UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001315
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email sukeyaubj@yahoo.co.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Department of Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.