UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001315 |
|---|---|
| Receipt number | R000001457 |
| Scientific Title | Transient elastography for transplanted liver in peritransplantation period. |
| Date of disclosure of the study information | 2008/08/16 |
| Last modified on | 2010/02/15 13:39:30 |
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Basic information
Public title
Transient elastography for transplanted liver in peritransplantation period.
Acronym
LT-Fibro study
Scientific Title
Transient elastography for transplanted liver in peritransplantation period.
Scientific Title:Acronym
LT-Fibro study
Region
| Japan |
Condition
Condition
posttransplant liver graft
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of transient elastography to recipients in early postoperative state and to document the dynamic change in the stiffness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-course change of the stiffness of the graft liver
Key secondary outcomes
The intraoperative blood flow of the liver graft.
Prevalence of postoperative complications
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
| Not applicable |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recipients planned to undego the liver transplantaion using the right liver graft in Tokyo university hospital and their corresponding donors.
Key exclusion criteria
1)The patients who has difficulty in undergoing postoperative transient elastography due to their physical frame, distortion of the graft liver, and dislocation of the graft in the abdomen.
2)The patients with severe postoperative complication or poor general status which makes it to difficult to endure the transient elastography.
3)The patients with other specific reason by which a physician determined to avoid or discontinue the transient elastography.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kokudo Norihiro |
Organization
University of Tokyo, Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo, Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Depar
Zip code
Address
TEL
Homepage URL
sukeyaubj@yahoo.co.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Department of Surgery
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 08 | Month | 01 | Day |
Other
Other related information
The success rate (valid shots/total shots) of all the LSM was 0.929 +- 0.119, featuring significant relationship with the thickness of the thoracic belt (p<0.0021). The interquartile range to median value rate of LSMs persisted rather high even one month after the transplantation compared to the preoperative values. Among LDLT recipients (n=24), the LSM value was highest in the first postoperative week, and declined thereafter. Recipients with complications had significantly higher LSM value than those without during study period
Management information
Registered date
| 2008 | Year | 08 | Month | 15 | Day |
Last modified on
| 2010 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001457
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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