Niti-S 大腸用ステント多施設 共同前向き安全性観察研究 プロトコール
Contents
1. Web site ID Password 102. 50 3 Niti S XX Niti S
3. NTT PC 3 25 Web 2 10 4 5 TEL 03 5332 6644 11 Research contact person and Funding source 153 8515 2 17 6 Colonic Stent Safe Procedure Research Group 03 3468 1251 FAX 03 84
4. 200 20183 10 11 2015 10 10 5 200 a Indication BTS
5. Bridge to surgery BTS The objective of this registry is to compile chinical experience of use of the Niti S Rnteral Colonic Stent for the treatment of malignant colo rectal strictures It is not the goal to change the usual treatment practice of the investigator or the center Patients will be treated as per usual medical practices 2 2011 7 WallFlex Colonic Stent 2012
6. 9 9 0 4 2 10 1 1 4 QOL randomized clinical trial RCT 4 van Hooft Lancet 2006 RCT 13 Hooft JE Lancet Oncol 2011
7. Patients requiring palliative treatment of colorectal strictures produced by malignant neoplasms Only patients with no previous colonic stenting will be included in the registry b Contra Indication Patients contraindicated will include those presenting enteral ischemia suspected or impending perforation intrabdominal abscess perforation benign strictures patients for whom endoscopic techniques are contraindicated any use other than those specifically outlined under indications of use nclusion in case that patient does not consent about regnstration A patient with a previous colonic stent implanted will not be eligible to be introduced into the registry data base The Niti S Enteral Colon
8. 0 085 8 7 mm 4 X MRI 3 MRI Single use only 4
9. 50 UMIN000007953 WallFlex stent Niti S Enteral Colonic Uncovered Stent D type Moon CM Dis Colon Rectum 2010 Cheung DY Surg Oncol 2012 Tominaga KK Dis Colon Rectum 2012 Yoshida S Dig Endosc 2013 WallFlex Colonic Stent QOL
10. BTS e e e CROSS 24 1 9
11. 12 8 Web 200 12 e
12. Nic Tumor Deposit s satellites N2 4 N2a 4 6 N2b 7 MX MO M1 Mia 1 Mib 2 10
13. 69 8506 Name of lead principal investigator Yoshihisa Saida Organization Toho University Ohashi Medical Center Division name Department of Surgery Address 153 8515 2 17 6 Ohashi Meguro ku Tokyo Japan 12 Public contact Web 113 8655 7 3 1 03 3815 5411 EAX 03 3814 0021 13 UICC TNM 7 NX NO N1 1 3 Nia 1 Nib 2 3
14. Niti S Prospectnve Feasibility Study of D Weave Uncovered Stent for Colon Protocol Treatment of malignant colo rectal obstruction with Colonic Stent Palliation and Bridge to Surgery endoscopic treatment of malignant stricture in the colon and rectum 25 7 29 Ver 2 UMIN ID UMINO00011304 So Soc oO SSD Oo Ron 2 10 UICC TNM 7 1 Niti 8 Colonic Stent
15. ic Stent will be used in accordance to the instructions for use 6 Web 7 e 12 12 4 BTS 12 BTS
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