UMIN ID: UMIN000053932
Registered date:15/04/2024
Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Benign biliary stricture |
| Date of first enrollment | 2024/04/15 |
| Target sample size | 74 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | polyurethane plastic stent group and polyurethane/PTFE plastic stent group stent deployment during 3 months |
Outcome(s)
| Primary Outcome | stent patency rate at 3 months |
|---|---|
| Secondary Outcome | Reason for stent dysfunction, endoscopic findings of removal stent, technical success rate, adverse event, primary disease, procedure time |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Total gastrectomy 2. combined with percutaneous transhepatic biliary drainage 3. Hilar stricture |
Related Information
| Primary Sponsor | Osaka Medical and Pharmaceutical University, |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Osaka Medical and Pharmaceutical University, |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Atsushi Okuda |
| Address | 2-7 Daigakuchou, Takatsukishi, Osaka Japan 569-8686 |
| Telephone | 072-683-1221 |
| ubuntu_koromo@yahoo.co.jp | |
| Affiliation | Osaka Medical and Pharmaceutical University 2nd Department of Internal Medicine |
| scientific contact | |
| Name | Takeshi Ogura |
| Address | 2-7 Daigakuchou, Takatsukishi, Osaka Japan |
| Telephone | 072-683-1221 |
| oguratakeshi0411@yahoo.co.jp | |
| Affiliation | Osaka Medical and Pharmaceutical University Hospital Endoscopy Center |