UMIN ID: UMIN000000943
Registered date:01/10/2008
Efficacy in Patients with Portal-Systemic Encephalopathy treated via Balloon-occluded Retrograde Transvernous Obliteration
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | The patients with portal-systemic encephalopathy, and presence of gastro-renal shunts(above 1cm in a diameter), as determined via contrast enhanced computed tomography (CT) |
| Date of first enrollment | 2003/01/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | B-RTO standard therapy(drug) |
Outcome(s)
| Primary Outcome | Neuropsychological Tests improvement of hepatic encephalopathy |
|---|---|
| Secondary Outcome | 1.Event(death,gastrointestinal bleeding,occurrence of HCC, and liver failure) 2.Child-Pugh score, and MELD 3.Serum laboratory values included the serum ammonia level 4.HQOL(SF-36) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.recent gastrointestinal bleeding 2.Child-Pugh classification C 3.serum creatinine level>2 mg/dl 4. HCC 5.splenectomy,PSE,TIPS, and Hassab operation 6.portal vein thrombosis |
Related Information
| Primary Sponsor | National Hospital Organization Iwakuni Clinical Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| chiken@iwakuni-nh.go.jp | |
| Affiliation | National Hospital Organization Iwakuni Clinical Center Clinical Research |
| scientific contact | |
| Name | Yoshitaka Takuma |
| Address | 2-5-1 Kuroiso-cho, Iwakuni ,Yamaguchi,Japan Japan |
| Telephone | |
| Affiliation | National Hospital Organization Iwakuni Clinical Center Department of Internal Medicine |