UMIN ID: UMIN000019622
Registered date:04/11/2015
Endoscopic closure of postsurgical esphageal fistula using polyglycolic acid sheets with fibrin glue
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | esophageal fistula due to esophagectomy for esophageal cancer |
| Date of first enrollment | 2015/11/04 |
| Target sample size | 5 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | polyglycolic acid (PGA) sheets with fibrin glue |
Outcome(s)
| Primary Outcome | rate of adverse event of the treatment |
|---|---|
| Secondary Outcome | Rate of closing fistula Number of the treatment for closing fistula Curative rate of fistula Days required curing fistula Days of admission from initial treatment |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patient without agreement 2. Patient with pregnancy or breast-feeding 3. Patient with mental illness 4. Patient with severe liver, heart, or renal disease 5. Patient with severe infection 6. Patient with severe bleeding or shock 7. Patient who have allergy for polyglycolic acid (PGA) sheets with fibrin glue 8. Patient who was assessed inadewuancy |
Related Information
| Primary Sponsor | Osaka City University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka City University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuaki Nagami |
| Address | 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3811 |
| yasuaki-75@med.osaka-cu.ac.jp | |
| Affiliation | Osaka City University Graduate School of Medicine Department of Gastroenterology |
| scientific contact | |
| Name | Yasuaki Nagami |
| Address | 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan Japan |
| Telephone | 06-6645-3811 |
| yasuaki-75@med.osaka-cu.ac.jp | |
| Affiliation | Osaka City University Graduate School of Medicine Department of Gastroenterology |