大腸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 Ver.1
Contents
1.2. MRI 3 MRI MRI MR MR
3. 12 4 BTS 12 BTS 12 8 Web
4. 1 9
5. a Indication BTS Patients requiring palliative and bridge to surgery treatment of colorectal strictures produced by malignant neoplasms only patients with no previous colonic stenting will be included in the registry Contra Indication Patients contraindicated will include those presenting enteral ischemia SUSDected or impending perforation intrabdominal abscess perforation Strictures that do not allow passage of a guide wire patients for whom endoscopic techniques are contraindicated any use Other than those specifically Outlined under indications of use
6. A patient with a previous colonic stent implanted will not be eligible to be introduced into the registry data base The Colonic Stent will be used in accordance to the instructions for use 6 Web The agreement of the patient is necessary for all registration The registration institution registers all cases until the study finished Registration is carried out before the procedure or immediately after the procedure as soon as possible All registrations perform on Web site 7 e 12
7. 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 9
8. Single use only 4 200 2012 5 15 2013 12 31 5 200
9. 0 4 2 10 1 1 4 QOL RCT 4 van Hooft Lancet 2006 RCT 13 Hooft JE Lancet Oncol 2011 1 2 Perez J AJ Gastroenterol 2011 2 Saida Y Surg Endosc 2011
10. Ver 1 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 Ver1 10 10 12 13 UICC TNM 7 0 NMOS 690 N0 1
11. QOL 3 WallFlex WV Colonic Stent 2 0 035 3 7 mm 3
12. 100 200 200 12 BTS e e 24
13. Web site ID Password 10 NTT PC 3 25 Web
14. Web 113 8655 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
15. 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 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
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