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Ver.2 - 大腸ステント安全手技研究会
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1. MRI 3 MRI MRI MR MR
2. BTS e 24
3. 10 NTT PC 3 25 Web 2 10 4 5 TEL 03 5332 6644 11 Research contact person and Funding SOUrCe
4. a Indication BTS 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 SUSDected or impending perforation intrab
5. Bridge to surgery BTS The objective of this registry is to compile clinical experience of use of the 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 Der usual medical practiceS 2 2011 7 2012 9
6. Single use only 4 200 5 200
7. 153 8515 2 17 6 Colonic Stent Safe Procedure Research Group 03 3468 1251 FAX 03 3469 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
8. QOL 3 WallFlex Colonic Stent 2 0 035 3 7 mm 3
9. Ver 2 Colonic Stent prospective feasibility Study Treatment of malignant colo rectal obstruction with Colonic Stent Palliation and Bridge to Surgery endoscopic treatment of malignant stricture in the colon and rectum 24 6 1 Ver 1 25 9 10 ver 2 CO RNN 9 0 UICC TNM 7 1
10. 7 3 1 03 3815 5411 FAX 03 3814 0021 13 UICC TNM 7 NX NO N1 1 3 Nia 1 Nib 2 3 Nic Tumor Deposits satelltes N2 4 N2a 4 6 N2b 7 MX MO M1 Mia 1 Mib 2
11. 1 9 Web site ID Password
12. 4 BTS 12 12 BTS 12 8 Web 100 200 200 12
13. 9 0 4 2 10 1 1 4 QOL RCT 4 van Hooft Lancet 2006 RCT 139 Hooft JE Lancet Oncol 2011 1 2 Perez J AJ Gastroenterol 2011 2 Saida Y Surg Endosc 2011
14. dominal abscess perforation strictures that do not allow passage of a guide wire Datients for whom endoscopic techniques are contraindicated any use Other than those specifically Outlined under indications of use inclusion A patient with a previous colonic stent implanted will not be eligible to be introduced into the registry data Dase The WallFlex Colonic Stent will be used in accordance to the instructions for use 6 Web 7 12 12
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