- Email: [email protected]
Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos)
NEW METHODS: Clinical Endoscopy
Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos) Marc Barthet, MD,1,2 Kenneth F. Binmoeller, MD,3 Geoffroy Vanbiervliet, MD, MSc,1,4 Jean-Michel Gonzalez, MD,1,2 Todd H. Baron, MD, FASGE,5 Stéphane Berdah, MD, PhD1,2 Marseille, France
Background: We established feasibility and safety for natural orifice transluminal endoscopic surgery (NOTES) GI anastomosis with a lumen-apposing stent in live pigs. This approach was performed in 3 patients. Objective: Creation of a NOTES gastroduodenal anastomosis in patients. Design: Case series. Setting: Two tertiary-care referral centers at large academic hospitals in France and in the United States. Patients: Patients with refractory benign duodenal stenosis and malignant duodenal obstruction. Intervention: NOTES GI anastomosis with a lumen-apposing stent. Main Outcome Measurements: Disappearence of gastric outlet obstruction. Results: All 3 procedures were technically successful and uneventful, except 1 minor adverse event. There were no instances of stent occlusion or migration during follow-up. All patients resumed a normal diet. Limitations: Small case series. Conclusion: NOTES gastroenteric anastomosis is feasible and safe in humans. A prospective pilot study is warranted.
There have been few attempts to endoscopically create gastrojejunal anastomoses by using hybrid techniques or a pure natural orifice transluminal endoscopic surgery (NOTES) approach by using T-tags or suturing devices.1-3 A novel technique that used EUS-guided placement of a fully covered biflanged self-expandable lumen-apposing stent (LAS) was reported in a porcine model.4 This NOTES procedure that used the LAS was found to be feasible and reproducible without leakage or adverse events in animals.5,6 We report the first case series of a pure NOTES approach to endoscopic gastroenterostomy by using the LAS at 2 academic centers in Marseille, France and San Francisco, California, USA.
PATIENTS AND METHODS
Abbreviations: LSA, lumen-apposing stent; NOTES, natural orifice transluminal endoscopic surgery.
Current affiliations: Faculty of Medicine, Aix-Marseille University (1), Gastroenterology, Public Assistance Hospitals of Marseille, Marseille, France (2), Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA (3), Gastroenterology, University Hospital of Nice, Nice, France (4), Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA (5).
DISCLOSURE: K. Binmoeller is the founder of, chief medical officer for, and an equity holder in Xlumena. All other authors disclosed no financial relationships relevant to this article. Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.09.039
The first case was a 30-year-old man referred to the Marseille center for management of benign gastric outlet obstruction because of duodenal cystic dystrophy and alcoholic chronic pancreatitis (Video 1, available online at www.giejournal.org). Portal vein thrombosis with severe perigastric varices was present. The patient refused surgery. The procedure was performed in the operating suite with the patient under general anesthesia by using both a therapeutic linear echoendoscope (UTK; Pentax, Tokyo, Japan) and a therapeutic, double-channel gastroscope
Reprint requests: Professor Marc Barthet, MD, PhD, Chemin des Bourrely, 13915 Marseille, cedex 20, France.
Received May 28, 2014. Accepted September 10, 2014.
www.giejournal.org
Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 215
NOTES gastroenterostomy with a biflanged lumen-apposing stent
(Pentax EG3890TK; Tokyo, Japan). Carbon dioxide insufflation and fluoroscopic guidance were used. Because of retained gastric contents, the stomach was cleared by using a dual-channel gastroscope (Pentax EG3890TK; Tokyo, Japan), saline solution irrigation with a water pump (Flushing Pump OFP2; Olympus, Tokyo, Japan), and polyp net retrievers (Roth Net Universal retriever; Life Partners Europe, Bagnolet, France) immediately before the anastomosis. To avoid surrounding vessels and to direct the needle toward the ligament of Treitz, a 19-gauge FNA needle (Cook Endoscopy, Winston-Salem, NC) was passed through the gastric wall under EUS guidance (Video 1). A guidewire was passed through the needle into the peritoneal cavity close to the ligament of Treitz. The echoendoscope was removed, leaving the guidewire in place. The double-channel endoscope was introduced over the guidewire and into the stomach. A 6F cautery device (Gflex, Cystotome; Endoflex, Brussels, Belgium) was introduced over the wire and, by using electrocautery, was passed across the gastric wall. A 20-mm balloon dilation was performed. The endoscope was passed into the peritoneal cavity, the guidewire was removed, and the proximal jejunum was grasped with a forceps (Twin Grasper; Ovesco, Tubingen, Germany). A 19-gauge FNA needle (Cook Endoscopy) was introduced through the 3.8-mm channel, and the distal duodenal loop was punctured. Contrast material was injected to confirm entry, followed by insertion of a 0.035inch guidewire. A 15-mm diameter LAS with electrocautery located at the tip of the delivery system (Hot Axios; XLumena, Mountain View, Calif) was advanced over the wire into the duodenal lumen. The distal flange was deployed and the bowel loop gently withdrawn toward the gastric cavity by using both the stent catheter and the grasping forceps. The proximal stent was released into the gastric cavity. Contrast material injection confirmed patency of the anastomosis and the lack of extravasation. CT scan at day 2 showed the good position of the stent without fluid leakage (Fig. 1). Endoscopic control at day 5 showed the proximal flange of the stent visible in the gastric lumen (Fig. 2) and the ability to pass through the stent in the duodenum (Fig. 3). Two additional cases were performed in San Francisco (Video 2, available online at www.giejournal.org). A 34year-old man (patient 2) was admitted with metastatic pancreatic adenocarcinoma. He had previously undergone a palliative hepaticojejunostomy and gastrojejunostomy. Tumor recurrence with complete obstruction of the gastrojejunal anastomosis occurred 3 months later. An attempt to palliate gastric outlet obstruction with enteral stent placement failed. Endoscopic gastrojejunostomy was performed for palliation. After the gastric contents were cleared endoscopically, the stomach wall was irrigated with Betadine solution (MEDA Pharma, Mérignac, France). A 15-mm diameter LAS was deployed by using the same technique described previously. The procedure took 49 minutes and was without any adverse event. 216 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015
Barthet et al
Figure 1. CT scan after Axios stent placement between the posterior gastric wall and the duodenojejunal angle (Axios stent; XLumena, Mountain View, Calif).
Figure 2. Endoscopic view of stent located at the posterior wall of the stomach.
A 71-year-old man (patient 3) with metastatic pancreatic adenocarcinoma was admitted with gastric outlet obstruction. At upper endoscopy, the entire second and third portions of the duodenum were obstructed with friable, necrotic tumor. Endoscopic gastrojejunostomy was attempted. A first attempt at LAS deployment was technically compromised because of an overly generous needle-knife incision of the jejunum. After deployment of the distal flange in the jejunum, the flange pulled out of the opening during retraction of the jejunum into the stomach. A second 15-mm LAS was reinserted immediately through the same orifice over a guidewire, the distal flange being successfully deployed in the jejunal lumen. Then both the endoscope and stent catheter were cautiously pulled back toward the stomach by securing the jejunal loop www.giejournal.org
Barthet et al
NOTES gastroenterostomy with a biflanged lumen-apposing stent
patient was discharged but died on day 19 from progression of the underlying malignancy.
DISCUSSION
All procedures were technically and clinically successful, except for one minor adverse event, which was managed endoscopically. There were no adverse events. The first patient was given nothing by mouth for 2 days after the procedure. Liquids were initiated 4 days after the procedure and advanced to normal diet by day 6, without nausea or vomiting. A plain abdominal radiograph performed before initiation of oral intake showed excellent stent position and no pneumoperitoneum. The patient was discharged on day 8. At 1-month follow-up, he was eating normally and had gained 3 kg. At upper endoscopy, no gastric stasis was noted, and the stent was patent without tissue ingrowth at the edges. We elected to remove the stent at 1 month because of the benign disease. The stent was removed, and anastomotic patency was confirmed by endoscopy and fluoroscopic contrast material injection. A 7F, double-pigtail plastic stent was placed across the anastomosis as a safeguard to maintain gastroduodenal anastomosis. Another endoscopic examination was performed 2 weeks later, and the anastomosis was narrowed. A 20mm balloon dilation was performed and a new LAS was placed. The patient continues to eat normally with weight gain. Stent removal is planned for 3 months after insertion. The postoperative course for the 2 other patients also was uneventful. Patient 2 underwent an upper radiographic contrast study, which confirmed a patent anastomosis without leakage. The patient’s diet was advanced, and he was eating normally at 1 month follow-up. Patient 3 also underwent a contrast study, which revealed a patent, leak-free anastomosis. The diet was advanced, and the
The creation of an endoscopic GI anastomosis has been done mainly in animal studies, the exception being the use of magnets to create a gastroduodenal anastomosis.7 We developed experimental approaches for pure NOTES gastrojejunal anastomosis and tested them in porcine nonsurvival and survival experiments.2,3,6,8-10 We found that suturing devices led to adverse events and leakage. The Marseille team conducted a prospective study in 9 live pigs, with a 3-week survival study by using T-tags.2 The average procedure duration was 143 50.8 minutes. Three animals died as a result of anastomotic leakage confirmed at necropsy and histopathology. In the surviving animals, histology confirmed patent anastomoses with collagen scar tissue and continuity of the mucosa and mucosal muscle layers. These findings were confirmed in a second series.3 In half of the cases, anastomotic leakage occurred, suggesting that creation of endoscopic gastrojejunal anastomoses by using T-tags is not reliable. A novel technique that uses EUS-guided placement of an LAS was reported by the Binmoeller and Shah team.4 An endoluminal anastomosis was created by using a fully covered self-expandable LAS with flange diameters twice that of the short stent “waist.” The main technical difficulty was advancement of devices under EUS guidance in the mobile small bowel. We reported on the creation of a gastrojejunostomy that used the LAS in live pigs.5,6 Procedures were successfully completed in all 6 animals, with a mean ( standard deviation) operative time of 26 6.7 minutes. All animals were alive after 3 weeks. At necropsy the stents were in good position in all cases and without evidence of peritonitis. Histopathology confirmed permeable anastomoses with collagen scar tissue and continuity of the mucosa and mucosal muscle layers. The San Francisco and Marseille teams performed the first 3 human cases from January to April 2014. All of the included patients refused surgery, and consents were obtained after each patient was fully informed of the novel nature of this endoscopic technique. Institutional review board approval was not required. All procedures were technically and clinically successful without adverse events, except 1 minor adverse event, which was managed endoscopically. All patients received antibiotic prophylaxis and underwent intensive gastric cleansing at the onset of the procedure with either saline solution or iodine. No scientific data are available to recommend which of these approaches to use. One patient had a technical adverse event caused by excessive enlargement of the jejunal site with a needleknife, without compromising the outcome. Fortunately,
www.giejournal.org
Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 217
Figure 3. Endoscopic view through the stent showing the small-bowel mucosa.
with a rat-tooth forceps. On post-procedure day 2, an oral barium contrast study revealed a patent, leak-free anastomosis, and the patient’s diet was advanced.
RESULTS
NOTES gastroenterostomy with a biflanged lumen-apposing stent
Barthet et al
bypass and duodenal stenting in patients with malignant gastric outlet obstruction would be worthwhile. We also plan to evaluate endoscopic gastrojejunal anastomosis for the management of obesity. Our team currently is performing an experimental study in pigs to assess the nutritional and metabolic impact of endoscopic gastrojejunal anastomosis. Many questions remain, including the optimal length of the jejunal loop and the need for pyloric closure.
this was endoscopically managed without clinical consequences. We believe that creation of the gastric orifice is best achieved with balloon dilation as shown previously in a randomized experimental study.11 For accessing the duodenal or jejunal lumen, we believe the best approach is to puncture with a 19-gauge FNA needle, allowing contrast material injection and fluoroscopic guidance followed by guidewire insertion. This allows passage of a 6F cystotome followed by stent deployment or by use of a stent-delivery system that has an electrocautery tip. All patients tolerated early initiation of dietary intake and could be advanced to a normal diet at 1 month after the procedure. However, it is not clear that a durable anastomosis without an indwelling stent can be achieved or the optimal time the LAS should remain in place. We plan to assess these questions in subsequent studies. The limitations of this study are the small series of only 3 cases and heterogeneous patient characteristics and etiologies of obstruction (benign and malignant). Our team plans a prospective pilot study of gastroduodenal anastomosis by using EUS guidance to direct the guidewire close to the ligament of Treitz. The remaining procedure after intensive cleaning of the stomach with saline solution irrigation will include (1) balloon dilation for the gastric orifice, (2) a 19-gauge FNA needle for accessing the duodenal lumen and grasping the intestine with a forceps in the other channel of the double-operating-channel endoscope, (3) contrast material injection into the duodenal lumen with fluoroscopic guidance and insertion of a guidewire, (4) insertion of the LAS with an electrocautery tip in the duodenal lumen, (5) deployment of the distal flange, (6) withdrawal of the endoscope toward the gastric lumen, and (7) release of the proximal flange into the gastric lumen. The protocol outlined is pending final ethics committee approval. Indications for NOTES endoscopic GI anastomoses are in evolution. Endoscopic gastroduodenal anastomosis could be an alternative to laparoscopic surgery in cases of benign stenosis of the duodenum and will require randomized trials before it can be recommended in clinical practice. Endoscopic gastroduodenal anastomosis also could be used as an alternative to duodenal stent placement in cases of malignant stenosis. In the future, comparing outcomes of this new technique with surgical
1. Von Renteln D, Vassiliou MC, McKenna D, et al. Endoscopic vs laparoscopic gastrojejunal anastomosis for duodenal obstruction: a randomized study in a porcine model. Endoscopy 2012;44:161-8. 2. Vanbiervliet G, Gonzalez JM, Bonin E, et al. Gastrojejunal anastomosis exclusively using the NOTES technique in live pigs: a feasibility and reliability study. Surg Innov 2013;19:409-18. 3. Gonzalez JM, Bonin E, Vanbiervliet G, et al. Feasibility, efficacy and safety of pure transluminal endoscopic gastrojejunal bypass in an outlet obstruction in survival animal model. Endoscopy International Open 2013;1:e31-8. 4. Binmoeller KF, Shah JN. Endoscopic ultrasound-guided gastroenterostomy using a new tool designed for transluminal therapy: a porcine study. Endoscopy 2012;44:499-503. 5. Vanbiervliet G, Garces-Duran R, Garnier E, et al. NOTES gastroenteric anastomosis using a tissue apposing stent: a reproducible and efficient technique in live pigs. Endoscopy 2014;46:871-7. 6. Barthet M, Vanbiervliet G, Gonzalez JM. Innovation and NOTES. Endoscopy 2014;46:346-9. 7. Van Hooft JE, Vleggaar FP, Lemoine O, et al. Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study. Gastrointest Endosc 2010;72:530-5. 8. Kantsevoy SV, Bitner M, Mitrakov A, et al. Endoscopic suturing closure of large defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc 2014;79:503-7. 9. Bergström M, Ikeda K, Swain P, et al. Transgastric anastomosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc 2006;63:307-12. 10. Chiu PW, Wai Ng EK, Teoh AY, et al. Transgastric endoluminal gastrojejunal anastomosis: technical development from bench to animal study. Gastrointest Endosc 2010;71:390-3. 11. Teoh AY, Chiu PW, Lau JY, et al. Randomized comparative trial of a novel one-step needle sphincterotome versus direct incision and balloon dilation used to create gastrotomies for natural orifice translumenal endoscopic surgery (NOTES) in the porcine model. Surg Endosc 2011;25:3116-21.
218 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015
www.giejournal.org
REFERENCES
Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos) Marc Barthet, MD,1,2 Kenneth F. Binmoeller, MD,3 Geoffroy Vanbiervliet, MD, MSc,1,4 Jean-Michel Gonzalez, MD,1,2 Todd H. Baron, MD, FASGE,5 Stéphane Berdah, MD, PhD1,2 Marseille, France
Background: We established feasibility and safety for natural orifice transluminal endoscopic surgery (NOTES) GI anastomosis with a lumen-apposing stent in live pigs. This approach was performed in 3 patients. Objective: Creation of a NOTES gastroduodenal anastomosis in patients. Design: Case series. Setting: Two tertiary-care referral centers at large academic hospitals in France and in the United States. Patients: Patients with refractory benign duodenal stenosis and malignant duodenal obstruction. Intervention: NOTES GI anastomosis with a lumen-apposing stent. Main Outcome Measurements: Disappearence of gastric outlet obstruction. Results: All 3 procedures were technically successful and uneventful, except 1 minor adverse event. There were no instances of stent occlusion or migration during follow-up. All patients resumed a normal diet. Limitations: Small case series. Conclusion: NOTES gastroenteric anastomosis is feasible and safe in humans. A prospective pilot study is warranted.
There have been few attempts to endoscopically create gastrojejunal anastomoses by using hybrid techniques or a pure natural orifice transluminal endoscopic surgery (NOTES) approach by using T-tags or suturing devices.1-3 A novel technique that used EUS-guided placement of a fully covered biflanged self-expandable lumen-apposing stent (LAS) was reported in a porcine model.4 This NOTES procedure that used the LAS was found to be feasible and reproducible without leakage or adverse events in animals.5,6 We report the first case series of a pure NOTES approach to endoscopic gastroenterostomy by using the LAS at 2 academic centers in Marseille, France and San Francisco, California, USA.
PATIENTS AND METHODS
Abbreviations: LSA, lumen-apposing stent; NOTES, natural orifice transluminal endoscopic surgery.
Current affiliations: Faculty of Medicine, Aix-Marseille University (1), Gastroenterology, Public Assistance Hospitals of Marseille, Marseille, France (2), Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA (3), Gastroenterology, University Hospital of Nice, Nice, France (4), Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA (5).
DISCLOSURE: K. Binmoeller is the founder of, chief medical officer for, and an equity holder in Xlumena. All other authors disclosed no financial relationships relevant to this article. Copyright ª 2015 by the American Society for Gastrointestinal Endoscopy 0016-5107/$36.00 http://dx.doi.org/10.1016/j.gie.2014.09.039
The first case was a 30-year-old man referred to the Marseille center for management of benign gastric outlet obstruction because of duodenal cystic dystrophy and alcoholic chronic pancreatitis (Video 1, available online at www.giejournal.org). Portal vein thrombosis with severe perigastric varices was present. The patient refused surgery. The procedure was performed in the operating suite with the patient under general anesthesia by using both a therapeutic linear echoendoscope (UTK; Pentax, Tokyo, Japan) and a therapeutic, double-channel gastroscope
Reprint requests: Professor Marc Barthet, MD, PhD, Chemin des Bourrely, 13915 Marseille, cedex 20, France.
Received May 28, 2014. Accepted September 10, 2014.
www.giejournal.org
Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 215
NOTES gastroenterostomy with a biflanged lumen-apposing stent
(Pentax EG3890TK; Tokyo, Japan). Carbon dioxide insufflation and fluoroscopic guidance were used. Because of retained gastric contents, the stomach was cleared by using a dual-channel gastroscope (Pentax EG3890TK; Tokyo, Japan), saline solution irrigation with a water pump (Flushing Pump OFP2; Olympus, Tokyo, Japan), and polyp net retrievers (Roth Net Universal retriever; Life Partners Europe, Bagnolet, France) immediately before the anastomosis. To avoid surrounding vessels and to direct the needle toward the ligament of Treitz, a 19-gauge FNA needle (Cook Endoscopy, Winston-Salem, NC) was passed through the gastric wall under EUS guidance (Video 1). A guidewire was passed through the needle into the peritoneal cavity close to the ligament of Treitz. The echoendoscope was removed, leaving the guidewire in place. The double-channel endoscope was introduced over the guidewire and into the stomach. A 6F cautery device (Gflex, Cystotome; Endoflex, Brussels, Belgium) was introduced over the wire and, by using electrocautery, was passed across the gastric wall. A 20-mm balloon dilation was performed. The endoscope was passed into the peritoneal cavity, the guidewire was removed, and the proximal jejunum was grasped with a forceps (Twin Grasper; Ovesco, Tubingen, Germany). A 19-gauge FNA needle (Cook Endoscopy) was introduced through the 3.8-mm channel, and the distal duodenal loop was punctured. Contrast material was injected to confirm entry, followed by insertion of a 0.035inch guidewire. A 15-mm diameter LAS with electrocautery located at the tip of the delivery system (Hot Axios; XLumena, Mountain View, Calif) was advanced over the wire into the duodenal lumen. The distal flange was deployed and the bowel loop gently withdrawn toward the gastric cavity by using both the stent catheter and the grasping forceps. The proximal stent was released into the gastric cavity. Contrast material injection confirmed patency of the anastomosis and the lack of extravasation. CT scan at day 2 showed the good position of the stent without fluid leakage (Fig. 1). Endoscopic control at day 5 showed the proximal flange of the stent visible in the gastric lumen (Fig. 2) and the ability to pass through the stent in the duodenum (Fig. 3). Two additional cases were performed in San Francisco (Video 2, available online at www.giejournal.org). A 34year-old man (patient 2) was admitted with metastatic pancreatic adenocarcinoma. He had previously undergone a palliative hepaticojejunostomy and gastrojejunostomy. Tumor recurrence with complete obstruction of the gastrojejunal anastomosis occurred 3 months later. An attempt to palliate gastric outlet obstruction with enteral stent placement failed. Endoscopic gastrojejunostomy was performed for palliation. After the gastric contents were cleared endoscopically, the stomach wall was irrigated with Betadine solution (MEDA Pharma, Mérignac, France). A 15-mm diameter LAS was deployed by using the same technique described previously. The procedure took 49 minutes and was without any adverse event. 216 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015
Barthet et al
Figure 1. CT scan after Axios stent placement between the posterior gastric wall and the duodenojejunal angle (Axios stent; XLumena, Mountain View, Calif).
Figure 2. Endoscopic view of stent located at the posterior wall of the stomach.
A 71-year-old man (patient 3) with metastatic pancreatic adenocarcinoma was admitted with gastric outlet obstruction. At upper endoscopy, the entire second and third portions of the duodenum were obstructed with friable, necrotic tumor. Endoscopic gastrojejunostomy was attempted. A first attempt at LAS deployment was technically compromised because of an overly generous needle-knife incision of the jejunum. After deployment of the distal flange in the jejunum, the flange pulled out of the opening during retraction of the jejunum into the stomach. A second 15-mm LAS was reinserted immediately through the same orifice over a guidewire, the distal flange being successfully deployed in the jejunal lumen. Then both the endoscope and stent catheter were cautiously pulled back toward the stomach by securing the jejunal loop www.giejournal.org
Barthet et al
NOTES gastroenterostomy with a biflanged lumen-apposing stent
patient was discharged but died on day 19 from progression of the underlying malignancy.
DISCUSSION
All procedures were technically and clinically successful, except for one minor adverse event, which was managed endoscopically. There were no adverse events. The first patient was given nothing by mouth for 2 days after the procedure. Liquids were initiated 4 days after the procedure and advanced to normal diet by day 6, without nausea or vomiting. A plain abdominal radiograph performed before initiation of oral intake showed excellent stent position and no pneumoperitoneum. The patient was discharged on day 8. At 1-month follow-up, he was eating normally and had gained 3 kg. At upper endoscopy, no gastric stasis was noted, and the stent was patent without tissue ingrowth at the edges. We elected to remove the stent at 1 month because of the benign disease. The stent was removed, and anastomotic patency was confirmed by endoscopy and fluoroscopic contrast material injection. A 7F, double-pigtail plastic stent was placed across the anastomosis as a safeguard to maintain gastroduodenal anastomosis. Another endoscopic examination was performed 2 weeks later, and the anastomosis was narrowed. A 20mm balloon dilation was performed and a new LAS was placed. The patient continues to eat normally with weight gain. Stent removal is planned for 3 months after insertion. The postoperative course for the 2 other patients also was uneventful. Patient 2 underwent an upper radiographic contrast study, which confirmed a patent anastomosis without leakage. The patient’s diet was advanced, and he was eating normally at 1 month follow-up. Patient 3 also underwent a contrast study, which revealed a patent, leak-free anastomosis. The diet was advanced, and the
The creation of an endoscopic GI anastomosis has been done mainly in animal studies, the exception being the use of magnets to create a gastroduodenal anastomosis.7 We developed experimental approaches for pure NOTES gastrojejunal anastomosis and tested them in porcine nonsurvival and survival experiments.2,3,6,8-10 We found that suturing devices led to adverse events and leakage. The Marseille team conducted a prospective study in 9 live pigs, with a 3-week survival study by using T-tags.2 The average procedure duration was 143 50.8 minutes. Three animals died as a result of anastomotic leakage confirmed at necropsy and histopathology. In the surviving animals, histology confirmed patent anastomoses with collagen scar tissue and continuity of the mucosa and mucosal muscle layers. These findings were confirmed in a second series.3 In half of the cases, anastomotic leakage occurred, suggesting that creation of endoscopic gastrojejunal anastomoses by using T-tags is not reliable. A novel technique that uses EUS-guided placement of an LAS was reported by the Binmoeller and Shah team.4 An endoluminal anastomosis was created by using a fully covered self-expandable LAS with flange diameters twice that of the short stent “waist.” The main technical difficulty was advancement of devices under EUS guidance in the mobile small bowel. We reported on the creation of a gastrojejunostomy that used the LAS in live pigs.5,6 Procedures were successfully completed in all 6 animals, with a mean ( standard deviation) operative time of 26 6.7 minutes. All animals were alive after 3 weeks. At necropsy the stents were in good position in all cases and without evidence of peritonitis. Histopathology confirmed permeable anastomoses with collagen scar tissue and continuity of the mucosa and mucosal muscle layers. The San Francisco and Marseille teams performed the first 3 human cases from January to April 2014. All of the included patients refused surgery, and consents were obtained after each patient was fully informed of the novel nature of this endoscopic technique. Institutional review board approval was not required. All procedures were technically and clinically successful without adverse events, except 1 minor adverse event, which was managed endoscopically. All patients received antibiotic prophylaxis and underwent intensive gastric cleansing at the onset of the procedure with either saline solution or iodine. No scientific data are available to recommend which of these approaches to use. One patient had a technical adverse event caused by excessive enlargement of the jejunal site with a needleknife, without compromising the outcome. Fortunately,
www.giejournal.org
Volume 81, No. 1 : 2015 GASTROINTESTINAL ENDOSCOPY 217
Figure 3. Endoscopic view through the stent showing the small-bowel mucosa.
with a rat-tooth forceps. On post-procedure day 2, an oral barium contrast study revealed a patent, leak-free anastomosis, and the patient’s diet was advanced.
RESULTS
NOTES gastroenterostomy with a biflanged lumen-apposing stent
Barthet et al
bypass and duodenal stenting in patients with malignant gastric outlet obstruction would be worthwhile. We also plan to evaluate endoscopic gastrojejunal anastomosis for the management of obesity. Our team currently is performing an experimental study in pigs to assess the nutritional and metabolic impact of endoscopic gastrojejunal anastomosis. Many questions remain, including the optimal length of the jejunal loop and the need for pyloric closure.
this was endoscopically managed without clinical consequences. We believe that creation of the gastric orifice is best achieved with balloon dilation as shown previously in a randomized experimental study.11 For accessing the duodenal or jejunal lumen, we believe the best approach is to puncture with a 19-gauge FNA needle, allowing contrast material injection and fluoroscopic guidance followed by guidewire insertion. This allows passage of a 6F cystotome followed by stent deployment or by use of a stent-delivery system that has an electrocautery tip. All patients tolerated early initiation of dietary intake and could be advanced to a normal diet at 1 month after the procedure. However, it is not clear that a durable anastomosis without an indwelling stent can be achieved or the optimal time the LAS should remain in place. We plan to assess these questions in subsequent studies. The limitations of this study are the small series of only 3 cases and heterogeneous patient characteristics and etiologies of obstruction (benign and malignant). Our team plans a prospective pilot study of gastroduodenal anastomosis by using EUS guidance to direct the guidewire close to the ligament of Treitz. The remaining procedure after intensive cleaning of the stomach with saline solution irrigation will include (1) balloon dilation for the gastric orifice, (2) a 19-gauge FNA needle for accessing the duodenal lumen and grasping the intestine with a forceps in the other channel of the double-operating-channel endoscope, (3) contrast material injection into the duodenal lumen with fluoroscopic guidance and insertion of a guidewire, (4) insertion of the LAS with an electrocautery tip in the duodenal lumen, (5) deployment of the distal flange, (6) withdrawal of the endoscope toward the gastric lumen, and (7) release of the proximal flange into the gastric lumen. The protocol outlined is pending final ethics committee approval. Indications for NOTES endoscopic GI anastomoses are in evolution. Endoscopic gastroduodenal anastomosis could be an alternative to laparoscopic surgery in cases of benign stenosis of the duodenum and will require randomized trials before it can be recommended in clinical practice. Endoscopic gastroduodenal anastomosis also could be used as an alternative to duodenal stent placement in cases of malignant stenosis. In the future, comparing outcomes of this new technique with surgical
1. Von Renteln D, Vassiliou MC, McKenna D, et al. Endoscopic vs laparoscopic gastrojejunal anastomosis for duodenal obstruction: a randomized study in a porcine model. Endoscopy 2012;44:161-8. 2. Vanbiervliet G, Gonzalez JM, Bonin E, et al. Gastrojejunal anastomosis exclusively using the NOTES technique in live pigs: a feasibility and reliability study. Surg Innov 2013;19:409-18. 3. Gonzalez JM, Bonin E, Vanbiervliet G, et al. Feasibility, efficacy and safety of pure transluminal endoscopic gastrojejunal bypass in an outlet obstruction in survival animal model. Endoscopy International Open 2013;1:e31-8. 4. Binmoeller KF, Shah JN. Endoscopic ultrasound-guided gastroenterostomy using a new tool designed for transluminal therapy: a porcine study. Endoscopy 2012;44:499-503. 5. Vanbiervliet G, Garces-Duran R, Garnier E, et al. NOTES gastroenteric anastomosis using a tissue apposing stent: a reproducible and efficient technique in live pigs. Endoscopy 2014;46:871-7. 6. Barthet M, Vanbiervliet G, Gonzalez JM. Innovation and NOTES. Endoscopy 2014;46:346-9. 7. Van Hooft JE, Vleggaar FP, Lemoine O, et al. Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study. Gastrointest Endosc 2010;72:530-5. 8. Kantsevoy SV, Bitner M, Mitrakov A, et al. Endoscopic suturing closure of large defects after endoscopic submucosal dissection is technically feasible, fast, and eliminates the need for hospitalization (with videos). Gastrointest Endosc 2014;79:503-7. 9. Bergström M, Ikeda K, Swain P, et al. Transgastric anastomosis by using flexible endoscopy in a porcine model (with video). Gastrointest Endosc 2006;63:307-12. 10. Chiu PW, Wai Ng EK, Teoh AY, et al. Transgastric endoluminal gastrojejunal anastomosis: technical development from bench to animal study. Gastrointest Endosc 2010;71:390-3. 11. Teoh AY, Chiu PW, Lau JY, et al. Randomized comparative trial of a novel one-step needle sphincterotome versus direct incision and balloon dilation used to create gastrotomies for natural orifice translumenal endoscopic surgery (NOTES) in the porcine model. Surg Endosc 2011;25:3116-21.
218 GASTROINTESTINAL ENDOSCOPY Volume 81, No. 1 : 2015
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