UMIN ID: C000000044
Registered date:06/08/2005
A phase II study of palliative treatment with metallic stents for inoperable malignant colorectal strictures. (JIVROSG-0206)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Inoperable malignant colorectal strictures. |
| Date of first enrollment | 2003/02/01 |
| Target sample size | 33 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A bare stent is placed in the stenotic portion of sigmoid colon or rectum caused by malignant tumor via the trans-anal route. |
Outcome(s)
| Primary Outcome | Improvement of subjective symptoms at 1 day, 1,2 and 4 weeks after stenting. |
|---|---|
| Secondary Outcome | Adverse events, improvement of abdominal radiography findings at 1 day, 1,2 and 4 weeks after stenting. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) The operation for colostomy scheduled. 2) Stenting as the preoperative preparation for the resection. 3) Serious bleeding from the lesion. 4) Pregnancy. |
Related Information
| Primary Sponsor | Japan Interventional Radiology in Oncology Study Group (JIVROSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuaki Arai |
| Address | 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan |
| Telephone | 03-3542-2511 |
| jivrosgoffice@ml.res.ncc.go.jp | |
| Affiliation | JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital |
| scientific contact | |
| Name | Yoshitaka Inaba |
| Address | 1-1, Kankoden, Chikusaku, Nagoya 464-8681, Japan Japan |
| Telephone | 052-762-6111 |
| Affiliation | Aichi Cancer Center Department of Diagnostic Radiology |