UMIN ID: UMIN000000784
Registered date:01/09/2007
Risk Factors and Therapies for Gastric Variceal Bleeding in Japan:prospective study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Patients with ruptured gastric fundal varices |
| Date of first enrollment | 2007/07/01 |
| Target sample size | 160 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Cumulative rebleeding rates in patients with ruptured gastric fundal varices |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Patients with advanced HCC who were unable to undergo curative treatment 2. Patients with a solitary HCC (more than 5cm in a diameter of the tumor) who received surgical treatment 3.Recurrent HCC 4.Portal vein thrombosis 5.Other malignancies without curative treatments 6.T.Bil > or =4mg/dl 7.Parmanent organ failure except for liver failure 8.Patients failed to hemostasis, or died within 24 hours from onset of bleeding 9. Patients received prior treatments of gastric varices (e.g., TIPS, surgery, PSE or splenectomy) 10.Patients whom judged to be inadequate by the doctor |
Related Information
| Primary Sponsor | National Hospital Organization Head quarter |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | National Hospital Organization Head quarter |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazuya Kimura |
| Address | Japan |
| Telephone | |
| Affiliation | National Hospital Organization Iwakuni Clinical Center Department of Clinical Research |
| scientific contact | |
| Name | Yasuhiro Makino |
| Address | 2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi , Japan Japan |
| Telephone | |
| Affiliation | National Hospital Organization Iwakuni Clinical Center Internal Medicine |