J Hepatobiliary Pancreat Sci (2015) 22:3–11 DOI: 10.1002/jhbp.148
TOPIC
Current status and perspective of endoscopic ultrasonography-guided gastrojejunostomy: endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy (with videos) Takao Itoi · Kentaro Ishii · Reina Tanaka · Junko Umeda · Ryosuke Tonozuka
Published online: 24 August 2014 © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery
Abstract Surgical intervention and, more recently, endoscopic intervention have been performed for the treatment of malignant gastric outlet obstruction. Recently, endoscopic ultrasonography (EUS)-guided gastrojejunostomy using special devices has been established. In line with this, we have developed a novel EUS-guided double-balloonoccluded gastrojejunostomy (EBOG) using a lumenapposing biflanged metal stent. Herein, we describe the technique and outcome of EBOG. Keywords Biflanged metal stent · Double-balloon tube · Endoscopic ultrasonography · Endoscopic ultrasonography-guided gastrojejunostomy
Introduction Malignant gastric outlet obstruction (GOO) is often caused by distal gastric cancer, pancreatic cancer, periampullary cancer, and duodenal cancer [1, 2]. GOO causes nausea, vomiting, and poor oral food intake, resulting in a low quality of terminal life. More often chemotherapy must be discontinued owing to poor general condition. To date, surgical intervention and, more recently, endoscopic intervention has been performed for the treatment of malignant GOO. Recently, endoscopic ultrasonography (EUS)-guided gastrojejunostomy using special devices has been developed. Herein, we describe the current status and perspective of EUS-guided gastrojejunostomy.
T. Itoi (*) · K. Ishii · R. Tanaka · J. Umeda · R. Tonozuka Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan e-mail: [email protected]
Treatment of malignant gastric outlet obstruction Surgical gastrojejunostomy Open surgical gastrojejunostomy has been a standard palliative therapy for malignant GOO; the procedure is associated with good functional outcome and relieves symptoms in almost all patients [3]. Recently, laparoscopic gastrojejunostomy has been commonly used as a minimally invasive surgical therapy. Nonetheless, surgical intervention still results in high morbidity and mortality, regardless of using either open gastrojejunostomy or laparoscopic gastrojejunostomy [3–7].
Endoscopic gastrojejunostomy In recent years, endoscopic metal stent placement for the treatment of malignant GOO has become one of the alternatives to surgical gastrojejunostomy because of its less invasiveness [8–12]. A systematic review of metal stent placement compared with surgical gastrojejunostomy by Jeurnink et al. [3] indicates no significant differences in the technical success rates (96% vs. 100%), early and late major complication rates (7% vs. 6% and 18% vs. 17%, respectively), and persisting symptoms (8% vs. 9%) between stent placement and surgical gastrojejunostomy. The initial clinical success rate was higher after stent placement (89% vs. 72%) and the minor complication rates were less frequently observed after stent placement in the patient series (9% vs. 33%, OR: 0.75, P = 0.8). On the other hand, hospital stay was longer after surgical gastrojejunostomy than after stent placement (13 days vs. 7 days), and recurrent obstructive symptoms were more common after stent placement (18% vs. 1%). These findings suggest that stent placement may be associated with more favorable results in patients
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with a relatively short life expectancy, whereas surgical gastrojejunostomy is preferable in patients with more prolonged prognosis [3]. Since there are several merits and demerits of both surgical gastrojejunostomy and endoscopic metal stent placement, endoscopic gastrojejunostomy appears to be ideal for malignant GOO as a hybrid therapy that includes both advantages of a short length of anastomosis in surgical gastrojejunostomy and less invasiveness in endoscopic metal stent placement. Endoscopic gastrojejunostomy is divided into two approaches, namely, gastrojejunostomy using flexible forward-view endoscopy and using an echoendoscope. In 1991, Swain and Mills reported on gastrojejunostomy performed using flexible forward-view endoscopy using a special compression button [13]. Since then, several investigators reported on gastrojejunostomy using flexible forward-view endoscopy in mainly animal studies and a few clinical studies using flared-type metal stents, magnets or natural orifice transluminal endoscopic surgery [14–20]. In 2002, Fritscher-Ravens et al. reported on EUS-guided gastrojejunostomy in pigs using a special compression button [21, 22]. In 2012, Binmoeller and Shah [23] introduced the lumen-apposing metal stent, which can be attached between the gastric and jejunal walls as an ideal device for EUS-guided gastrojejunostomy in a pig model. Theoretically, direct access under EUS guidance is suitable for gastrojejunostomy. However, an ordinary jejunum often has air and scope insertion can cause air insufflation not only in the stomach but also in the small intestine and colon. Since air precludes ultrasound imaging, safe puncture is not guaranteed. Furthermore, since the original jejunum does not distend, safe puncture is also not possible. To overcome this issue, several workers used the water-filling technique [21–23]. However, rapid infusion of a large amount of water to sufficiently dilate the small bowel may cause serious complications, including hyponatremia and a general burden on the cardiovascular system. In addition, the injection of a large amount of fluid distends not only the targeted small intestine, but also the colon, leading to mispuncture like gastrocolonostomy. Therefore, we developed a unique and novel technique using a double-balloon enteric tube in combination with a biflanged lumen-apposing metal stent for EUS-guided gastrojejunostomy [24].
EUS-guided double-balloon-occluded gastrojejunostomy Indication Symptomatic malignant GOO is suitable for EUS-guided double-balloon-occluded gastrojejunostomy (EBOG) regardless of the size of stenosis. Since the targeted jejunum in
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Fig. 1 Schema of endoscopic ultrasonography (EUS)-guided doubleballoon-occluded gastrojejunostomy (EBOG)
non-altered anatomy patients comes close to the stomach beyond the ligament of Treitz (Fig. 1), it may be unsuitable in cases that show broad invasion, namely, gastric cancer expanding to the stomach and pancreatic tail cancer expanding to the jejunum around the ligament of Treitz. If the jejunum does not come anywhere close to the stomach as in altered anatomy patients, EBOG should not be performed. In cases in which ascites is present, EBOG is possible unless a large amount of ascites precludes the procedure, for example, poor fixation of the jejunum owing to a floating phenomenon. Ultimately, we should consider whether EBOG should be discontinued after confirming that the water-filled jejunum is close to the stomach. Preparation [23–25] A special double-balloon enteric tube (Tokyo Medical University type; Create Medic, Yokohama, Japan) was used for this procedure. In this type of balloon, the saline can be delivered basically in the drainage lumen of the enteric tube between the two balloons (Fig. 2). Currently, we can use two types of biflanged lumen apposing metal stents. The double-reflected nitinol metal stent (10 mm and 16 mm in diameter, 20 mm in length, SPAXUS stent; Taewoong Company, Seoul, Korea) (Fig. 3a) consists of a full silicon-covered stent. Fully expanded, the anchor flange diameter is 27 mm. The collapsible braided stent was delivered through a 10.5-Fr catheter. On the other hand, the AXIOS stent (15 mm in
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Fig. 2 Double-balloon enteric tube
diameter, 10 mm in length; Xlumena, Mountain View, CA, USA) or the Hot AXIOS stent (the same size but with a cautery tip equipped in the tip of the delivery system; Xlumena) (Fig. 3b) consists of a fully covered metal stent with bilateral anchor flanges. Fully expanded, the anchor flange diameter is twice that of the “saddle” section (24 mm and 15 mm, respectively). The stent anchors are designed to distribute pressure evenly on the luminal wall and securely anchor the stent, preventing migration. The proximal and distal anchor flanges also securely hold the jejunal wall to the gastric wall, preventing detachment in the nonadherent jejunum. The collapsible braided stent is delivered through a 10.8-Fr catheter. The proprietary stent delivery system is luer-locked onto the echoendoscope instrumentation channel inlet port to give the operator full control of stent deployment. The handle is designed to enable controlled release of each anchor flange, independent of others, with a full “stop” after the release of the distal anchor flange to prevent premature deployment of the proximal anchor flange. Both stent anchors are designed to distribute pressure evenly on the luminal wall and securely anchor the stent, preventing migration. The proximal and distal anchor flanges also securely hold the jejunum to the gastric wall, preventing detachment in two non-adherent organs. Technique of EBOG in a pig model [24] (Video S1,S2) All procedures are performed in the supine position. A standard upper GI endoscope is advanced into the third portion of the duodenum (Video S1). A 0.025-inch stiff guidewire (VisiGlide or VisiGlide 2; Olympus Medical Systems, Tokyo, Japan) is maximally advanced (Fig. 4a). Then, the endoscope is removed, leaving the guidewire in place. A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability, and two balloons are placed in the jejunum across from the stomach (Fig. 4b). The double bal-
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loons are filled with saline and contrast medium to hold the small intestine open. Sufficient quantity of saline is introduced into the space between the two balloons. A curved linear array echoendoscope (GF-UCT240 or UCT260; Olympus Medical Systems) is advanced into the stomach. After the depiction of the distended jejunum (Fig. 5a), a 19-gauge fine-needle aspiration (FNA) needle (Medi-Globe GmbH, Rosenheim, Germany) is used to puncture the jejunum under EUS guidance (Figs 4c, 5b). A 0.025-inch guidewire (VisiGlide or VisiGlide 2; Olympus Medical Systems) is inserted through the 19-gauge needle. When a SPAXUS or AXIOS stent is used for EBOG, the 19-gauge needle is removed and the gastrojejunostomy tract is dilated over the wire using a 6-Fr electrocautery needle (CystGastro set; Endo-Flex, Voerde, Germany) and a 6-mm dilating balloon (Hurricane; Boston Scientific, Natick, MA, USA) (Fig. 4d). The delivery catheter, including the SPAXUS stent or AXIOS stent, is advanced over the guidewire into the jejunum. When the Hot AXIOS stent is used, the delivery catheter, including the AXIOS stent, is directly advanced over the guidewire into the jejunum with the applying current. The stent is deployed across the gastrojejunostomy tract under combined EUS, fluoroscopic, and endoscopic guidance. The distal anchor flange is deployed first under EUS guidance (Fig. 5c) and fluoroscopic guidance. Traction is then applied to appose the distal anchor flange against the inner jejunum wall, positioning the jejunum in firm apposition against the gastric wall. The proximal anchor flange is then deployed under fluoroscopic (Fig. 4e) and endoscopic guidance (Fig. 6). Finally, the deployed stent lumen is dilated to 10 mm with a dilating balloon (Hurricane). Cefazolin sodium hydrate (0.5 g) was injected intramuscularly after the procedure. Foods with cefalexin (500 mg/day) were given to all pigs on the third day after the procedure.
Outcome The EBOG experiments were performed using SPAXUS stent (first five cases: 10 mm in diameter, last four cases: 16 mm in diameter) on nine female pigs with bodyweights of 25 to 30 kg, which included a preliminary study [24]. Institutional review board approval was obtained from the local animal ethics committee (No. 12085-0), and the pigs were housed at an animal research facility (Minimally Invasive Treatment Animal Laboratory Center, Keio University, Tokyo, Japan). Intramuscular midazolam (0.2 mg/kg), medetomidine (0.1 mg/kg), and atropine sulfate (0.02 mg/ kg) were used to induce general anesthesia, which was maintained using isoflurane. The special double-balloon tube was successfully placed in all cases. The mean procedure time of tube placement was 15.7 min (range 9 to 35 min)
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Fig. 3 Lumen-apposing metal stent. (a) SPAXUS stent. (b) AXIOS stent
Fig. 4 Fluoroscopic imagings of endoscopic ultrasonography (EUS)-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) A 0.025inch stiff guidewire combined with a catheter is maximally advanced under standard esophagogastroduodenoscopy guidance. (b) A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability. (c) The double balloons are filled with saline and contrast medium to hold the small intestine open. A 19-gauge fine-needle aspiration (FNA) needle is used to puncture the jejunum under EUS guidance. (d) The gastrojejunostomy tract is dilated over the wire using a 6-mm dilating balloon. (e) Biflanged lumen-apposing metal stent is placed between stomach and jejunum
(Table 1). EUS could depict the distended jejunum between the two balloons in all cases. Placement of the SPAXUS was also successful in all cases. The mean procedure time of stent placement was 21.9 min (range 16 to 35 min). Pneumoperitoneum was observed in one misdeployment
case, although there were no other early or late adverse events, such as bleeding or perforation (Table 1). In the first five cases, survival experiments were conducted for one month [24]. All animals showed normal eating behavior without signs of infection for one month
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Fig. 5 Endoscopic ultrasonography (EUS) images of EUS-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) EUS shows distended jejunum. (b) A 19-gauge fine-needle aspiration (FNA) needle is used to puncture the jejunum under EUS guidance. (c) The distal anchor flange is deployed first under EUS guidance
Discussion
Fig. 6 Endoscopic imaging proximal flange in the stomach
after the procedure. Endoscopic imaging at the stomach site showed a patent and stable stent without dislodgement in all the pigs. The covering remained intact and there was no hyperplastic tissue ingrowth or overgrowth (Fig. 7a,b). The stents were endoscopically removed without difficulty using biopsy forceps. The stoma was mature in all cases and after the removal of the stent, and a standard gastroscope was easily intubated through the anastomosis to observe both the afferent and efferent loops (Fig. 7c–e). Necropsy showed complete adhesion between the stomach wall and the jejunum wall (Fig. 8a,b).
Endoscopic ultrasonography, which can provide perpendicularly transluminal imaging, had been expected to play a major role in a minimally invasive treatment for the creation of anastomoses between two hollow organs (such as the stomach and jejunum, stomach and bile duct, stomach and gallbladder, duodenum and bile duct, and duodenum and gallbladder) in both animal and human clinical settings. Although successful EUS-guided gastrojejunostomy has been reported in pigs [21–23], there are several hurdles in accomplishing this procedure in the human clinical setting as follows: (1) difficulty of transgastric puncture into the collapsed jejunum using a 19-gauge FNA needle without any preparation; (2) no standard devices for lumen-apposing of the stomach and jejunum throughout the procedure; and (3) no dedicated tool for the creation of anastomosis of nonadherent lumens. Regarding the difficulty of initial 19-gauge FNA needle puncture into the small bowel, it appears that it is not possible to conduct secure puncture into the collapsed jejunum unless some preparation to distend the small bowel (e.g. water-filled technique) is conducted. However, even if a large amount of water is preoperatively injected into the small bowel, theoretically the small bowel moves within the peritoneal cavity and becomes gradually collapsed owing to the flow of water to the colon by peristalsis. Thus, continuous sufficient distention of the small bowel for secure puncture is thought to be difficult. Thus, several investigators have come up with novel devices or techniques (Table 2). Nevertheless, continuous sufficient distention of the small bowel can ensure not only secure puncture but also successful accomplishment of the entire procedure. Therefore, we developed a new balloon tube which can trap the fluid between the double balloon. It enables maintaining
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Table 1 Outcome of endosonography-guided gastrojejunostomy No. case*
1 2 3 4 5 6 7 8 9
Procedure time of placement (min) Enteric tube
Metal stent
35 18 15 16 12 12 13 10 9
29 24 35 21 16 20 16 17 19
Technical success
Yes Yes Yes Yes Yes Yes Yes Yes Yes
Time to second intervention (days)
Stent patency (throughout implantation period)
Tissue condition after stent removal
28 28 27 27 28 14 14 0 0
Patent Patent Patent Patent Patent Patent Patent N/A N/A
No acute injury No acute injury No acute injury Erosion at site of DF No acute injury No acute injury No acute injury N/A N/A
Adverse events Early
Late
None None Pneumoperitonium None None None None None None
None None None None None None None N/A N/A
DF distal flange, N/A not applicable * No. 1 to 5 are included in ref. [24]
Fig. 7 Endoscopic imagings one month after endoscopic ultrasonography (EUS)-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) The covering remained intact and there is no hyperplastic tissue overgrowth. (b) The covering remained intact and there is no hyperplastic tissue ingrowth. (c) Endoscopic imaging after removing stent. (d) Standard EGD easily advances through the anastomosis. (e) Endoscopic imaging shows afferent and efferent loop
distention of the small bowel between the double balloon at the initial FNA needle puncture. In addition, this system is very useful since additional fluid can be easily injected for the distention of the small bowel when the small bowel collapses after needle puncture or bougie use. In fact, in our experimental study, all procedures could be performed
smoothly, similar to the EUS-guided pseudocyst drainage and gallbladder drainage procedures that we performed. Lumen-apposing devices such as a tilt-tag or an anchor wire are ideal for secured EUS-guided gastrojejunostomy since they enable bringing together two nonadherent organs, the stomach and jejunum [21–23]. Although we have not
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Fig. 8 Necropsy shows complete adhesion between the stomach wall and the jejunum wall. (a) Stomach side. (b) Serosa side
Table 2 Summary of reports in the literature of gastrojejunostomy using flexible endoscopy Author (year)
Endoscope Additional technique
Devices
Swain and Mills (1991) [13] Kantsevoy et al. (2005) [14] Chopita et al. (2005) [16] Bergström et al. (2006) [15] Van Hooft et al. (2010) [17] Ryou et al. (2011) [18] Song et al. (2011) [19] Yi et al. (2014) [20] Fritscher-Ravens et al. (2002) [21]
FVE
Mini-laparotomy
Compression button Animal
6 (8GJ) 100%
None
FVE
NOTES
Suture + incision
Animal
2
100%
None
FVE
MCA
F-FCMS
Clinical
15
89%
FVE
NOTES
T-tag + incision
Animal
12
100%
FVE
MCA
F-FCMS
Clinical
18
67%
FVE
NOTES
Suture
FVE
NOTES
T-tag + incision
Animal/ 12/1 Cadaver Animal 10
FVE
NOTES
AFF-FCMS
Animal
EUS
Walter-filled intestine T-tag Water-filled balloon Compression button Walter-filled intestine T-tag Water-filled balloon Compression button Walter-filled intestine Anchor wire LA-FCMS EBOG LA-FCMS EBOG LA-FCMS
Fritscher-Ravens et al. (2003) [22]
EUS
Binmoeller and Shah EUS (2012) [23] Itoi et al. (2013) [24] EUS Present study (2015) EUS
Design
No. of cases
Technical Complications success
1 (6.7%) perforation None 3 (25%) migration
100%
None
100%
None
11
91%
None
Animal
15
100%
None
Animal
16
100%
None
Animal
5
100%
None
Animal Animal
5 9*
100% 100%
1 (20%) pneumoperitoneum 1 (11%) pneumoperitoneum
AFF-FCMS anchoring flap equipped flare type fully covered metal stent, EBOG endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy, EUS endoscopic ultrasonography, F-FCMS flared type fully covered metal stent, FVE forward-view upper GI endoscope, GJ gastrojejunostomy, LA-FCMS lumen-apposing fully covered metal stent, MCA magnetic compression anastomosis, NOTES natural orifice translumenal endoscopic surgery * Including five cases in ref. [24]
used such devices, the use of lumen-apposing devices, such as the SPAXUS or AXIOS stent in combination with our new special double balloon appears to be suitable for safe and reliable EUS-guided gastrojejunostomy. The question is which would be better for EUS-guided gastrojejunostomy. Previously, when using both, the strength of the AXIOS stent flange as an anchor was much higher than that of the SPAXUS stent. Thus, when the delivery system is easily drawn back for proximal flange deployment, the distal
flange of the AXIOS stent works well as an anchor. Thus, the AXIOS stent appears to be suitable and reliable in EBOG procedures. There are several concerns regarding the application of this procedure for clinical use. Some major issues include whether the enteric balloon would go through a gastric outlet obstruction because this procedure is usually performed in patients with such obstruction, and how to avoid “the looping” in the fornix of the stomach. One solution is
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the pushability of this balloon tube. We then use a 0.89-inch hard wire in combination with a 0.025-inch VisiGlide. Thus, even if patients have a resistant gastric outlet obstruction, the balloon tube could go through the obstruction, after the dilation using a large dilating balloon, and reach the jejunum. Another concern is the diameter of the metal stents. The SPAXUS and AXIOS stents are approximately 15 mm in diameter, set by the limitation of the delivery system. A larger size of anastomosis (more than 20 mm in diameter) would appear to be ideal for solid food, although the optimal anastomosis size is unknown even to surgeons. Nevertheless, the current procedure is cumbersome and time-consuming because of the necessity of several steps, namely, needle puncture, guidewire placement, tract dilation, and stent placement. Recently, the Hot AXIOS stent has been developed for one-step deployment without any tract dilation. Furthermore, direct puncture only by the cautery tip-equipped delivery system without a guidewire appears to be possible [26]. It allows actual one-step EBOG that is safe, reliable, and time-saving. Thus far, we have never encountered serious procedure-related adverse events except for a case of pneumoperitoneum [24]. However, we should consider that serious adverse events, such as perforation, bleeding, or stent migration, can occur and may require emergency operation. The limitations of the investigation of EBOG include the small number of experimental studies with pigs and the lack of long-term follow-up to determine the optimal method of maintaining permanent patency. In conclusion, we clarified the feasibility of a novel EUSguided gastrojejunostomy technique using a unique doubleballoon tube and a novel lumen-apposing biflanged metal stent in a pig model. As a next step, clinical prospective trials are warranted. Acknowledgments We are grateful to Ms Maya Vardaman and Associate Professor Edward Barroga, Senior Medical Editor of the Department of International Medical Communications for editing and reviewing the manuscript.
Conflict of interest
None declared.
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4. Lesurtel M, Dehni N, Tiret E, Parc R, Paye F. Palliative surgery for unresectable pancreatic and periampullary cancer: a reappraisal. J Gastrointest Surg. 2006;10:286–91. 5. Nuzzo G, Clemente G, Cadeddu F, Giovannini I. Palliation of unresectable periampullary neoplasms: “surgical” versus “non-surgical” approach. Hepatogastroenterology. 2004;51: 1282–5. 6. Ly J, O’Grady G, Mittal A, Plank L, Windsor JA. A systematic review of methods to palliate malignant gastric outlet obstruction. Surg Endosc. 2010;24:290–7. 7. Ausania F, Vallance AE, Manas DM, Prentis JM, Snowden CP, White SA, et al. Double bypass for inoperable pancreatic malignancy at laparotomy: postoperative complications and long-term outcome. Ann R Coll Surg Engl. 2012;94:563–8. 8. Adler DG, Baron TH. Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol. 2002;97:72–8. 9. Bessoud B, de Baere T, Denys A, Kuoch V, Ducreux M, Precetti S, et al. Malignant gastroduodenal obstruction: palliation with self-expanding metallic stents. J Vasc Interv Radiol. 2005;16:247– 53. 10. Razzaq R, Laasch HU, England R, Marriott A, Martin D. Expandable metal stents for the palliation of malignant gastroduodenal obstruction. Cardiovasc Intervent Radiol. 2001;24:313–8. 11. Maetani I, Tada T, Ukita T, Inoue H, Sakai Y, Nagao J. Comparison of duodenal stent placement with surgical gastrojejunostomy for palliation in patients with duodenal obstructions caused by pancreaticobiliary malignancies. Endoscopy. 2004;36:73–8. 12. Baron TH. Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract. N Engl J Med. 2001;344: 1681–7. 13. Swain CP, Mills TN. Anastomosis at flexible endoscopy: an experimental study of compression button gastrojejunostomy. Gastrointest Endosc. 1991;37:626–31. 14. Kantsevoy SV, Jagannath SB, Niiyama H, Chung SS, Cotton PB, Gostout CJ, et al. Endoscopic gastrojejunostomy with survival in a porcine model. Gastrointest Endosc. 2005;62:287–92. 15. Bergström M, Ikeda K, Swain P, Park PO. Transgastric anastomosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc. 2006;63:307–12. 16. Chopita N, Vaillaverde A, Cope C, Bemedo A, Martinez H, Landoni N, et al. Endoscopic gastroenteric anastomosis using magnets. Endoscopy. 2005;37:313–7. 17. Van Hooft JE, Vleggaar FP, Le Moine O, Bizzotto A, Voermans RP, Costamagna G, et al. Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study. Gastrointest Endsoc. 2010;72: 530–5. 18. Ryou M, Cantillon-Murphy P, Azagury S, Shaikh SN, Ha G, Greenwait I, et al. Smart Self-Assembling Magnet for ENdoscopy (SAMSEN) for transoral endoscopic creation of immediate gastrojejunostomy (with video). Gastrointest Endosc. 2011;73: 353–9. 19. Song TJ, Seo DW, Kim SH, Park do H, Lee SS, Lee SK, et al. Endoscopic gastrojejunostomy with a natural orifice transluminal endoscopic surgery technique. World J Gastroenterol. 2013;19: 3447–52. 20. Yi SW, Chung MJ, Jo JH, Lee KJ, Park JY, Bang S, et al. Gastrojejunostomy by pure natural orifice transluminal endoscopic surgery using a newly designed anastomosing metal stent in a porcine model. Surg Endosc. 2014;28:1439–46. 21. Fritscher-Ravens A, Mosse CA, Mills TN, Mukherjee D, Park PO, Swain P. A through-the-scope device for suturing and tissue approximation under EUS control. Gastrointest Endosc. 2002; 56:737–42.
J Hepatobiliary Pancreat Sci (2015) 22:3–11 22. Fritscher-Ravens A, Mosse CA, Mukherjee D. Transluminal endosurgery: single lumen access anastomotic device for flexible endoscopy. Gastrointest Endosc. 2003;58:585–91. 23. Binmoeller KB, Shah J. Endoscopic ultrasound-guided gastroenterostomy using novel tools designed for transluminal therapy: a porcine study. Endoscopy. 2012;44:499–503. 24. Itoi T, Itokawa F, Uraoka T, Gotoda T, Horii J, Goto O, et al. Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos). Gastrointest Endosc. 2013;78:934–9. 25. Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, et al. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with video). Gastrointest Endosc. 2012;75:870–6. 26. Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014; doi: 10.1016/j.gie.2014.03.038.
Supporting information Additional Supporting Information may be found in the online version of this article at the publisher’s web-site: Video S1 A standard upper GI endoscope is advanced into the third portion of the duodenum. A 0.025-inch stiff guidewire is maximally advanced. Then, the endoscope is
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removed, leaving the guidewire in place. A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability, and two balloons are placed in the jejunum across from the stomach. The double balloons are filled with saline and contrast medium to hold the small intestine open. Video S2 Sufficient quantity of saline is introduced into the space between the two balloons. A curved linear array echoendoscope is advanced into the stomach. A 19-gauge fine-needle aspiration needle is used to puncture the jejunum under EUS guidance. A 0.025-inch guidewire is inserted through the 19-gauge needle. After the gastrojejunostomy tract is dilated over the wire using a 6-Fr electrocautery needle and a 6-mm dilating balloon, the delivery catheter is advanced over the guidewire into the jejunum. The stent is deployed across the gastrojejunostomy tract under combined EUS, fluoroscopic, and endoscopic guidance. The distal anchor flange is deployed first under EUS guidance and fluoroscopic guidance. Traction is then applied to appose the distal anchor flange against the inner jejunum wall, positioning the jejunum in firm apposition against the gastric wall. The proximal anchor flange is then deployed under fluoroscopic and endoscopic guidance.
TOPIC
Current status and perspective of endoscopic ultrasonography-guided gastrojejunostomy: endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy (with videos) Takao Itoi · Kentaro Ishii · Reina Tanaka · Junko Umeda · Ryosuke Tonozuka
Published online: 24 August 2014 © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery
Abstract Surgical intervention and, more recently, endoscopic intervention have been performed for the treatment of malignant gastric outlet obstruction. Recently, endoscopic ultrasonography (EUS)-guided gastrojejunostomy using special devices has been established. In line with this, we have developed a novel EUS-guided double-balloonoccluded gastrojejunostomy (EBOG) using a lumenapposing biflanged metal stent. Herein, we describe the technique and outcome of EBOG. Keywords Biflanged metal stent · Double-balloon tube · Endoscopic ultrasonography · Endoscopic ultrasonography-guided gastrojejunostomy
Introduction Malignant gastric outlet obstruction (GOO) is often caused by distal gastric cancer, pancreatic cancer, periampullary cancer, and duodenal cancer [1, 2]. GOO causes nausea, vomiting, and poor oral food intake, resulting in a low quality of terminal life. More often chemotherapy must be discontinued owing to poor general condition. To date, surgical intervention and, more recently, endoscopic intervention has been performed for the treatment of malignant GOO. Recently, endoscopic ultrasonography (EUS)-guided gastrojejunostomy using special devices has been developed. Herein, we describe the current status and perspective of EUS-guided gastrojejunostomy.
T. Itoi (*) · K. Ishii · R. Tanaka · J. Umeda · R. Tonozuka Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan e-mail: [email protected]
Treatment of malignant gastric outlet obstruction Surgical gastrojejunostomy Open surgical gastrojejunostomy has been a standard palliative therapy for malignant GOO; the procedure is associated with good functional outcome and relieves symptoms in almost all patients [3]. Recently, laparoscopic gastrojejunostomy has been commonly used as a minimally invasive surgical therapy. Nonetheless, surgical intervention still results in high morbidity and mortality, regardless of using either open gastrojejunostomy or laparoscopic gastrojejunostomy [3–7].
Endoscopic gastrojejunostomy In recent years, endoscopic metal stent placement for the treatment of malignant GOO has become one of the alternatives to surgical gastrojejunostomy because of its less invasiveness [8–12]. A systematic review of metal stent placement compared with surgical gastrojejunostomy by Jeurnink et al. [3] indicates no significant differences in the technical success rates (96% vs. 100%), early and late major complication rates (7% vs. 6% and 18% vs. 17%, respectively), and persisting symptoms (8% vs. 9%) between stent placement and surgical gastrojejunostomy. The initial clinical success rate was higher after stent placement (89% vs. 72%) and the minor complication rates were less frequently observed after stent placement in the patient series (9% vs. 33%, OR: 0.75, P = 0.8). On the other hand, hospital stay was longer after surgical gastrojejunostomy than after stent placement (13 days vs. 7 days), and recurrent obstructive symptoms were more common after stent placement (18% vs. 1%). These findings suggest that stent placement may be associated with more favorable results in patients
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with a relatively short life expectancy, whereas surgical gastrojejunostomy is preferable in patients with more prolonged prognosis [3]. Since there are several merits and demerits of both surgical gastrojejunostomy and endoscopic metal stent placement, endoscopic gastrojejunostomy appears to be ideal for malignant GOO as a hybrid therapy that includes both advantages of a short length of anastomosis in surgical gastrojejunostomy and less invasiveness in endoscopic metal stent placement. Endoscopic gastrojejunostomy is divided into two approaches, namely, gastrojejunostomy using flexible forward-view endoscopy and using an echoendoscope. In 1991, Swain and Mills reported on gastrojejunostomy performed using flexible forward-view endoscopy using a special compression button [13]. Since then, several investigators reported on gastrojejunostomy using flexible forward-view endoscopy in mainly animal studies and a few clinical studies using flared-type metal stents, magnets or natural orifice transluminal endoscopic surgery [14–20]. In 2002, Fritscher-Ravens et al. reported on EUS-guided gastrojejunostomy in pigs using a special compression button [21, 22]. In 2012, Binmoeller and Shah [23] introduced the lumen-apposing metal stent, which can be attached between the gastric and jejunal walls as an ideal device for EUS-guided gastrojejunostomy in a pig model. Theoretically, direct access under EUS guidance is suitable for gastrojejunostomy. However, an ordinary jejunum often has air and scope insertion can cause air insufflation not only in the stomach but also in the small intestine and colon. Since air precludes ultrasound imaging, safe puncture is not guaranteed. Furthermore, since the original jejunum does not distend, safe puncture is also not possible. To overcome this issue, several workers used the water-filling technique [21–23]. However, rapid infusion of a large amount of water to sufficiently dilate the small bowel may cause serious complications, including hyponatremia and a general burden on the cardiovascular system. In addition, the injection of a large amount of fluid distends not only the targeted small intestine, but also the colon, leading to mispuncture like gastrocolonostomy. Therefore, we developed a unique and novel technique using a double-balloon enteric tube in combination with a biflanged lumen-apposing metal stent for EUS-guided gastrojejunostomy [24].
EUS-guided double-balloon-occluded gastrojejunostomy Indication Symptomatic malignant GOO is suitable for EUS-guided double-balloon-occluded gastrojejunostomy (EBOG) regardless of the size of stenosis. Since the targeted jejunum in
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Fig. 1 Schema of endoscopic ultrasonography (EUS)-guided doubleballoon-occluded gastrojejunostomy (EBOG)
non-altered anatomy patients comes close to the stomach beyond the ligament of Treitz (Fig. 1), it may be unsuitable in cases that show broad invasion, namely, gastric cancer expanding to the stomach and pancreatic tail cancer expanding to the jejunum around the ligament of Treitz. If the jejunum does not come anywhere close to the stomach as in altered anatomy patients, EBOG should not be performed. In cases in which ascites is present, EBOG is possible unless a large amount of ascites precludes the procedure, for example, poor fixation of the jejunum owing to a floating phenomenon. Ultimately, we should consider whether EBOG should be discontinued after confirming that the water-filled jejunum is close to the stomach. Preparation [23–25] A special double-balloon enteric tube (Tokyo Medical University type; Create Medic, Yokohama, Japan) was used for this procedure. In this type of balloon, the saline can be delivered basically in the drainage lumen of the enteric tube between the two balloons (Fig. 2). Currently, we can use two types of biflanged lumen apposing metal stents. The double-reflected nitinol metal stent (10 mm and 16 mm in diameter, 20 mm in length, SPAXUS stent; Taewoong Company, Seoul, Korea) (Fig. 3a) consists of a full silicon-covered stent. Fully expanded, the anchor flange diameter is 27 mm. The collapsible braided stent was delivered through a 10.5-Fr catheter. On the other hand, the AXIOS stent (15 mm in
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Fig. 2 Double-balloon enteric tube
diameter, 10 mm in length; Xlumena, Mountain View, CA, USA) or the Hot AXIOS stent (the same size but with a cautery tip equipped in the tip of the delivery system; Xlumena) (Fig. 3b) consists of a fully covered metal stent with bilateral anchor flanges. Fully expanded, the anchor flange diameter is twice that of the “saddle” section (24 mm and 15 mm, respectively). The stent anchors are designed to distribute pressure evenly on the luminal wall and securely anchor the stent, preventing migration. The proximal and distal anchor flanges also securely hold the jejunal wall to the gastric wall, preventing detachment in the nonadherent jejunum. The collapsible braided stent is delivered through a 10.8-Fr catheter. The proprietary stent delivery system is luer-locked onto the echoendoscope instrumentation channel inlet port to give the operator full control of stent deployment. The handle is designed to enable controlled release of each anchor flange, independent of others, with a full “stop” after the release of the distal anchor flange to prevent premature deployment of the proximal anchor flange. Both stent anchors are designed to distribute pressure evenly on the luminal wall and securely anchor the stent, preventing migration. The proximal and distal anchor flanges also securely hold the jejunum to the gastric wall, preventing detachment in two non-adherent organs. Technique of EBOG in a pig model [24] (Video S1,S2) All procedures are performed in the supine position. A standard upper GI endoscope is advanced into the third portion of the duodenum (Video S1). A 0.025-inch stiff guidewire (VisiGlide or VisiGlide 2; Olympus Medical Systems, Tokyo, Japan) is maximally advanced (Fig. 4a). Then, the endoscope is removed, leaving the guidewire in place. A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability, and two balloons are placed in the jejunum across from the stomach (Fig. 4b). The double bal-
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loons are filled with saline and contrast medium to hold the small intestine open. Sufficient quantity of saline is introduced into the space between the two balloons. A curved linear array echoendoscope (GF-UCT240 or UCT260; Olympus Medical Systems) is advanced into the stomach. After the depiction of the distended jejunum (Fig. 5a), a 19-gauge fine-needle aspiration (FNA) needle (Medi-Globe GmbH, Rosenheim, Germany) is used to puncture the jejunum under EUS guidance (Figs 4c, 5b). A 0.025-inch guidewire (VisiGlide or VisiGlide 2; Olympus Medical Systems) is inserted through the 19-gauge needle. When a SPAXUS or AXIOS stent is used for EBOG, the 19-gauge needle is removed and the gastrojejunostomy tract is dilated over the wire using a 6-Fr electrocautery needle (CystGastro set; Endo-Flex, Voerde, Germany) and a 6-mm dilating balloon (Hurricane; Boston Scientific, Natick, MA, USA) (Fig. 4d). The delivery catheter, including the SPAXUS stent or AXIOS stent, is advanced over the guidewire into the jejunum. When the Hot AXIOS stent is used, the delivery catheter, including the AXIOS stent, is directly advanced over the guidewire into the jejunum with the applying current. The stent is deployed across the gastrojejunostomy tract under combined EUS, fluoroscopic, and endoscopic guidance. The distal anchor flange is deployed first under EUS guidance (Fig. 5c) and fluoroscopic guidance. Traction is then applied to appose the distal anchor flange against the inner jejunum wall, positioning the jejunum in firm apposition against the gastric wall. The proximal anchor flange is then deployed under fluoroscopic (Fig. 4e) and endoscopic guidance (Fig. 6). Finally, the deployed stent lumen is dilated to 10 mm with a dilating balloon (Hurricane). Cefazolin sodium hydrate (0.5 g) was injected intramuscularly after the procedure. Foods with cefalexin (500 mg/day) were given to all pigs on the third day after the procedure.
Outcome The EBOG experiments were performed using SPAXUS stent (first five cases: 10 mm in diameter, last four cases: 16 mm in diameter) on nine female pigs with bodyweights of 25 to 30 kg, which included a preliminary study [24]. Institutional review board approval was obtained from the local animal ethics committee (No. 12085-0), and the pigs were housed at an animal research facility (Minimally Invasive Treatment Animal Laboratory Center, Keio University, Tokyo, Japan). Intramuscular midazolam (0.2 mg/kg), medetomidine (0.1 mg/kg), and atropine sulfate (0.02 mg/ kg) were used to induce general anesthesia, which was maintained using isoflurane. The special double-balloon tube was successfully placed in all cases. The mean procedure time of tube placement was 15.7 min (range 9 to 35 min)
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Fig. 3 Lumen-apposing metal stent. (a) SPAXUS stent. (b) AXIOS stent
Fig. 4 Fluoroscopic imagings of endoscopic ultrasonography (EUS)-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) A 0.025inch stiff guidewire combined with a catheter is maximally advanced under standard esophagogastroduodenoscopy guidance. (b) A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability. (c) The double balloons are filled with saline and contrast medium to hold the small intestine open. A 19-gauge fine-needle aspiration (FNA) needle is used to puncture the jejunum under EUS guidance. (d) The gastrojejunostomy tract is dilated over the wire using a 6-mm dilating balloon. (e) Biflanged lumen-apposing metal stent is placed between stomach and jejunum
(Table 1). EUS could depict the distended jejunum between the two balloons in all cases. Placement of the SPAXUS was also successful in all cases. The mean procedure time of stent placement was 21.9 min (range 16 to 35 min). Pneumoperitoneum was observed in one misdeployment
case, although there were no other early or late adverse events, such as bleeding or perforation (Table 1). In the first five cases, survival experiments were conducted for one month [24]. All animals showed normal eating behavior without signs of infection for one month
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Fig. 5 Endoscopic ultrasonography (EUS) images of EUS-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) EUS shows distended jejunum. (b) A 19-gauge fine-needle aspiration (FNA) needle is used to puncture the jejunum under EUS guidance. (c) The distal anchor flange is deployed first under EUS guidance
Discussion
Fig. 6 Endoscopic imaging proximal flange in the stomach
after the procedure. Endoscopic imaging at the stomach site showed a patent and stable stent without dislodgement in all the pigs. The covering remained intact and there was no hyperplastic tissue ingrowth or overgrowth (Fig. 7a,b). The stents were endoscopically removed without difficulty using biopsy forceps. The stoma was mature in all cases and after the removal of the stent, and a standard gastroscope was easily intubated through the anastomosis to observe both the afferent and efferent loops (Fig. 7c–e). Necropsy showed complete adhesion between the stomach wall and the jejunum wall (Fig. 8a,b).
Endoscopic ultrasonography, which can provide perpendicularly transluminal imaging, had been expected to play a major role in a minimally invasive treatment for the creation of anastomoses between two hollow organs (such as the stomach and jejunum, stomach and bile duct, stomach and gallbladder, duodenum and bile duct, and duodenum and gallbladder) in both animal and human clinical settings. Although successful EUS-guided gastrojejunostomy has been reported in pigs [21–23], there are several hurdles in accomplishing this procedure in the human clinical setting as follows: (1) difficulty of transgastric puncture into the collapsed jejunum using a 19-gauge FNA needle without any preparation; (2) no standard devices for lumen-apposing of the stomach and jejunum throughout the procedure; and (3) no dedicated tool for the creation of anastomosis of nonadherent lumens. Regarding the difficulty of initial 19-gauge FNA needle puncture into the small bowel, it appears that it is not possible to conduct secure puncture into the collapsed jejunum unless some preparation to distend the small bowel (e.g. water-filled technique) is conducted. However, even if a large amount of water is preoperatively injected into the small bowel, theoretically the small bowel moves within the peritoneal cavity and becomes gradually collapsed owing to the flow of water to the colon by peristalsis. Thus, continuous sufficient distention of the small bowel for secure puncture is thought to be difficult. Thus, several investigators have come up with novel devices or techniques (Table 2). Nevertheless, continuous sufficient distention of the small bowel can ensure not only secure puncture but also successful accomplishment of the entire procedure. Therefore, we developed a new balloon tube which can trap the fluid between the double balloon. It enables maintaining
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Table 1 Outcome of endosonography-guided gastrojejunostomy No. case*
1 2 3 4 5 6 7 8 9
Procedure time of placement (min) Enteric tube
Metal stent
35 18 15 16 12 12 13 10 9
29 24 35 21 16 20 16 17 19
Technical success
Yes Yes Yes Yes Yes Yes Yes Yes Yes
Time to second intervention (days)
Stent patency (throughout implantation period)
Tissue condition after stent removal
28 28 27 27 28 14 14 0 0
Patent Patent Patent Patent Patent Patent Patent N/A N/A
No acute injury No acute injury No acute injury Erosion at site of DF No acute injury No acute injury No acute injury N/A N/A
Adverse events Early
Late
None None Pneumoperitonium None None None None None None
None None None None None None None N/A N/A
DF distal flange, N/A not applicable * No. 1 to 5 are included in ref. [24]
Fig. 7 Endoscopic imagings one month after endoscopic ultrasonography (EUS)-guided double-balloon-occluded gastrojejunostomy (EBOG). (a) The covering remained intact and there is no hyperplastic tissue overgrowth. (b) The covering remained intact and there is no hyperplastic tissue ingrowth. (c) Endoscopic imaging after removing stent. (d) Standard EGD easily advances through the anastomosis. (e) Endoscopic imaging shows afferent and efferent loop
distention of the small bowel between the double balloon at the initial FNA needle puncture. In addition, this system is very useful since additional fluid can be easily injected for the distention of the small bowel when the small bowel collapses after needle puncture or bougie use. In fact, in our experimental study, all procedures could be performed
smoothly, similar to the EUS-guided pseudocyst drainage and gallbladder drainage procedures that we performed. Lumen-apposing devices such as a tilt-tag or an anchor wire are ideal for secured EUS-guided gastrojejunostomy since they enable bringing together two nonadherent organs, the stomach and jejunum [21–23]. Although we have not
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Fig. 8 Necropsy shows complete adhesion between the stomach wall and the jejunum wall. (a) Stomach side. (b) Serosa side
Table 2 Summary of reports in the literature of gastrojejunostomy using flexible endoscopy Author (year)
Endoscope Additional technique
Devices
Swain and Mills (1991) [13] Kantsevoy et al. (2005) [14] Chopita et al. (2005) [16] Bergström et al. (2006) [15] Van Hooft et al. (2010) [17] Ryou et al. (2011) [18] Song et al. (2011) [19] Yi et al. (2014) [20] Fritscher-Ravens et al. (2002) [21]
FVE
Mini-laparotomy
Compression button Animal
6 (8GJ) 100%
None
FVE
NOTES
Suture + incision
Animal
2
100%
None
FVE
MCA
F-FCMS
Clinical
15
89%
FVE
NOTES
T-tag + incision
Animal
12
100%
FVE
MCA
F-FCMS
Clinical
18
67%
FVE
NOTES
Suture
FVE
NOTES
T-tag + incision
Animal/ 12/1 Cadaver Animal 10
FVE
NOTES
AFF-FCMS
Animal
EUS
Walter-filled intestine T-tag Water-filled balloon Compression button Walter-filled intestine T-tag Water-filled balloon Compression button Walter-filled intestine Anchor wire LA-FCMS EBOG LA-FCMS EBOG LA-FCMS
Fritscher-Ravens et al. (2003) [22]
EUS
Binmoeller and Shah EUS (2012) [23] Itoi et al. (2013) [24] EUS Present study (2015) EUS
Design
No. of cases
Technical Complications success
1 (6.7%) perforation None 3 (25%) migration
100%
None
100%
None
11
91%
None
Animal
15
100%
None
Animal
16
100%
None
Animal
5
100%
None
Animal Animal
5 9*
100% 100%
1 (20%) pneumoperitoneum 1 (11%) pneumoperitoneum
AFF-FCMS anchoring flap equipped flare type fully covered metal stent, EBOG endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy, EUS endoscopic ultrasonography, F-FCMS flared type fully covered metal stent, FVE forward-view upper GI endoscope, GJ gastrojejunostomy, LA-FCMS lumen-apposing fully covered metal stent, MCA magnetic compression anastomosis, NOTES natural orifice translumenal endoscopic surgery * Including five cases in ref. [24]
used such devices, the use of lumen-apposing devices, such as the SPAXUS or AXIOS stent in combination with our new special double balloon appears to be suitable for safe and reliable EUS-guided gastrojejunostomy. The question is which would be better for EUS-guided gastrojejunostomy. Previously, when using both, the strength of the AXIOS stent flange as an anchor was much higher than that of the SPAXUS stent. Thus, when the delivery system is easily drawn back for proximal flange deployment, the distal
flange of the AXIOS stent works well as an anchor. Thus, the AXIOS stent appears to be suitable and reliable in EBOG procedures. There are several concerns regarding the application of this procedure for clinical use. Some major issues include whether the enteric balloon would go through a gastric outlet obstruction because this procedure is usually performed in patients with such obstruction, and how to avoid “the looping” in the fornix of the stomach. One solution is
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the pushability of this balloon tube. We then use a 0.89-inch hard wire in combination with a 0.025-inch VisiGlide. Thus, even if patients have a resistant gastric outlet obstruction, the balloon tube could go through the obstruction, after the dilation using a large dilating balloon, and reach the jejunum. Another concern is the diameter of the metal stents. The SPAXUS and AXIOS stents are approximately 15 mm in diameter, set by the limitation of the delivery system. A larger size of anastomosis (more than 20 mm in diameter) would appear to be ideal for solid food, although the optimal anastomosis size is unknown even to surgeons. Nevertheless, the current procedure is cumbersome and time-consuming because of the necessity of several steps, namely, needle puncture, guidewire placement, tract dilation, and stent placement. Recently, the Hot AXIOS stent has been developed for one-step deployment without any tract dilation. Furthermore, direct puncture only by the cautery tip-equipped delivery system without a guidewire appears to be possible [26]. It allows actual one-step EBOG that is safe, reliable, and time-saving. Thus far, we have never encountered serious procedure-related adverse events except for a case of pneumoperitoneum [24]. However, we should consider that serious adverse events, such as perforation, bleeding, or stent migration, can occur and may require emergency operation. The limitations of the investigation of EBOG include the small number of experimental studies with pigs and the lack of long-term follow-up to determine the optimal method of maintaining permanent patency. In conclusion, we clarified the feasibility of a novel EUSguided gastrojejunostomy technique using a unique doubleballoon tube and a novel lumen-apposing biflanged metal stent in a pig model. As a next step, clinical prospective trials are warranted. Acknowledgments We are grateful to Ms Maya Vardaman and Associate Professor Edward Barroga, Senior Medical Editor of the Department of International Medical Communications for editing and reviewing the manuscript.
Conflict of interest
None declared.
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Supporting information Additional Supporting Information may be found in the online version of this article at the publisher’s web-site: Video S1 A standard upper GI endoscope is advanced into the third portion of the duodenum. A 0.025-inch stiff guidewire is maximally advanced. Then, the endoscope is
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removed, leaving the guidewire in place. A double-balloon tube is perorally inserted over the guidewire in combination with a 0.89-inch dedicated guidewire for better torquability, and two balloons are placed in the jejunum across from the stomach. The double balloons are filled with saline and contrast medium to hold the small intestine open. Video S2 Sufficient quantity of saline is introduced into the space between the two balloons. A curved linear array echoendoscope is advanced into the stomach. A 19-gauge fine-needle aspiration needle is used to puncture the jejunum under EUS guidance. A 0.025-inch guidewire is inserted through the 19-gauge needle. After the gastrojejunostomy tract is dilated over the wire using a 6-Fr electrocautery needle and a 6-mm dilating balloon, the delivery catheter is advanced over the guidewire into the jejunum. The stent is deployed across the gastrojejunostomy tract under combined EUS, fluoroscopic, and endoscopic guidance. The distal anchor flange is deployed first under EUS guidance and fluoroscopic guidance. Traction is then applied to appose the distal anchor flange against the inner jejunum wall, positioning the jejunum in firm apposition against the gastric wall. The proximal anchor flange is then deployed under fluoroscopic and endoscopic guidance.
