UMIN ID: UMIN000000542
Registered date:01/01/2007
Feasibility study of percutaneus endoscopic gastrostomy with Direct IDEAL PEG for patients with active head and neck cancer and esophageal cancer.
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | patients with active head and neck cancer and esophageal cancer |
| Date of first enrollment | 2006/12/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | PEG |
Outcome(s)
| Primary Outcome | completion rate of PEG |
|---|---|
| Secondary Outcome | Incidence of adverse event Incidence of severe adverse event |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. impossible of passage of endoscopy 2. exsisting of fistula 3. after gastrectomy 4. active infection 5. risk of GI bleeding 6. massive ascites 7. disapproval of withdraw of anti coaguration agent 8. addiction of steroids 9. severe heart disease and uncontrolled hypertention and diabete 10. terminal stage within 4 months prognosis 11. ineligible judged by doctor in charge |
Related Information
| Primary Sponsor | National Cancer Center Hospital East |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Olympus |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomonori Yano |
| Address | Japan |
| Telephone | |
| toyano@east.ncc.go.jp | |
| Affiliation | National Cancer Center Hospital East Division Digestive Endoscopy and GI Oncology |
| scientific contact | |
| Name | Manabu Muto |
| Address | 6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan Japan |
| Telephone | |
| Affiliation | National Cancer Center Hospital East Division Digestive Endoscopy and GI Oncology |