UMIN ID: UMIN000056409
Registered date:10/12/2024
Clinical outcomes comparing wait-and-see and early intervention strategies for asymptomatic bile duct stones.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | asymptomatic bile duct stones |
| Date of first enrollment | 2024/12/14 |
| Target sample size | 1000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | the composite rate of adverse events |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Patients with previous history of biliary drainage. 2) Patients with previous endoscopic papillectomy. 3) Patients with previous biliary surgery. 4) Patients with history of cholangitis, cholecystitis, or liver abscess. 5) Patients with previous history of cholestasis. 6) Patients with biliary stricture. 7) Patients with hepatolithiasis. 8) Patients with surgically-altered anatomy (Billroth-II or Roux-en-Y reconstruction). 9) Patients who are undergoing surgical bile duct extraction with cholecystectomy. 10) Patients under 18 years old or with pregnancy. |
Related Information
| Primary Sponsor | Toyama University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nobuhiko Hayashi |
| Address | 2630 Sugiya, Toyama, Toyama, Japan Japan 930-0194 |
| Telephone | 076-434-7301 |
| hayashi@med.u-toyama.ac.jp | |
| Affiliation | University of Toyama Third Department of Internal Medicine |
| scientific contact | |
| Name | Ichiro Yasuda |
| Address | 2630 Sugiya, Toyama, Toyama, Japan Japan |
| Telephone | 076-434-7301 |
| yasudaic@med.u-toyama.ac.jp | |
| Affiliation | Toyama University Hospital Third Department of Internal Medicine |