particularly when double stenting for EUS-guidedcholedochoduodenostomy and hepaticogastrostomy are dif-ficult or impossible.

Because the gallbladder and stomach or duodenum do notadhere to each other, drainage of the gallbladder carries arisk of leakage of bile or enteric contents within the gallblad-der. In the present case, we did not observe leakage afterdeployment of the stent and we attribute this to the lumen-to-lumen apposition provided by the flanges as well as thefull-silicone covering. Previously, because we have encoun-tered bile leakage during EUS-guided cholecystoenteros-tomy using a double pig-tail plastic stent,3 we advocated that,among endoscopic approaches, further research was neededregarding the EUS-guided approach to the gallbladder,including the indication and standardization of the proce-dure. We now believe that this procedure cannot be safely

recommended. However, dedicated devices such as theAXIOS stent allow safe and reliable therapeutic EUS.4,7

EUS-guided cholecystogastrostomy for decompression ofthe bile duct is suitable in the following situations: (i) distalbiliary obstruction; (ii) the cystic duct takes off above thestrictures and the bile duct and gallbladder communicatewell with each other; (iii) duodenal obstruction that requiresa duodenal stent; and (iv) inappropriate EUS-guided hepat-icogastrostomy as a result of a non-dilated intrahepatic bileduct and/or acute angulation of needle puncture for the metalstent placement.

In conclusion, EUS-guided cholecystogastrostomy shouldbe considered as an option for biliary decompression. Inparticular, when a patient has a duodenal stricture, with orwithout a duodenal metal stent, and a non-dilated intrahe-patic bile duct suggesting choledochoduodenostomy andhepaticogastrostomy are not possible, it may be an idealalternative. Furthermore, the newly developed fully coveredlumen-apposing metal stent would appear to be ideal forEUS-guided cholecystoenterostomy.

ACKNOWLEDGMENTS

WE ARE INDEBTED to Professor James M. Varda-man, Associate Professor Edward Barroga, and Pro-

fessor J. Patrick Barron, Chairman of the Department ofInternational Medical Communications at Tokyo MedicalUniversity for their editorial review of the manuscript.

CONFLICT OF INTERESTS

THE AXIOS STENTS were provided free of charge byXlumena Inc. (Mountain View, CA, USA). Takao Itoi

holds consultant and advisory board positions with Xlumena

a b

Figure 6 AXIOS stent deployment(Xlumena Inc., Mountain View, CA,USA). (a) X-ray image. (b) Endoscopicimage.

140 T. Itoi et al. Digestive Endoscopy 2013; 25 (Suppl. 2): 137–141

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Inc., and Kenneth Binmoeller is Chief Medical Officer for,and a stockholder in, Xlumena Inc. Fumihide Itokawa, JunkoUmeda, and Reina Tanaka declare no conflict of interests forthis article.

REFERENCES

1 Seewald S, Ang TL, Richter H et al. Long-term results afterendoscopic drainage and necrosectomy of symptomatic pancre-atic fluid collections. Dig. Endosc. 2012; 24: 36–41.

2 Itoi T, Sofuni A, Itokawa F et al. Endoscopic ultrasonography-guided biliary drainage. J. Hepatobiliary Pancreat. Sci. 2010; 17:611–6.

3 Itoi T, Itokawa F, Kurihara T. Endoscopic ultrasonography-guided gallbladder drainage: Actual technical presentations andreview of the literature (with videos). J. Hepatobiliary Pancreat.Sci. 2011; 18: 282–6.

4 Itoi T, Binmoeller KF, Shah J et al. Clinical evaluation of a novellumen-apposing metal stent for endosonography-guided pancre-atic pseudocyst and gallbladder drainage (with video). Gas-trointest. Endosc. 2012; 75: 870–6.

5 Itoi T, Coelho-Prabhu N, Baron TH. Endoscopic gallbladderdrainage for management of acute cholecystitis. Gastrointest.Endosc. 2010; 71: 1038–45.

6 Itoi T, Isayama H, Sofuni A et al. Stent selection and tips onplacement technique of EUS-guided biliary drainage: Trans-duodenal and transgastric stenting. J. Hepatobiliary Pancreat.Sci. 2011; 18: 664–72.

7 Jang JW, Lee SS, Park do H et al. Feasibility and safety ofEUS-guided transgastric/transduodenal gallbladder drainagewith single-step placement of a modified covered self-expandablemetal stent in patients unsuitable for cholecystectomy. Gas-trointest. Endosc. 2011; 74: 176–81.

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