Annual Report 2022
Division of Surgical Technology
Masaaki Ito, Takahiro Kinoshita, Nobuyoshi Takeshita, Yasuyuki Yoshida
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 safety and efficacy through clinical trials.
The Team and What We Do
By cooperation with the Center of New Surgical and Endoscopic Development for Exploratory Technology (NEXT), we have started to promote surgical device development consisting of clinical need selection, prototype design, POC (Proof of Concept) establishment, validation, and clinical trials. In addition, we will create an innovative medical development roadmap by establishing a hub for surgical device development in the National Cancer Center Hospital East (NCCHE) and building up a clinical supportive team for early-phase surgical device development.
Research Activities
Cooperation with the NEXT
We have strengthened the system for surgical device development with the support of coordinators for surgical innovation, intellectual property experts and regulatory experts in cooperation with the NEXT. While focusing on the development of medical devices through joint research and development with academia, we have advanced the development of medical devices and the establishment of a clinical trial implementation system in collaboration with the NEXT.
Innovative surgical robotic system developed by NCC-certified venture company, Asahi Surgical Robotics
We are developing an innovative robotic surgical instrument in collaboration with Asahi Surgical Robotics Co., Ltd. (Formerly A-Traction Inc., established in August 2015, acquired by Asahi Intecc Co., Ltd. in July 2021), an NCC-certified venture company. This device is a robot that supports laparoscopic surgery like an assistant beside the surgeon. Non-clinical trials to obtain approval to manufacture and sell the product were conducted in 2022, and it received regulatory approval from the PMDA in February 2023.
Platform development for the system for clinical trial operations
As a specific clinical study on the surgical application of oxygen saturation imaging developed at our hospital, we have carried out a "pilot study on intestinal blood flow evaluation using oxygen saturation imaging", and we indicated the effectiveness of the method.
Activities to match needs and seeds
To create opportunities for medical device development by companies in Chiba Prefecture and Tokyo, we have organized the event "Medical Needs and Engineering Seeds Matching Meeting in Oncology Field" with the National Cancer Center Hospital (NCCH) and Cancer Institute Hospital in Japanese Foundation for Cancer Research (JFCR) in cooperation with Chiba Prefecture, Tokyo and Tokyo Medical-Engineering collaboration HUB.
Development of medical devices using new biodegradable polymers
Together with radiologists from the NCCHE and the NCCH, we started joint research on radiofrequency ablation, cryosurgery, and spacers used in radiation therapy. It was awarded the Kyoto University Seeds for Interdisciplinary Research (Seeds H).
Clinical Trials
We conducted a pilot study as part of the research on intestinal blood flow evaluation using oxygen saturation imaging.
Education
We held regular in-house seminars to teach surgical device innovation for the development of human resources.
Future Prospects
We aim to establish a clinical support team for early-phase surgical device innovation and to develop a roadmap for surgical device innovation.
List of papers published in 2022
Journal
1. Yoshioka T, Hasegawa H, Ikeda K, Teramura K, Tsukada Y, Nishizawa Y, Ito M. Efficacy of transperineal minimally invasive surgery with laparoscopic abdominoperineal excision for lower rectal cancer. Surgery today, 53:490-498, 2023
2. Takeshita N, Sakamoto S, Kitaguchi D, Takeshita N, Yajima S, Koike T, Ishikawa Y, Matsuzaki H, Mori K, Masuda H, Ichikawa T, Ito M. Deep Learning-Based Seminal Vesicle and Vas Deferens Recognition in the Posterior Approach of Robot-Assisted Radical Prostatectomy. Urology, 173:98-103, 2023
3. Kitaguchi D, Hasegawa H, Teramura K, Ikeda K, Tsukada Y, Nishizawa Y, Ito M. Comparison of postoperative anorectal function between hand-sewn and stapled anastomoses in intersphincteric resection with transanal total mesorectal excision. The British journal of surgery, 110:375-376, 2023
4. Kitaguchi D, Wakabayashi M, Hasegawa H, Ando K, Ikeda K, Tsukada Y, Nishizawa Y, Ito M. Single-stapling technique versus hand-sewn anastomosis in inter-sphincteric resection with transanal total mesorectal excision (Super SST): protocol for a multicentre randomized clinical trial. BJS open, 7:zrac160, 2023
5. Kitaguchi D, Teramura K, Matsuzaki H, Hasegawa H, Takeshita N, Ito M. Automatic purse-string suture skill assessment in transanal total mesorectal excision using deep learning-based video analysis. BJS open, 7:zrac176, 2023
6. Kitaguchi D, Watanabe Y, Madani A, Hashimoto DA, Meireles OR, Takeshita N, Mori K, Ito M. Artificial Intelligence for Computer Vision in Surgery: A Call for Developing Reporting Guidelines. Annals of surgery, 275:e609-e611, 2022
7. Igaki T, Kitaguchi D, Kojima S, Hasegawa H, Takeshita N, Mori K, Kinugasa Y, Ito M. Artificial Intelligence-Based Total Mesorectal Excision Plane Navigation in Laparoscopic Colorectal Surgery. Diseases of the colon and rectum, 65:e329-e333, 2022
8. Hasegawa H, Tsukada Y, Wakabayashi M, Nomura S, Sasaki T, Nishizawa Y, Ikeda K, Takeshita N, Teramura K, Ito M. Impact of near-infrared fluorescence imaging with indocyanine green on structural sequelae of anastomotic leakage after laparoscopic intersphincteric resection of malignant rectal tumors. Techniques in coloproctology, 26:561-570, 2022
9. Kitaguchi D, Takeshita N, Matsuzaki H, Igaki T, Hasegawa H, Kojima S, Mori K, Ito M. Real-time vascular anatomical image navigation for laparoscopic surgery: experimental study. Surgical endoscopy, 36:6105-6112, 2022
10. Kitaguchi D, Fujino T, Takeshita N, Hasegawa H, Mori K, Ito M. Limited generalizability of single deep neural network for surgical instrument segmentation in different surgical environments. Scientific reports, 12:12575, 2022
11. Kitaguchi D, Lee Y, Hayashi K, Nakajima K, Kojima S, Hasegawa H, Takeshita N, Mori K, Ito M. Development and Validation of a Model for Laparoscopic Colorectal Surgical Instrument Recognition Using Convolutional Neural Network-Based Instance Segmentation and Videos of Laparoscopic Procedures. JAMA network open, 5:e2226265, 2022
12. Sasaki S, Kitaguchi D, Takenaka S, Nakajima K, Sasaki K, Ogane T, Takeshita N, Gotohda N, Ito M. Machine learning-based Automatic Evaluation of Tissue Handling Skills in Laparoscopic Colorectal Surgery: A Retrospective Experimental Study. Annals of surgery, 2022