UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017325 |
|---|---|
| Receipt number | R000020103 |
| Scientific Title | Evaluation of Liver Fibrosis in Patients with Chronic Liver Injury via Shear wave with Smart maps |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/04/29 13:10:24 |
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Basic information
Public title
Evaluation of Liver Fibrosis in Patients with Chronic Liver Injury via Shear wave with Smart maps
Acronym
SwSm Trial
Scientific Title
Evaluation of Liver Fibrosis in Patients with Chronic Liver Injury via Shear wave with Smart maps
Scientific Title:Acronym
SwSm Trial
Region
| Japan |
Condition
Condition
Chronic liver injury
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the evaluation of liver fibrosis in patients with chronic liver injury via Shear wave with Smart maps(SwSm).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of degree of the liver fibrosis with speed of the shear elastic wave by SwSm.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with chronic liver injury or liver cirrhosis were histologically diagnosed by liver biopsy or liver specimen of resected liver.
2.We do not ask whether etiology of chronic liver injury or liver cirrhosis.
3.Patients received document agreement with participation in this study.
Key exclusion criteria
1.A pregnant woman and the patients with the pregnant possibility or the patients nursing a baby.
2.Contraindication of liver biopsy or liver resection.
3.splenectomy or PSE.
4. Patients who judged inappropriate by researcher.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
Hiroshima City Hospital
Division name
Internal Medicine
Zip code
Address
7-33 Motomachi, Naka-ku, Hiroshima
TEL
082-221-2291
takuma@enjoy.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
Hiroshima City Hospital
Division name
Internal Medicine
Zip code
Address
7-33 Motomachi, Naka-ku, Hiroshima
TEL
082-221-2291
Homepage URL
takuma@enjoy.ne.jp
Sponsor or person
Institute
Hiroshima City Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima City Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Primary Endpoint
We examine the evaluation of liver fibrosis in patients with chronic liver injury via SwSm.
2.Secondary Endpoints
We examine the evaluation of liver fibrosis in patients with chronic liver injury via SwSm and serum non-invasive markers.
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2015 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020103
