Annual Report 2017

Division of Surgical Technology

Masaaki Ito, Takahiro Kinoshita, Nobuyoshi Takeshita

Introduction

 The main purpose of the Division of Surgical Technology is to develop surgical devices that are truly necessary, to deliver them to the clinical fields, and to prove their efficacy and safety through clinical trials.

 The three main elements of our innovation are creating devices reflecting true needs in the medical field, practicing with the devices in clinical trials, and connecting our innovations to the wider world.

 On the basis of the collaboration between clinical surgeons and engineers in the innovating group "NEXT conference" (in 2016), the NEXT (Center of New Surgical and Endoscopic Development for Exploratory Technology) was founded this year. In cooperation with the NEXT, we started promoting the surgical device development consisting of clinical need selection, prototype design, POC (Proof of Concept) establishment, validation, and clinical trials.

Our team and what we do

1. Cooperation with the NEXT

 We organized the sugical device development in cooperation with the NEXT, based on discussions between professionals consisting of surgeons and coordinators of surgical innovation, intellectual property and pharmaceutical affairs.

2. Development of a novel device for ablation treatment

 Aiming to enhance accuracy and safety in local ablation treatments, we conduct research and development on a novel device which can perform ablation of tumors by laser irradiation. The laser irradiation is performed through optical fibers which are inserted into the vicinity of tumors.

3. Surgical robotic system innovated by the NCC- certified venture company, A-Traction Inc.

 The NCC (National Cancer Center)-certified venture company, A-Traction Inc. established in 2015, develops an innovative surgical robotic system. This system can support laparoscopic surgery as an assistant beside a surgeon. A-Traction Inc. produced a prototype of the system and verified basic motions.

4. Activity of regional cooperation group for surgical innovation, C-Square

 In the regional cooperation group "C-Square", consisting of Chiba Prefecture, Chiba Industry Advancement Center, Chiba University, and the National Cancer Center Hospital East (NCCHE), we collected and selected four clinical needs in the NCCHE, and matched them with regional industrial technologies through the symposium "C-Square EXPO". Then, new surgical devices started to be developed.

Clinical trials

Create supportive infrastructure for surgical innovation

 We aim to establish a clinical trial infrastructure for surgical innovation in the NCCHE. Surgical clinical trials about our established devices started from 2017.

Education

 We held regular in-house seminars to teach about surgical device innovations for the development of human resources.

Future prospects

 We are going to establish a clinical support team for early-phase surgical device innovations and aim to make a road-map for surgical device innovations.

List of papers published in January 2017 - March 2018

Journal

 1. Sakai Y, Komai Y, Saito N, Ito M, Sakuraba M. Analysis of a Surgical Treatment for Persistent Urorectal Fistulas after Radical Cancer Surgery: A Comparison of Prostate Cancer and Rectal Cancer. Urol Int, 99:56-62, 2017

 2. Nishigori H, Ito M, Nishizawa Y. A novel transanal tube designed to prevent anastomotic leakage after rectal cancer surgery: the WING DRAIN. Surg Today, 47:513-520, 2017

 3. Noguchi K, Nishizawa Y, Komai Y, Sakai Y, Kobayasi A, Ito M, Saito N. Efficacy of an additional flap operation in bladder-preserving surgery with radical prostatectomy and cystourethral anastomosis for rectal cancer involving the prostate. Surg Today, 47:1119-1128, 2017

 4. Yamamoto S, Hinoi T, Niitsu H, Okajima M, Ide Y, Murata K, Akamoto S, Kanazawa A, Nakanishi M, Naitoh T, Kanehira E, Shimamura T, Suzuka I, Fukunaga Y, Yamaguchi T, Watanabe M. Influence of previous abdominal surgery on surgical outcomes between laparoscopic and open surgery in elderly patients with colorectal cancer: subanalysis of a large multicenter study in Japan. J Gastroenterol, 52:695-704, 2017

 5. Tanaka K, Okuda J, Yamamoto S, Ito M, Sakamoto K, Kokuba Y, Yoshimura K, Watanabe M. Risk factors for anastomotic leakage after laparoscopic surgery with the double stapling technique for stage 0/I rectal carcinoma: a subgroup analysis of a multicenter, single-arm phase II trial. Surg Today, 47:1215-1222, 2017

 6. Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg, 266:201-207, 2017

 7. Yokota M, Ito M, Nishizawa Y, Kobayashi A, Saito N. The Impact of Anastomotic Leakage on Anal Function Following Intersphincteric Resection. World J Surg, 41:2168-2177, 2017

 8. Matsunaga R, Nishizawa Y, Saito N, Kobayashi A, Ohdaira T, Ito M. Quantitative evaluation of 3D imaging in laparoscopic surgery. Surg Today, 47:440-444, 2017

 9. Matsunaga R, Nishizawa Y, Saito N, Yokota M, Hayashi R, Ito M. Anal Function after Surgery for Low-Lying Rectal Cancer: Comparison of Mechanical and Hand-Sewn Coloanal Anastomosis. Dig Surg, 34:469-475, 2017

10. Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. The lancet. Gastroenterology & hepatology, 2:261-268, 2017

11. Sasaki T, Ito Y, Ohue M, Kanemitsu Y, Kobatake T, Ito M, Moriya Y, Saito N. Postoperative Chemoradiotherapy After Local Resection for High-Risk T1 to T2 Low Rectal Cancer: Results of a Single-Arm, Multi-Institutional, Phase II Clinical Trial. Dis Colon Rectum, 60:914-921, 2017

12. Yamaguchi T, Konishi T, Kinugasa Y, Yamamoto S, Akiyoshi T, Okamura R, Ito M, Nishimura Y, Shiozawa M, Yamaguchi S, Hida K, Sakai Y, Watanabe M. Laparoscopic Versus Open Lateral Lymph Node Dissection for Locally Advanced Low Rectal Cancer: A Subgroup Analysis of a Large Multicenter Cohort Study in Japan. Dis Colon Rectum, 60:954-964, 2017

13. Yamazaki N, Koga Y, Taniguchi H, Kojima M, Kanemitsu Y, Saito N, Matsumura Y. High expression of miR-181c as a predictive marker of recurrence in stage II colorectal cancer. Oncotarget, 8:6970-6983, 2017

14. Kawai T, Hayashi H, Nishizawa Y, Nishikawa A, Nakamura R, Kawahira H, Ito M, Nakamura T. Compact forceps manipulator with a spherical-coordinate linear and circular telescopic rail mechanism for endoscopic surgery. Int J Comput Assist Radiol Surg, 12:1345-1353, 2017

15. Hamabe A, Ito M. A three-dimensional pelvic model made with a three-dimensional printer: applications for laparoscopic surgery to treat rectal cancer. Tech Coloproctol, 21:383-387, 2017