Double endoscopic bypass by using lumen-apposing stents (with videos)

Double endoscopic bypass by using lumen-apposing stents (with videos)

THINKING OUTSIDE THE BOX Double endoscopic bypass by using lumen-apposing stents (with videos) Although EUS started as a purely diagnostic modality, ...

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THINKING OUTSIDE THE BOX

Double endoscopic bypass by using lumen-apposing stents (with videos) Although EUS started as a purely diagnostic modality, it has been used more frequently for therapeutic purposes in recent years,1 including drainage of pancreaticobiliary ducts and EUS-guided gastroenterostomy (EUS-GE).2-5 Patients with periampullary cancer may present with both biliary obstruction and gastric outlet obstruction (GOO) and frequently have unresectable disease.6 Traditionally, a double surgical bypass was performed with surgical choledochojejunostomy and GE for palliative purposes. This approach is invasive and associated with nontrivial morbidity and mortality.7 A total endoscopic approach for palliation of patients with simultaneous biliary obstruction and GOO is ideal because it offers a minimally invasive means for management of these difficult-to-treat patients. EUS offers direct access to the biliary system through the duodenum via choledochoduodenostomy (EUS-CDS) or the stomach via hepatogastrostomy (EUS-HGS).8 Multiple studies have reported on the efficacy and safety of EUS-guided biliary drainage (EUS-BD).9 Similarly, EUS provides direct access to a small bowel loop distal to the duodenal obstruction site for creation of EUS-GE.5 The recent advent of lumen-apposing stents (LASs) has facilitated easier access and drainage of the biliary system and rendered EUS-GE feasible.10 LASs result in formation of an endoscopic anastomosis between 2 lumens, which minimizes adverse events such as leakage.11,12 Herein, we describe a patient with biliary obstruction and GOO who underwent simultaneous EUS-BD and EUS-guided gastrojejunostomy and propose a total endoscopic bypass platform to palliate patients with inoperable malignant obstruction of the bile duct and duodenum by using LASs.

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Findings and palliative options were discussed with the patient who provided informed consent for double endoscopic bypass using LASs. EUS-CDS was initially performed (Video 1, available online at www.giejournal.org). The dilated extrahepatic bile duct proximal to the site of obstruction was punctured with a 19-gauge needle, and cholangiography was obtained (Fig. 3). A .025-inch guidewire was advanced into the intrahepatics with subsequent tract dilation with a needle-knife and 4-mm dilating balloon (Hurricane balloon; Boston Scientific, Natick, Mass). The sheath of a 10-mm  10-mm LAS (Axios; Xlumena, Mountain View, Calif) was advanced over the wire followed by deployment of the proximal flange under sonographic guidance and distal flange under endoscopic guidance. The stent lumen was then dilated gradually to 10 mm using a dilating balloon (CRE balloon; Boston Scientific) (Fig. 4), and one 7F  5-cm double-pigtail stent was placed within the LAS. The bilirubin level did not drop as expected, and a repeat procedure the following day revealed impingement of the proximal flange against the opposite wall of the bile duct, which likely occurred after initial biliary decompression. One 10-mm  40-mm biliary selfexpandable metallic stent (SEMS) (Wallflex; Boston Scientific) was placed through the existing LAS with its proximal end below the hilum and distal end in the duodenal bulb with immediate adequate biliary flow through the stent (Fig. 5, Video 1). EUS-guided gastrojejunostomy was then performed as previously described (Video 2, available online at www. giejournal.org).5 Briefly, a 20-mm balloon catheter (CRE balloon, Boston Scientific) was passed over a super stiff .035-inch guidewire that was initially placed in the jejunum and was then inflated with fluid (contrast/water) while positioned in the jejunum. The fluid-filled balloon was localized transgastrically by EUS and was punctured with a 19-gauge FNA needle. Bursting of the balloon indicated correct positioning of the needle tip within the small bowel lumen. A .025-inch guidewire was advanced through the needle with subsequent placement of a 15-mm  10-mm anastomotic stent (Axios; Xlumena) over the wire (Fig. 6, Video 2). The patient was discharged home the following day without any adverse events after she was able to tolerate a liquid diet. Jaundice resolved, and her diet was advanced. She continues to tolerate a low-fiber diet 4 months after the procedure.

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ENDOSCOPIC DOUBLE-BYPASS PROCEDURE A 70-year-old woman presented with jaundice, vomiting, and weight loss and was found to have an unresectable head-of-pancreas mass with distal biliary obstruction and GOO (Fig. 1). During endoscopy the ampulla could not be reached because of GOO (Fig. 2); thus, ERCP was not possible. EUS-confirmed pancreatic-head mass and FNA findings were consistent with ductal adenocarcinoma.

Double endoscopic bypass by using lumen-apposing stents

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Figure 2. Luminal obstruction noted in the proximal duodenum rendering ERCP not possible.

Patients with periampullary cancers are frequently diagnosed at an advanced stage in which curative resection is not possible. The median survival rate of these patients is usually between 6 and 12 months, with shorter survival times in the setting of both biliary and duodenal obstruction.13 Thus, symptom palliation of obstructive jaundice and GOO is the focus of therapy. Controversy exists about how to provide the optimal palliative treatment for such patients, and both surgical and endoscopic palliative techniques can be used. Surgical palliation is achieved by biliary and gastric diversion through the creation of choledochojejunal and gastrojejunal anastomoses, respectively. However, these procedures carry significant morbidity. Current common practice is to endoscopically place SEMSs to palliate biliary and duodenal obstruction. Although this practice is associated with high technical success, recurrent GOO occurs commonly because of tumor ingrowth.7 This also renders access to the biliary tree for reintervention difficult and, frequently, not possible.14 We thus propose a total endoscopic bypass platform to palliate such patients with inoperable malignant obstruction of the bile duct and duodenum using LASs. Total endoscopic bypass entails both EUS-GE and EUS-BD, which can be performed during the same sessions and are done under EUS guidance In principle, EUS-GE offers the advantage of surgicalguided gastrojejunostomy in terms of potentially long-

lasting luminal patency without the risk of tumor ingrowth/overgrowth while avoiding the invasiveness and morbidity of surgical procedures. Similarly, EUS-GE offers the advantage of endoscopic stenting in terms of its minimally invasive nature while avoiding short patency rates. EUS-BD has been proposed as a minimally invasive alternative to radiologic and surgical drainage procedures in patients who fail ERCP. EUS-BD is likely as efficacious as percutaneous transhepatic BD and is associated with a decreased rate of reinterventions and with cost savings.15,16 In patients with GOO, EUS-BD can be achieved via EUS-CDS and EUS-HGS depending on the site of the GOO. As compared with ERCP with SEMS placement for distal malignant biliary obstruction, EUS-BD with SEMS placement is equally efficacious and associated with a decreased risk of procedural-related pancreatitis.17 EUSBD also offers drainage away from the site of the GOO (eg, EUS-HGS), which translates into improved biliary access for biliary reinterventions in case of recurrent biliary obstruction. Total endoscopic bypass offers the advantages of each procedure discussed above. Moreover, it can be done within the same endoscopic session and thus avoids the need for repeated procedures and interventions. This potentially can result in cost savings and in resumption of timely palliative chemotherapy when indicated. The advent of LASs has rendered double endoscopic bypass of GOO and biliary obstruction feasible and safe. These stents have a short length, which minimizes the risk of stent obstruction. The wide biflanges and lumenapposing properties minimize the risk of leakage and stent migration.11,12 The use of the smaller 6-mm  8-mm biliary LAS is preferable when available to avoid stent impingement against the opposite wall of the bile duct. This stent is not currently available in the United States.

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Figure 1. Abdominal CT scan showing head of pancreas mass with distal biliary obstruction and proximal dilation.

DISCUSSION

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Double endoscopic bypass by using lumen-apposing stents

Figure 3. A, EUS showing dilated bile duct. B, Bile duct was punctured with a 19-gauge needle, and antegrade cholangiography shows proximal biliary dilation. A guidewire was advanced into the left intrahepatic biliary system.

Figure 4. A, A lumen-apposing stent was placed across the choledochoduodenostomy and was visualized radiographically. B, Stent was dilated with a balloon to 10 mm.

Figure 5. A, Radiographic and B, endoscopic visualization of biliary self-expandable stent that was placed through the preexisting lumen-apposing stent.

In conclusion, double endoscopic bypass using LASs is feasible in patients with unresectable periampullary cancers who present with obstructive jaundice and GOO. This new platform provides these terminally ill patients

with a minimally invasive and efficient palliative approach that is effective, avoids morbidity of alterative procedures, and likely minimizes the need for reinterventions because drainage is established away from the site of obstruction.

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Figure 6. EUS-guided gastrojejunostomy. A, A 20-mm balloon catheter was advanced through site of duodenal obstruction into the jejunum and was filled with contrast. This balloon was targeted transgastrically with a 19-gauge needle using EUS. A wire was then advanced through the needle and the gastrojejunostomy was gradually dilated to 6 mm. B, The sheath of a 15-mm  10-mm lumen-apposing stent was advanced over the wire to the jejunum. C, The stent was deployed. D, The stent lumen was dilated with a 15-mm balloon. E, The jejunum can be seen from within the stent.

DISCLOSURE The following authors disclosed financial relationships relevant to this publication: M. A. Khashab: Consultant for Boston Scientific, Olympus America, and Xlumena and research support recipient from Cook Medical; A. N. Kalloo: Founding member, equity holder, and consultant for Apollo Endosurgery. All other authors disclosed no financial relationships relevant to this publication. Mouen A. Khashab, MD Mohamad El Zein, MD Saowanee Ngamruengphong, MD Yamile Haito Chavez, MD Vivek Kumbhari, MD Amr Ismail, MD Alan H. Tieu, MD Gerad Aguila, RN Vikesh K. Singh, MD, MSc Anne Marie Lennon, MD, PhD Marcia Irene Canto, MD, MHS Anthony N. Kalloo, MD Division of Gastroenterology and Hepatology Department of Medicine The Johns Hopkins Medical Institutions Baltimore, Maryland, USA Abbreviations: CDS, choledochoduodenostomy; EUS-BD, EUS-guided biliary drainage; EUS-CD, choledochoduodenostomy; EUS-GE,

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EUS-guided gastroenterostomy; EUS-HGS, hepatogastrostomy; GOO, gastric outlet obstruction; HGS, hepatogastrostomy; LAS, lumenapposing stents; SEMS, self-expandable metallic stent.

REFERENCES 1. Khashab MA, Varadarajulu S. Endoscopic ultrasonography as a therapeutic modality. Curr Opin Gastroenterol 2012;28:467-76. 2. Khashab MA, Dewitt J. EUS-guided biliary drainage: is it ready for prime time? Yes! Gastrointest Endosc 2013;78:102-5. 3. Khashab MA, Fujii LL, Baron TH, et al. EUS-guided biliary drainage for patients with malignant biliary obstruction with an indwelling duodenal stent (with videos). Gastrointest Endosc 2012;76:209-13. 4. Khashab MA, Kim KJ, Tryggestad EJ, et al. Comparative analysis of traditional and coiled fiducials implanted during EUS for pancreatic cancer patients receiving stereotactic body radiation therapy. Gastrointest Endosc 2012;76:962-71. 5. Khashab MA, Baron TH, Binmoeller KF, et al. EUS-guided gastroenterostomy: a new promising technique in evolution. Gastrointest Endosc 2015;81:1234-6. 6. Lillemoe KD, Cameron JL, Hardacre JM, et al. Is prophylactic gastrojejunostomy indicated for unresectable periampullary cancer? A prospective randomized trial. Ann Surg 1999;230:322-8; discussion 8-30. 7. Khashab M, Alawad AS, Shin EJ, et al. Enteral stenting versus gastrojejunostomy for palliation of malignant gastric outlet obstruction. Surg Endosc 2013;27:2068-75. 8. Khashab MA, Valeshabad AK, Modayil R, et al. EUS-guided biliary drainage by using a standardized approach for malignant biliary obstruction: rendezvous versus direct transluminal techniques (with videos). Gastrointest Endosc 2013;78:734-41. 9. Shah JN, Marson F, Weilert F, et al. Single-operator, single-session EUSguided anterograde cholangiopancreatography in failed ERCP or inaccessible papilla. Gastrointest Endosc 2012;75:56-64. 10. Itoi T, Itokawa F, Uraoka T, et al. Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and

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lumen-apposing metal stent (with videos). Gastrointest Endosc 2013;78:934-9. Binmoeller KF, Shah J. A novel lumen-apposing stent for transluminal drainage of nonadherent extraintestinal fluid collections. Endoscopy 2011;43:337-42. Binmoeller KF, Shah JN. Endoscopic ultrasound-guided gastroenterostomy using novel tools designed for transluminal therapy: a porcine study. Endoscopy 2012;44:499-503. Mutignani M, Tringali A, Shah SG, et al. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy 2007;39:440-7. Khashab MA, Valeshabad AK, Leung W, et al. Multicenter experience with performance of ERCP in patients with an indwelling duodenal stent. Endoscopy 2014;46:252-5.

15. Khashab MA, Valeshabad AK, Afghani E, et al. A comparative evaluation of EUS-guided biliary drainage and percutaneous drainage in patients with distal malignant biliary obstruction and failed ERCP. Dig Dis Sci 2015;60:557-65. 16. Artifon EL, Aparicio D, Paione JB, et al. Biliary drainage in patients with unresectable, malignant obstruction where ERCP fails: endoscopic ultrasonography-guided choledochoduodenostomy versus percutaneous drainage. J Clin Gastroenterol 2012;46:768-74. 17. Dhir V, Itoi T, Khashab MA, et al. Multicenter comparative evaluation of endoscopic placement of expandable metal stents for malignant distal common bile duct obstruction by ERCP or EUS-guided approach. Gastrointest Endosc 2015;81: 913-23.

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