UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051662 |
|---|---|
| Receipt number | R000058954 |
| Scientific Title | Randomized, parallel-group trial comparing water-jet with CUSA for parenchymal dissection in living-donor liver procurement |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2023/07/20 12:41:06 |
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Basic information
Public title
Analysis of the efficacy of water-jet method for parenchymal dissection in living-donor liver procurement - Randomized controlled trial -
Acronym
Analysis of the efficacy of water-jet method for parenchymal dissection in living-donor liver procurement
Scientific Title
Randomized, parallel-group trial comparing water-jet with CUSA for parenchymal dissection in living-donor liver procurement
Scientific Title:Acronym
Randomized trial comparing water-jet with CUSA for parenchymal dissection in living-donor liver procurement
Region
| Japan |
Condition
Condition
healthy living-donor for liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of WATER JET method for parenchymal dissection comparing with CUSA method in living-donor liver procurement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Speed of hepatic parenchymal dissection
Key secondary outcomes
Time of hepatic parenchymal dissection, intraoperative blood loss, rate of postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hepatic parenchymal dissection using water jet method in living-donor liver procurement
Interventions/Control_2
Hepatic parenchymal dissection using CUSA method in living-donor liver procurement
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Living-donor for liver transplantation
Key exclusion criteria
1. Living-donors who have anatomical anormarly in hepatic vessels by preoperative radiological assessment
2. Not willing to participate in the study
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Tomoharu |
| Middle name | |
| Last name | Yoshizumi |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5466
yoshizumi.tomoharu.717@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Toshima |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5466
Homepage URL
https://surg2.kyushu-u.ac.jp
toshima.takeo.962@m.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Boards / Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka city
Tel
092-641-1151
byskenkyu@jimu.kyushu-u.ac.jp
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
| 2023 | Year | 07 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058954
| 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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| Registered date | File name |
