Innovations and brief communications

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Authors

Daisuke Kikuchi1, Akihiro Yamada1, Toshiro Iizuka1, Kosuke Nomura1, Yasutaka Kuribayashi1, Ryusuke Kimura1, Satoshi Yamashita1, Tsukasa Furuhata1, Akira Matsui1, Toshifumi Mitani1, Osamu Ogawa1, Shu Hoteya1, Naohisa Yahagi2, Mitsuru Kaise1

Institutions

1 2

submitted 9. September 2013 accepted after revision 12. June 2014

Bibliography DOI http://dx.doi.org/ 10.1055/s-0034-1377450 Published online: 11.8.2014 Endoscopy 2014; 46: 977–980 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0013-726X Corresponding author Daisuke Kikuchi, MD PhD Department of Gastroenterology Toranomon Hospital 2-2-2 Toranomon, Minato-ku Tokyo 105-8470 Japan Fax: +81-3-35827068 [email protected]

Department of Gastroenterology, Toranomon Hospital, Tokyo, Japan Cancer Center, Keio University, Tokyo, Japan

Background and study aims: Endoscopists must maneuver both endoscope and treatment device during procedures, requiring them to release their hand from the scope to manipulate the treatment device. Aiming to improve this situation, we developed a new device called the Thumb Drive. Patients and methods: The Thumb Drive comprises a controller and catheter. 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 Thumb Drive and fixed with its tip protruding from the endoscope

Introduction !

In many endoscopic procedures, the endoscopist uses the right hand to maneuver both the endoscope and the treatment device, which requires release of the right hand from the scope when manipulating the treatment device. This often compromises the operative view. With the aim of maintaining a good operative view throughout safe and quick endoscopic procedures, we have developed a new endoscopic device, the Thumb Drive, which enables the endoscopist to maneuver the treatment device while still gripping the endoscope and maintaining a good endoscopic view. This report describes the results of testing the Thumb Drive in an ex vivo animal model.

Methods !

Device description The Thumb Drive was developed in collaboration with TOP Corporation, Tokyo, Japan. The Thumb Drive comprises two parts, the controller and the catheter, and is effectively a semi-rigid, loop" Fig. 1). After attachshaped channel extender (● ing the controller to the endoscope’s grip, the catheter is inserted into the forceps channel

tip. A single endoscopist resected 10 lesions in a porcine stomach by endoscopic submucosal dissection (ESD) using the Thumb Drive. Results: All lesions were resected en bloc using this new device without any perforations. The mean incision, dissection, and operative times were 97.2 ± 48.7 seconds, 121.6 ± 53.6 seconds, and 218.8 ± 67.8 seconds, respectively. Conclusions: The Thumb Drive enables the endoscopist to manipulate the treatment device with the thumb while handling the endoscope with the right hand during ESD. Its utility should be examined in in vivo studies as a next step. " Fig. 2 a). The treatment device is then inserted (● into the Thumb Drive and fixed with its tip pro" Fig. 2 b, c). truding from the endoscope tip (● While holding the endoscope with the right hand, the treatment device can be freely manipulated forward and backward by operating the knob of the controller with the thumb of the right " Fig. 2 d, e). Should the endoscopist need hand (● to change his or her grip on the endoscope during the procedure, the controller can be easily removed and repositioned for the new grip " Fig. 2 f; ● " Video 1). (● The operable length of the knob on the controller is adjustable up to 2.5 cm. Therefore, the operator can arbitrarily vary the length of protrusion of the treatment device by up to 2.5 cm. The length of the catheter is adjustable up to 55 cm and the total length of the Thumb Drive is 63 cm. The inner diameter is 2.8 mm and the outer diameter is 4.2 " Fig. 3 shows an endoscope mounted with mm. ● the Thumb Drive and a treatment device.

Ex vivo porcine model We used an excised porcine stomach commercially available for human consumption to avoid ethical conflicts and enable lesions to be easily created. The ex vivo porcine model was prepared by irrigating the stomach for at least 30 minutes to

Kikuchi Daisuke et al. Simultaneous manipulation of endoscope and treatment device … Endoscopy 2014; 46: 977–980

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A new device for simultaneous manipulation of an endoscope and a treatment device during procedures: an ex vivo animal study

Innovations and brief communications

Table 1

Results of endoscopic submucosal dissection (ESD) with the Thumb Drive in 10 lesions in an ex vivo porcine stomach model.

Case number

Incision time, s

Dissection time, s

Operative time, s

Perforation

En bloc resection

1

122

69

191

No

Yes

2

62

37

99

No

Yes

3

216

111

327

No

Yes

4

88

206

294

No

Yes

5

50

155

205

No

Yes

6

80

190

270

No

Yes

7

64

134

198

No

Yes

8

73

73

146

No

Yes

9

88

134

222

No

Yes

10

129

107

236

No

Yes

s, seconds.

remove the contents, closing the duodenum with forceps, and filling the stomach with water to detect leakage. The esophagus was connected to the overtube and fixed within a plastic frame " Fig. 4). (●

Evaluation items

Endoscopic submucosal dissection

Results

Endoscopic submucosal dissection (ESD) was performed by a single endoscopist (D.K.), a board-certified endoscopist of the Japan Gastroenterological Endoscopy Society with experience of more than 300 cases of ESD. A total of 10 lesions located at the lessor curvature of the upper gastric body of an excised porcine stom" Video 1). A GIF ach were resected using the Thumb Drive (● Q200 endoscope (Olympus Optical Co., Ltd., Tokyo, Japan) and Captivator treatment device (Boston Scientific, Natick, Massachusetts, USA) were used. The Captivator was used as a substitute for an ESD knife. The ICC 200 high-frequency generator (ERBE, Tübingen, Germany) was used for incision and dissection in the Auto cut mode using Effect 3, 120 W.

!

We evaluated the incision, dissection, and operative times, and the incidence of perforation.

All lesions were removed by en bloc resection with no associated perforation. The mean incision, dissection, and operative times were 97.2 ± 48.7 seconds, 121.6 ± 53.6 seconds, and 218.8 ± 67.8 " Table 1). seconds, respectively (●

Discussion !

ESD is widely used to excise early-stage cancer, not only in the esophagus, stomach, and colon, but also recently in the pharynx and duodenum [1 – 5]. Despite being an effective treatment method, ESD can be difficult to perform. The degree of difficulty is determined by various factors, including lesion site and size, the presence of hemorrhage or fibrosis, and endoscope maneuverability [6, 7]. Nevertheless, whatever the degree of difficulty, it is important to maintain a good operative view during treatment [8, 9].

Video 1

Online content including Video showing the attachment of the newly developed Thumb Drive to video sequences viewable at: www.thieme-connect.de the endoscope, its method of use, and the endoscopic submucosal dissection (ESD) procedure in the lessor curvature of the upper gastric body of an excised porcine stomach. Use of the Thumb Drive allows the endoscopist to manipulate the treatment device with the thumb of the right hand while holding the endoscope with the rest of the hand, thereby enabling safe and quick endoscopic treatment without compromising the operative view.

Kikuchi Daisuke et al. Simultaneous manipulation of endoscope and treatment device … Endoscopy 2014; 46: 977–980

Fig. 1 The two component parts of the Thumb Drive: the controller (yellow arrow) and the catheter (red arrow).

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

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a

d

b

c

e

f

Fig. 2 Procedure for endoscopic treatment with the Thumb Drive. a The Thumb Drive is attached to the endoscope by fixing the controller to the endoscope’s grip (lower left circle) and inserting the catheter into the forceps channel (upper right circle). b The treatment device is inserted into the Thumb Drive (see inset). c The device is fixed with its tip protruding from the endoscope tip by turning the knob on the controller (see inset). d The endoscopist manipulates the treatment device with the thumb of the right hand while holding the endoscope in the rest of the hand. e The backward and forward motion of the treatment device is controlled by the thumb. f The controller can be easily removed and repositioned, allowing the endoscopist to easily change the grip on the endoscope.

Fig. 4 Endoscopic submucosal dissection (ESD) being performed in an ex vivo porcine stomach model. Fig. 3 An endoscope mounted with the Thumb Drive and a treatment device in position.

Kikuchi Daisuke et al. Simultaneous manipulation of endoscope and treatment device … Endoscopy 2014; 46: 977–980

979

This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

Innovations and brief communications

Innovations and brief communications

During all endoscopic treatment procedures, including ESD, the endoscopist has to release the endoscope to manipulate the treatment device. In an attempt to overcome this limitation, we developed the Thumb Drive device to enable a single endoscopist to insert and withdraw the treatment device using the thumb of the right hand, while manipulating the endoscope with the same hand. The Thumb Drive device is effectively a semi-rigid, loop-shaped channel extender. As it wraps around the outside of the scope, the attached treatment device must be around 200 cm in length. In this study, we used a Captivator as a replacement for the ESD knife. In Japan, the knife typically used for esophageal and colonic procedures is 195-cm long, so it can be used with the Thumb Drive. On the other hand, the knife used for gastric surgery is 165-cm long, so it would need to be elongated to be used with the Thumb Drive. Attachment of the Thumb Drive to the controller region of the endoscope is simple, as is rotation of the Thumb Drive, and the endoscopist can easily change grip during the procedure. Aspiration will not be affected when the Thumb Drive is used because conventional devices can be inserted into the endoscope to manage this. In addition, it is possible to manipulate the scope more or less as usual, and therefore we believe the Thumb Drive shows promise for application in routine examinations. The present study was conducted by a single endoscopist who developed the Thumb Drive and was sufficiently familiar with its operation. Clearly, operators will need to learn how to use the Thumb Drive and the initial learning curve may affect procedure duration and safety. Going forward, studies are required to compare the Thumb Drive technique with conventional methods, particularly during the learning curve. Moreover, since it is theoretically possible for the Thumb Drive to be used for endoscopic mucosal resection, endoscopic retrograde cholangiopancreatography (ERCP), endoscopic injection sclerotherapy, and peroral endoscopic myotomy, further studies are needed to verify the different types of treatment for which the Thumb Drive can be used, as well as the appropriate timing of its use in each procedure. Such studies should be randomized and prospective to compare the safety and efficacy of the Thumb Drive with conventional methods.

In conclusion, the Thumb Drive facilitated simultaneous manipulation of the endoscope and treatment device, making it possible to perform ESD quickly and safely. As the present results were based on the experience of a single endoscopist who performed a limited number of ex vivo procedures, in the next step toward clinical application, the utility and safety of the Thumb Drive will need to be verified in an in vivo study. Competing interests: The patent application for this device is in collaboration with TOP Corporation (Tokyo, Japan). The prototype was designed and produced by TOP Corporation. No remuneration or compensation has been received in connection with this study.

References 1 Hoteya S, Iizuka T, Kikuchi D et al. Benefits of endoscopic submucosal dissection according to size and location of gastric neoplasm, compared with conventional mucosal resection. J Gastroenterol Hepatol 2009; 24: 1102 – 1106 2 Takahashi H, Arimura Y, Masao H et al. Endoscopic submucosal dissection is superior to conventional endoscopic resection as a curative treatment for early squamous cell carcinoma of the esophagus (with video). Gastrointest Endosc 2010; 72: 255 – 264 3 Saito Y, Uraoka T, Yamaguchi Y et al. A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video). Gastrointest Endosc 2010; 72: 1217 – 1225 4 Iizuka T, Kikuchi D, Hoteya S et al. Endoscopic submucosal dissection for treatment of mesopharyngeal and hypopharyngeal carcinomas. Endoscopy 2009; 41: 113 – 117 5 Honda T, Yamamoto H, Osawa H et al. Endoscopic submucosal dissection for superficial duodenal neoplasms. Dig Endosc 2009; 21: 270 – 274 6 Kikuchi D, Iizuka T, Hoteya S et al. Usefulness of endoscopic ultrasound for the prediction of intraoperative bleeding of endoscopic submucosal dissection for gastric neoplasms. J Gastroenterol Hepatol 2011; 26: 68 – 72 7 Jeong JY, Oh YH, Yu YH et al. Does submucosal fibrosis affect the results of endoscopic submucosal dissection of early gastric tumors? Gastrointest Endosc 2012; 76: 59 – 66 8 Iizuka T, Kikuchi D, Hoteya S et al. A new technique for pharyngeal endoscopic submucosal dissection: peroral countertraction (with video). Gastrointest Endosc 2012; 76: 1034 – 1038 9 Sakamoto N, Osada T, Shibuya T et al. Endoscopic submucosal dissection of large colorectal tumors by using a novel spring-action S-O clip for traction (with video). Gastrointest Endosc 2009; 69: 1370 – 1374

Kikuchi Daisuke et al. Simultaneous manipulation of endoscope and treatment device … Endoscopy 2014; 46: 977–980

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A new device for simultaneous manipulation of an endoscope and a treatment device during procedures: an ex vivo animal study.

Endoscopists must maneuver both endoscope and treatment device during procedures, requiring them to release their hand from the scope to manipulate th...
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