UMIN ID: UMIN000055977
Registered date:29/10/2024
A prospective study of metal stent placement for unresectable malignant distal biliary obstruction
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | unresectable distal biliary obstruction due to pancreatobiliary cancer |
| Date of first enrollment | 2024/11/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | time to recurrent biliary obstruction |
|---|---|
| Secondary Outcome | Causes of recurrence of biliary obstruction (RBO) Technical success rate Clinical success rate Rate of early adverse events Rate of late adverse events other than RBO Survival period Technical success rate of reintervention in cases of RBO |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with postoperative reconstruction of the upper gastrointestinal tract 2) Patients after bilioenteric anastomosis 3) Patients in whom clinical success is not expected by stent placement 4) Patients with a history of biliary drainage using metal stent 5) Pregnant patients 6) Patients who ultimately underwent surgical resection for the malignant distal biliary obstruction |
Related Information
| Primary Sponsor | Ise Red Cross Hospital |
|---|---|
| Secondary Sponsor | Shizuoka General Hospital Shizuoka, Yokkaichi Municipal Hospital, Suzuka General Hospital, Mie Chuo Medical Center |
| Source(s) of Monetary Support | None. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Toji Murabayashi |
| Address | 1-471-2, Funae, Ise, Mie, 516-8512, Japan Japan 516-8512 |
| Telephone | 0596-28-2171 |
| t-murabayashi@ise.jrc.or.jp | |
| Affiliation | Ise Red Cross Hospital Department of Gastroenterology |
| scientific contact | |
| Name | Toji Murabayashi |
| Address | 1-471-2, Funae, Ise, Mie, 516-8512, Japan Japan |
| Telephone | 0596-28-2171 |
| t-murabayashi@ise.jrc.or.jp | |
| Affiliation | Ise Red Cross Hospital Department of Gastroenterology |