Original Paper Published online: January 20, 2015

Digestion 2015;91:26–29 DOI: 10.1159/000368767

Ex vivo Comparison Study of Smart Shooter®, a New Endoscopic Device for Safe and Speedy Treatment Daisuke Kikuchi Yasutaka Kuribayashi Toshiro Iizuka Kosuke Nomura Ryusuke Kimura Akihiro Yamada Satoshi Yamashita Tsukasa Furuhata Akira Matsui Toshifumi Mitani Osamu Ogawa Shu Hoteya Mitsuru Kaise Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan

Abstract Background: In many endoscopic procedures, the operative view can be compromised when manipulating the treatment device because the endoscopists must release their hand from the endoscope. We have developed a new device called the Smart Shooter® (SS) for simultaneous manipulation of the endoscope and treatment device, and evaluated the utility of the SS compared with the conventional method. Methods: The SS is a semirigid, loop-shaped channel extender that enables endoscopists to manipulate the treatment device with the thumb of the right hand while holding the endoscope with the same hand. We conducted a comparative study of gastric endoscopic submucosal dissection (ESD) and esophageal injection sclerotherapy (EIS) in a porcine model to compare the utility of the SS method with the conventional method. Results: In gastric ESD, all lesions were resected en bloc with no perforation. The mean opera-

© 2015 S. Karger AG, Basel 0012–2823/15/0911–0026$39.50/0 E-Mail [email protected] www.karger.com/dig

tive time was significantly shorter with the SS method than with the conventional method (287.5 ± 155.4 vs. 403.5 ± 215.6 s, p = 0.04). In esophageal EIS, 4 paravenous injections were given with the SS method and 5 were given using the conventional method. Similarly, the mean operative time was significantly shorter with the SS method than with the conventional method (19.0 ± 7.8 vs. 23.8 ± 10.0 s, p = 0.04). Conclusion: Use of the SS enabled a shorter operative time for gastric ESD and esophageal EIS with no adverse events. The present results suggest that the SS can contribute to safe and speedy endoscopic treatment. © 2015 S. Karger AG, Basel

Introduction

Advances in endoscopic treatment have led to the development of various endoscopic procedures for treating many diseases of the gastrointestinal tract [1, 2]. Endoscopic treatment is less invasive than surgery and may help to maintain a patient’s quality of life. However, the degree of difficulty of endoscopic maneuvers increases when the disorder to be treated is complicated. Although Daisuke Kikuchi, MD, PhD Department of Gastroenterology Toranomon Hospital 2-2-2 Toranomon, Minato-ku, Tokyo 105-8470 (Japan) E-Mail dkiku1230 @ gmail.com

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Key Words New device · Endoscopic submucosal dissection · Esophageal injection sclerotherapy · Training model · Endoscopy

Methods Smart Shooter® The SS was developed in collaboration with TOP Corporation, Tokyo, Japan, and approved by the Japanese government. We have previously reported its structure in detail [3]. Briefly, the SS comprises two parts, the controller and the catheter (fig. 1). After attaching the controller to the endoscope’s grip, the catheter is inserted into the forceps channel. The treatment device is then inserted into the SS and fixed with its tip protruding from the endoscope tip. While holding the endoscope with the right hand, the treatment device can be freely manipulated by operating the knob of the controller with the thumb of the same hand. Should the endoscopist need to change his or her grip of the endoscope during the procedure, the controller can be easily removed and repositioned. Experiment and Evaluation Items To evaluate the utility of the SS for endoscopic treatment, we created ex vivo porcine models of gastric endoscopic submucosal dissection (ESD) and esophageal injection sclerotherapy (EIS). Two endoscopists each performed ESD on 20 lesions (10 by the SS method and 10 by the conventional method) and similarly performed EIS on 20 lesions, for a total of 40 lesions in each model (20 by the SS method and 20 by the conventional method). The evaluation items for ESD were en bloc resection rate, perforation rate, total operative time, incision time and dissection time, and those for EIS were the number of paravenous injections and the total operative time to intravenous injection.

Results

Endoscopic Submucosal Dissection Table 1 shows the results of ESD. All lesions were resected by en bloc resection with no associated perforation. The mean operative time for both endoscopists was significantly shorter with the SS method than with the conventional method (287.5 ± 155.4 vs. 403.5 ± 215.6 s, p = 0.04). The mean incision time was shorter, although not significantly, compared with the SS method (123.6 ± 63.2 vs. 173.2 ± 107.7 s, p = 0.11). The mean dissection time was also significantly shorter with the SS method (163.9 ± 108.3 vs. 230.3 ± 140.7 s, p = 0.04). Esophageal Injection Sclerotherapy Table 2 shows the results of EIS. Four paravenous injections were given in the SS method and 5 were given in the conventional method. The mean operative time to intravenous injection was significantly shorter with the SS method than with the conventional method (19.0 ± 7.8 vs. 23.8 ± 10.0 s, p = 0.04).

Discussion

Ex vivo Porcine Models An ex vivo porcine model of gastric ESD (fig. 2) was prepared by irrigating the stomach for at least 30 min to remove the contents. After clean-up, the esophagus was connected to the overtube and fixed within a plastic frame (fig. 2a). We then made artificial 10-mm lesions at the lesser curvature of the upper gastric body (fig.  2b). For the procedure, we used a GIF Q200 gastroscope (Olympus Optical Co. Ltd., Tokyo, Japan) and a Captivator ESD knife (Boston Scientific, Natick, Mass., USA). The esophageal EIS model (fig. 3a, b) was prepared as follows. A longitudinal incision of about 5 cm was made on the outer membrane of the lower esophagus of a porcine model, and a plastic simulated blood vessel of 3 mm in diameter (provided in a blooddrawing practice kit; Fuso Rubber Industry Co. Ltd., Saitama, Japan) was inserted into the submucosal layer and fixed with 5 stitches. A mixture of indigo carmine and water was infused into the simulated blood vessel and the oral end was clamped. A 23-gauge local injection needle (TOP Corporation) was used.

In most endoscopic procedures, treatment devices are used after being inserted through the forceps channel; for example, endoclip or hemostatic forceps for endoscopic hemostasis, endosnare for endoscopic mucosal resection or polypectomy, knives for ESD and peroral endoscopic myotomy [4], or needles for EIS. Endoscopists have to maneuver both the endoscope and treatment devices simultaneously with their right hand, meaning that the endoscope must be released to manipulate the treatment device. In this situation the endoscopic view can be compromised. To maintain a good operative view, endoscopists either have to ask an assistant to hold the endoscope while manipulating the treatment device, or must continue holding the endoscope while the assistant manipulates the treatment device. In either situation, good cooperation between the endoscopist and the assistant is crucial but can be difficult to achieve. Another limitation of the conventional approach is that the assistant must have a certain level of knowledge and experience of endoscopic treatment. Thus, an ideal method is one that enables the endoscopist to maintain a good operative view while manipulating the treatment device. The SS enables the endoscopist to manipulate the treatment device with the right thumb while maintaining the operative view by holding the endoscope in the rest of the hand, which is close to the ideal situation.

New Endoscopic Device for Safe, Speedy Treatment

Digestion 2015;91:26–29 DOI: 10.1159/000368767

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multiple factors determine technical difficulty, it is always important to maintain a good operative view to achieve safe and speedy endoscopic treatment. We have developed a new device called the Smart Shooter® (SS) that enables the endoscopist to maneuver the treatment device while gripping the endoscope and maintaining a good operative view. Here we compare the SS method with the conventional method in an ex vivo porcine model.

Color version available online

Fig. 1. Photographs of the SS: the controller

(yellow arrow; colors refer to the online version only) and catheter (red arrow; a), and an endoscope mounted with the SS and a treatment device (b).

a

Fig. 2. Ex vivo porcine model of gastric ESD: appearance of the ESD model (a) and the endoscopic view (b).

a

b

Fig. 3. Ex vivo porcine model of EIS: appearance of the EIS model (a) and the endoscopic view (b).

a

b

Color version available online

Color version available online

b

Table 1. Operative parameters of the gastric ESD model Conventional method

Lesions En bloc resections Perforations Incision time, s Dissection time, s Total operative time, s

SS method

Table 2. Operative parameters of the EIS model p value

20 20 20 (100) 20 (100) 0 (0) 0 (0) 173.2 ± 107.7 123.6 ± 63.2 0.11 230.3 ± 140.7 163.9 ± 108.3 0.04 403.5 ± 215.6 287.5 ± 155.4 0.04

Lesions Paravenous injections Total operative time, s

Conventional SS method method

p value

20 5 (25) 23.8 ± 10.0

n.s. 0.04

20 4 (20) 19.0 ± 7.8

Values are presented as n (%) or mean ± SD.

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Digestion 2015;91:26–29 DOI: 10.1159/000368767

Kikuchi et al.

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Values are presented as n (%) or mean ± SD.

Use of the SS significantly reduced the operative time in both ESD and EIS. In the present experiments, all insertions and extractions of treatment devices were successfully performed using the SS. However, the advantages and disadvantages of using the SS in actual clinical settings need to be discussed. Use of the SS reduced the operation time in this ex vivo porcine model where the complicating factors, such as heartbeat, breathing or peristalsis, had been eliminated. The effectiveness of the SS may be greater in actual clinical settings where such factors make it difficult to maintain a clear endoscopic view. Therefore, its usefulness should be verified in prospective randomized clinical studies. We selected gastric ESD and esophageal EIS for the present experiments using a porcine model. In ESD, a clinical situation can be easily simulated by making artificial lesions at preferred sites, and the usefulness of ESD training models using a porcine stomach has been demonstrated in many studies [5, 6]. However, no studies have reported training models for treating esophageal varices. In the present models, we used a simulated blood vessel provided in a blood-drawing practice kit. Although the tactility of inserting a simulated vessel may differ from that during real endoscopic treatment, the procedure is the same and its effectiveness for training purposes is promising. Use of the SS has several limitations. One of them is the length of the device. The SS is a semirigid, loop-shaped

device resembling a channel extender. A certain length is required as the device forms a loop when connected to an endoscope. Another drawback is that it is not as easy to change the gripping portion of the endoscope compared with when not using the SS. The endoscopist’s right hand usually moves quickly over the endoscope to change the gripping portion, but the SS interferes with this motion and may result in reduced maneuverability of the endoscope. On the other hand, use of the SS enables endoscopic manipulations that could not be performed with a conventional endoscope. For example, during ESD with the SS, incision and dissection could be performed by manipulating the device with the thumb while holding the endoscope and maintaining a fixed view. Given the training and learning curves for using the SS, one must be familiar with endoscopic manipulations using the SS before using the device in a clinical setting [7–9]. In conclusion, use of the SS enables safer and faster operations in both ESD and EIS compared with conventional procedures. As the present results were based on the use of an ex vivo porcine model, we intend to verify its usefulness in various clinical settings of endoscopic treatment.

Disclosure Statement None.

References

New Endoscopic Device for Safe, Speedy Treatment

treatment device during procedures: an ex vivo animal study. Endoscopy 2014; 46: 977– 980. 4 Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S: Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy 2010;42:265–271. 5 Tanaka S, Morita Y, Fujita T, Wakahara C, Ikeda A, Toyonaga T, Azuma T: Ex vivo pig training model for esophageal endoscopic submucosal dissection (ESD) for endoscopists with experience in gastric ESD. Surg Endosc 2012;26:1579–1586. 6 González N, Parra-Blanco A, Villa-Gómez M, Gamba A, Taullard A, Silveira A, Sanguinetti A, Olano C, Cohen H: Gastric endoscopic submucosal dissection: from animal model to

Digestion 2015;91:26–29 DOI: 10.1159/000368767

patient. World J Gastroenterol 2013;19:8326– 8334. 7 Gotoda T, Ho KY, Soetikno R, Kaltenbach T, Draganov P: Gastric ESD: current status and future directions of devices and training. Gastrointest Endosc Clin N Am 2014; 24: 213– 233. 8 Sakamoto T, Sato C, Makazu M, Sekiguchi M, Mori G, Yamada M, Kinjo Y, Turuki E, Abe S, Otake Y, Nakajima T, Matsuda T, Saito Y: Short-term outcomes of colorectal endoscopic submucosal dissection performed by trainees. Digestion 2014;89:37–42. 9 Berr F, Wagner A, Kiesslich T, Friesenbichler P, Neureiter D: Untutored learning curve to establish endoscopic submucosal dissection on competence level. Digestion 2014;89:184– 193.

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1 Hoteya S, Matsui A, Iizuka T, Kikuchi D, Yamada A, Yamashita S, Furuhata T, Domon K, Nakamura M, Mitani T, Ogawa O, Kasie M: Comparison of the clinicopathological characteristics and results of endoscopic submucosal dissection for esophagogastric junction and non-junctional cancers. Digestion 2013; 87:29–33. 2 Iizuka T, Kikuchi D, Hoteya S, Yahagi N, Takeda H: Endoscopic submucosal dissection for treatment of mesopharyngeal and hypopharyngeal carcinomas. Endoscopy 2009; 41: 113–117. 3 Kikuchi D, Yamada A, Iizuka T, Nomura K, Kuribayashi Y, Kimura R, Yamashita S, Furuhata T, Matsui A, Mitani T, Ogawa O, Hoteya S, Yahagi N, Kaise M: A new device for simultaneous manipulation of an endoscope and

Ex vivo comparison study of smart Shooter®, a new endoscopic device for safe and speedy treatment.

In many endoscopic procedures, the operative view can be compromised when manipulating the treatment device because the endoscopists must release thei...
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