UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013530 |
|---|---|
| Receipt number | R000015814 |
| Scientific Title | The impact of Dai-Ken-Chuto on the outcome of the patients in adult living donor liver transplantation. |
| Date of disclosure of the study information | 2014/03/27 |
| Last modified on | 2022/06/13 20:08:58 |
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Basic information
Public title
The impact of Dai-Ken-Chuto on the outcome of the patients in adult living donor liver transplantation.
Acronym
The impact of DKT in LDLT.
Scientific Title
The impact of Dai-Ken-Chuto on the outcome of the patients in adult living donor liver transplantation.
Scientific Title:Acronym
The impact of DKT in LDLT.
Region
| Japan |
Condition
Condition
The recipients of adult living donor live r transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of DKT, to reduce the abdominal distention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The volume of abdominal gas, which is evaluated with abdominal X-ray.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of DKT.
Interventions/Control_2
No administration of DKT.
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The adult patients who underwent living donor liver tranaplantation.
Key exclusion criteria
The patients who are not agrree to the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhisa Takatsuki |
Organization
Nagasaki Univ. Faculty of medicine
Division name
Department of Surgery
Zip code
Address
1-7-1Sakamoto, Nagasaki
TEL
0958197316
takapon@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhisa Takatsuki |
Organization
Nagasaki Univ.
Division name
Department of Surgery
Zip code
Address
1-7-1Sakamoto, Nagasaki
TEL
0958197316
Homepage URL
takapon@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki Univ. Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Nagasaki Univ.
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
| 2014 | Year | 03 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015814
