JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES Volume 24, Number 4, 2014 ª Mary Ann Liebert, Inc. DOI: 10.1089/lap.2013.0504

Development of New Devices for Translumenal Endoscopic Esophageal Anastomosis Tetsuya Ishimaru, MD, PhD, Akira Hatanaka, MD, Shinya Takazawa, MD, Kenichiro Konishi, MD, and Tadashi Iwanaka, MD, PhD

Abstract

Aim: This study aimed to develop new devices for translumenal endoscopic esophageal anastomosis—a stent and a ligating device—and to confirm the feasibility of our novel procedure using those devices. Materials and Methods: We designed a ligating device as an overtube whose tip worked like the EVL device (Sumitomo Bakelite Co. Ltd., Tokyo, Japan). The newly developed procedure for anastomosis is as follows: a silicone elastic band, which was released from the device located at the upper esophagus, and a custom-made expandable stent, which was expanded by the balloon catheter in the lower esophagus, tightened the upper and lower esophageal walls. After producing the devices, we performed the anastomosis procedure in porcine models. Results: A ligating device and an expandable stent were developed for this study. An ex vivo feasibility study was performed in three porcine models. Endoscopic visualization revealed that all steps in this procedure were technically successful. The median time needed to perform this procedure was 24 (range, 19–25) minutes. Patency of the anastomosis was confirmed in all specimens. Conclusions: Translumenal esophagoesophageal anastomosis using the new devices was feasible. The procedure time was sufficiently short for clinical use. An in vivo survival study is needed to confirm the safety and reliability of this procedure.

Materials and Methods

Introduction

T

he management of long-gap pure esophageal atresia remains challenging. Minimally invasive approaches using laparoscopy and/or thoracoscopy have been reported, but a multistage procedure is usually performed for patients with this disease, and the efficacy of conventional procedures remains unsatisfactory.1–9 We reported a laparoscopic gastric pull-up using natural orifice translumenal endoscopic surgery (NOTES; American Society for Gastrointestinal Endoscopy [Oak Brook, IL] and Society of American Gastrointestinal and Endoscopic Surgeons [Los Angeles, CA]) techniques and succeeded in translumenal esophagoesophageal anastomosis in acute nonsurvival experiments.10 In addition, an improved method of translumenal esophageal anastomosis was also shown in the ex vivo setting.11 However, those previous procedures were very complicated and associated with risk, and there remained room for further refinement of the methods for this procedure. The aim of this study was to develop novel devices to make esophageal anastomosis using NOTES simpler and safer.

Concept of translumenal endoscopic esophageal anastomosis The concept of the novel procedure using new devices was composed of the following steps: (1) The new ligating device, an overtube attached to an elastic band at the tip, was inserted close to the blind end. (2) The blind end of the upper esophagus was incised, and the scope was advanced out of the esophagus (Fig. 1a). (3) A traction suture was placed at the blind end using a BraceBar (Olympus Medical Systems Corp., Tokyo, Japan), a prototype of the double T-bar suturing device originally developed to establish endoscopic fullthickness closure of large gastric perforations (Fig. 1b). (4) A balloon catheter covered with a custom-made stent (a new device) was inserted into the lower esophagus, and the stent was expanded by the balloon in the lower esophagus (Fig. 1c). (5) The traction suture and the balloon catheter were pulled so that the end of the upper esophagus was inverted and the lower esophagus was pulled into the upper esophagus (Fig. 1d and e). (6) The elastic band was released over the stent (Fig. 1f ). (7) The anastomosis was completed after the ligated

Department of Pediatric Surgery, The University of Tokyo Hospital, Tokyo, Japan.

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FIG. 1. Concept of translumenal endoscopic esophageal anastomosis using new devices. (a) A new ligating device, which is an overtube attached to an elastic band at the tip, is inserted close to the blind end, and the scope is advanced out of the upper esophagus. (b) A traction suture is placed at the blind end. (c) A balloon catheter covered with a custom-made stent is inserted into the lower esophagus. (d) The traction suture and the balloon catheter are pulled. (e) The end of the upper esophagus is inverted, and the lower esophagus is pulled into the upper esophagus. (f ) The elastic band is released over the stent. (g) The scope, catheter, and ligating device (the overtube) are removed. (h) Anastomosis is completed after the ligated tissue becomes necrotic and drops off. tissue became necrotic and dropped off together with the stent (Fig. 1g and h). Development of the devices A ligating device and an expandable stent were developed for this study. We designed the ligating device as an overtube whose tip worked like the EVL device (Sumitomo Bakelite Co. Ltd., Tokyo, Japan). The tip of the device was produced by Yasuhisa Koki Bio Mechanics Co., Ltd. (Tokyo) so that it could be attached to the tip of a TOP overtube (catalog number 16632; TOP Corp., Tokyo). The stent was made by EMIKKU Co., Ltd. (Tokyo). The size of the stent before or after balloon dilatation was decided based on the diameter of the balloon catheter (15-mm CRE wireguided balloon dilator; Boston Scientific Corp., Natick, MA) used in the ex vivo feasibility study.

closed at both ends with interrupted sutures. The new ligating device was inserted close to the blind end of the upper esophagus and mounted in a phantom of the human upper body. The lower esophagus and the whole stomach were also set in the phantom (Fig. 2).

Ex vivo feasibility study The study protocol was approved by the Animal Care and Use Committee of The University of Tokyo. An ex vivo feasibility study was performed using three porcine models. Three esophagi and whole stomachs were harvested from 120-kg pigs, and each esophagus was transected at the middle and

FIG. 2.

Experimental setting.

270 A two-channel endoscope (EVIS gastrointestinal videoscope GIF type 2T240; Olympus Medical Systems Corp.) was introduced into the upper esophagus. The center of the blind end was incised, and the scope was advanced out of the esophagus. After the lower esophagus was identified, the scope was withdrawn back into the upper esophagus, and a traction suture was placed at the blind end using a BraceBar. The scope was again advanced out of the upper esophagus, the blind end of the lower esophagus was grasped, and a small hole was made at its center. A guidewire was inserted into the lower esophagus through this hole, and the hole was dilated using an 8-mm CRE wireguided balloon dilator. After the catheter was removed, leaving the guidewire in place, a 15-mm CRE wireguided balloon dilator covered with a custom-made expandable stent was inserted into the lower esophagus, and the stent was expanded by the balloon. The scope was withdrawn back into the upper esophagus, leaving both the stent and the balloon catheter in place, and the traction suture was grasped by a forceps. The scope, together with the catheter and the forceps, was pulled so that the end of the upper esophagus was inverted, and the lower esophagus was pulled into the upper esophagus. An elastic band was released from the ligating device over the stent. After the balloon was deflated, the catheter and the guidewire were removed, leaving the stent in place.

FIG. 3. Developed ligating device. (a) Overall view. The mechanism of this equipment is the same as an EVL device. (b) This equipment is used after being attached to the tip of the overtube. A silicone-made elastic band (arrow) is set.

ISHIMARU ET AL. Results The developed ligating device is shown in Figure 3. Its maximum diameter was 28 mm, and it could be attached to the tip of the overtube. A silicone elastic band with an internal diameter of 9.8 mm was attached to the device and could be easily released from the device by air insufflation using a syringe. The stent (Fig. 4) was made of SUS304 stainless steel, and its length, the outer diameter, and inner diameter before expansion were 38.3, 3.6, and 3.2 mm, respectively. It could be easily expanded up to 18 mm by the balloon and kept in rigid cylindrical shape after the balloon was deflated. Endoscopic visualization indicated that the procedures were technically successful under endoscopic visualization. Endoscopic views and the appearance of the exterior of the esophagus during the procedure are shown in Figure 5. The median time of this procedure was 24 (range, 19–25) minutes. After the procedure, a bronchoscope was introduced into the stent, and the patency of the anastomosis was confirmed (Fig. 6). The specimens were carefully examined after the experiment (Fig. 7). All silicone bands were released just over the stent. The upper and the lower esophagus between the band and the stent were tightened in all specimens. Lumens of all stents were maintained without being collapsed by the contraction force of the bands.

FIG. 4. Expandable custom-made stent. (a) The stent before (left) and after (right) expansion. (b) The stent is attached over the balloon catheter.

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FIG. 5. Endoscopic views and outer appearance during the procedure. (a) A guidewire is inserted into the lower esophagus. (b) The stent covering with the balloon catheter is advanced through the overtube. (c) The stent is expanded by the balloon. (d and e) The end of the upper esophagus is inverted by pulling the traction suture, and the lower esophagus is pulled into the upper esophagus by pulling the catheter: (d) endoscopic view and (e) outer appearance. Discussion We developed a ligating device and a custom-made expandable stent for translumenal esophageal anastomosis and confirmed the feasibility of our new procedure. Our aim is to treat patients with long-gap esophageal atresia using a mini-

FIG. 6. Internal view of the stent after the procedure. Patency of the anastomosis is confirmed.

mally invasive approach and to provide them with a good quality of life. We have been attempting to develop a new procedure, a gastric pull-up using the combined approach of laparoscopic surgery and NOTES.10 Translumenal esophageal anastomosis was crucial to achieving our goal, but previous methods were very complicated and associated with a risk to adjacent organs.10,11 To solve these problems, we developed new devices and made improvements in methodology. First, we changed the way to place the anchor suture. In our previous study,11 the blind end of the upper esophagus was punctured blindly to place the anchor suture. Then, the blind end was incised, and the scope was advanced out of the esophagus. In contrast, in the present study the blind end was first incised, and the anchor suture was placed after the outside of the upper esophagus was examined. We believe that this modification results in a decrease in the risk of injury to surrounding organs. Second, a new technique was adopted for anastomosing the esophagus. In the previous study,11 two esophageal tissues were ligated between the tube inserted via the transgastric route and the band that had been released from the ligating device. Manipulating the ligating device was complicated and time-consuming because the esophagus was a narrow tubular organ that did not provide enough space for handling the endoscope. In this study, the esophageal tissues were tightened between the elastic band released from the

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ISHIMARU ET AL. can be performed in the supine position, has the advantage of preventing complications related to the body position. This study has several limitations. To begin with, the experiments were ex vivo. Considering future clinical application, we must confirm that the stent can be evacuated without any complications after the anastomosis is completed. In addition, we have yet to confirm that the compressed tissues between the band and the stent become necrotic and drop off. In the future animal survival experiments should be performed to evaluate adjustments between the compression force of the band and the strength of the stent. The final target of our procedure is neonates or infants with esophageal atresia. However, the devices developed in this study were too large to be used in infants. That was inevitable because the endoscope and instruments used in the current study were those developed for adults. We hope that the industry will have an increased interest in pediatric surgery and develop smaller devices for children. Despite limitations, this study showed the feasibility of esophageal anastomosis for NOTES, which can be accomplished only via the oral route. The current procedure was shown to be simpler and safer than our previous one,11 and the developed devices played a vital role in this procedure. Acknowledgments This study was supported by an IPEG 2012 research grant and a grant (number 23592626) from the Ministry of Education, Culture, Sports, Science and Technology of Japan. Disclosure Statement

FIG. 7. Specimen after the procedure. (a) Overall view. The upper and lower esophagi are anastomosed by the band and the stent. (b) Anastomosed part. The band (arrow) tightens the two tissues (i.e., the upper and the lower esophagi). The stent maintains their lumen against the band.

ligating device and the stent, which was inserted orally. The mechanism of the ligating device was the same as an EVL device. The piston is moved by increased pressure after air insufflation through a syringe, and the piston pushes the band, which is then released. The procedure was simpler than the previously described procedure, and the median procedure time was reduced from 31 minutes to 24 minutes. With this improved procedure, the stent could be inserted orally, eliminating the need to use a gastrostomy as the route. This means that the indications for this procedure could expand to patients without a gastrostomy. Some studies have reported a method of bowel anastomosis for NOTES, and most were related to colorectal surgery.12–15 Only a few studies tried to establish a procedure for esophageal anastomosis for NOTES, and the use of a single transthoracic trocar was cited as useful in the procedure.16,17 However, we avoided the use of trocars in the thoracic region because thoracic incisions, even when small, are painful. Moreover, our procedure might be applicable to esophagectomy, which is a major surgery in adults. That operation is generally performed with the patient in the lateral position, but the lateral position tends to cause more respiratory complications such as postoperative pneumonia or atelectasis compared with the supine position. We believe that our procedure, which

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NEW DEVICES FOR NOTES ESOPHAGEAL ANASTOMOSIS 9. Iwanaka T, Kawashima H, Tanabe Y, Aoki T. Laparoscopic gastric pull-up and thoracoscopic esophago-esophagostomy combined with intrathoracic fundoplication for long-gap pure esophageal atresia. J Laparoendosc Adv Surg Tech A 2011;21:973–978. 10. Ishimaru T, Iwanaka T, Kawashima H, et al. A pilot study of laparoscopic gastric pull-up by using the natural orifice translumenal endoscopic surgery technique: A novel procedure for treating long-gap esophageal atresia (type a). J Laparoendosc Adv Surg Tech A 2011;21:851–857. 11. Ishimaru T, Iwanaka T, Hatanaka A, Kawashima H, Terawaki K. Translumenal esophageal anastomosis for natural orifice translumenal endoscopic surgery: An ex vivo feasibility study. J Laparoendosc Adv Surg Tech A 2012;22:724–729. 12. Wall J, Diana M, Leroy J, et al. MAGNAMOSIS IV: Magnetic compression anastomosis for minimally invasive colorectal surgery. Endoscopy 2013;45:643–648. 13. Park SJ, Lee KY, Choi SI, et al. Pure NOTES rectosigmoid resection: Transgastric endoscopic IMA dissection and transanal rectal mobilization in animal models. J Laparoendosc Adv Surg Tech A 2013;23:592–595. 14. Leroy J, Barry BD, Melani A, Mutter D, Marescaux J. No-scar transanal total mesorectal excision: The last step to pure NOTES for colorectal surgery. JAMA Surg 2013;148:226–230; discussion 231.

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15. Demura Y, Ishikawa N, Hirano Y, Inaki N, Matsunoki A, Watanabe G. Transrectal robotic natural orifice translumenal endoscopic surgery (NOTES) applied to intestinal anastomosis in a porcine intestine model. Surg Endosc 2013 Aug 27 [Epub ahead of print]. doi: 10.1007/s00464-013-3117-y. 16. Henriques-Coelho T, Soares TR, Miranda A, Moreira-Pinto J, Correia-Pinto J. Transthoracic single port with peroral assistance: An animal experiment to assess a less invasive technique for human esophageal atresia repair. J Laparoendosc Adv Surg Tech A 2012;22:1021–1027. 17. Rolanda C, Silva D, Branco C, Moreira I, Macedo G, CorreiaPinto J. Peroral esophageal segmentectomy and anastomosis with single transthoracic trocar: A step forward in thoracic NOTES. Endoscopy 2011;43:14–20.

Address correspondence to: Tetsuya Ishimaru, MD, PhD Department of Pediatric Surgery The University of Tokyo Hospital 7-3-1 Hongo Bunkyo, Tokyo 113-8655 Japan E-mail: [email protected]

Development of new devices for translumenal endoscopic esophageal anastomosis.

This study aimed to develop new devices for translumenal endoscopic esophageal anastomosis-a stent and a ligating device-and to confirm the feasibilit...
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