The Japan Colonic Stent Safe Procedure Research Group, Representative Chair,
Hiroyuki Isayama, MD., PhD., Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Message from the Representative Chair
My name is Hiroyuki Isayama, and it is a great honor for me to have been appointed as the Representative Chair of the Japan Colonic Stent Safe Procedure Research Group (JCSSPRG).
First and foremost, I would like to express my deepest gratitude to a former representative chair of JCSSPRG, Professor Yoshihisa Saida, who has led this study group with remarkable dedication and vision for many years. Long before colorectal stent therapy became widely recognized, Professor Saida devoted himself to establishing safe procedural techniques, clarifying appropriate indications, developing educational frameworks, and building a strong nationwide network of colleagues. Numerous high-quality publications originating from this study group have contributed not only to clinical practice in Japan but also to international guidelines, including those in Europe. The foundation and passion he has built represent the greatest asset of this study group, and his contributions to improving the quality of colorectal stent therapy throughout Japan are truly immeasurable.
Building firmly upon the legacy established by Professor Saida, our study group will continue to promote the safe and reliable use of colorectal stent therapy through evidence-based discussions, shared strategies for complication prevention, education of younger physicians, and strengthened international collaboration.
At present, our group is conducting clinical trials focusing on the efficacy of covered self-expandable metallic stents and the safety of colorectal stenting in the setting of chemotherapy. Moving forward, we aim to work together to identify and address unmet needs encountered in various clinical scenarios, thereby further refining and advancing safe and effective colorectal stent therapy. In recent years, including the introduction of Japan’s first domestically developed stents, several innovative devices have entered the market, creating great momentum in this field. We hope to advance these efforts in close collaboration with our industry partners and to disseminate the highest level of quality in colorectal stent therapy to the world. The support and cooperation of industry colleagues are essential, and I sincerely appreciate their continued partnership.
Together with all of you, I look forward to further advancing colorectal stent therapy in Japan and delivering the best possible care to our patients. I respectfully ask for your continued support and guidance as we move forward.
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(1) Research Group Background and Objectives
Because metal stents have not obtained pharmaceutical approval and are not yet covered by Japan’s National Health Insurance system for the treatment of colonic stenosis, clinical research is conducted at a limited number of institutions, the stents are misappropriated for use as esophageal stents, and procedures are conducted with the use of colonic stents that are individually imported from overseas. A US-manufactured colonic stent finally received pharmaceutical approval in July 2011, and after approval for insurance coverage, the stent became available for use on a national level in 2012. Research was then conducted retrospectively to confirm safety of the device after discussions regarding safe procedures, and the purpose of this Research Group is to provide instruction regarding national safety procedures for placement of colonic stents.
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(2) The Need for a Research Group
Consensus and awareness programs are now necessary so that safe colonic stenting procedures can be identified and promoted throughout Japan. In general, standard procedures for placement of colonic stents remain to be established; the procedural steps and precautions presently practiced for placement of biliary tract stents, for example, cannot be relied upon for placement of stents in the gastrointestinal tract. The Colonic Stent Safe Procedure Research Group was founded to facilitate informed discussions of these very important considerations with all relevant parties. During a European randomized controlled clinical trial that compared emergency surgery with bridge-to-surgery placement of a colonic stent to treat ileus caused by colon cancer, the incidence of perforation in the stent group was high (13%), therefore the study was discontinued (Hooft JE, Lancet Oncol 2011). Doubts arose regarding stent efficacy. However, according to a similar multinational, multicenter study conducted retrospectively in the US, when stent placement was done after sufficient investigation of a safe placement method, the incidence of perforation was exceptionally low at 1.2%, and the procedure was acknowledged as being safe (Perez J, Am J Gastroenterol 2011). A concurrent report from within Japan also documented a low perforation rate (2%) and affirmed that complications are uncommon (Saida Y, Surg Endosc 2011). Even under these circumstances, we believe that this research group is indispensable for safe introduction of colonic stenting in Japan.
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(3) Expected Outcomes: Planned Clinical Research
1) The Research Group will identify safe, practical methods and necessary precautions for the placement of colonic stents that are based on the findings of international research groups and the aggregate outcomes observed in Japan to date, through discussion with institutions that have experience with colonic stents, and through discussion with institutions that have sufficient experience with each type of endoscopic procedure. The Research Group will compile and then condense the information into a set of mini-guidelines that will be published on the Toho University Ohashi Medical Center website. In addition, a translated version of this information will be available for global access.2) Patients who will undergo placement of a commercially available colonic stent that is covered by the National Health Insurance will be prospectively enrolled in a study, and the data obtained will be aggregated and analyzed. Prospective feasibility studies for use of commercially available stents will be conducted. Enrollment for study of WallFlexTM and study of Niti-S has been completed. Going forward, the data collection and analysis will continue, and reports will be published first by the academic societies and then by the Research Group. 3) The Research Group will communicate information and conduct multicenter joint research with the goal of ensuring that patients have a positive clinical experience through the safe placement of colonic stents. 4) Through periodic meetings the Research Group will aim to provide joint ownership of the awareness campaign and information regarding safe procedures. UMIN ID：A02265 |
- Nov.19 2021
- The site has been renewed.