UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042011 |
|---|---|
| Receipt number | R000047943 |
| Scientific Title | Analysis of the efficacy of surgical microscope vs. surgical loupe for biliary reconstruction in living liver transplantation -Multicenter randomized controlled trial - |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/04/10 08:52:30 |
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Basic information
Public title
Analysis of the efficacy of surgical microscope vs. surgical loupe for biliary reconstruction in living liver transplantation - Multicenter randomized controlled trial-
Acronym
The efficacy of surgical microscope vs. surgical loupe for biliary reconstruction in living liver transplantation
Scientific Title
Analysis of the efficacy of surgical microscope vs. surgical loupe for biliary reconstruction in living liver transplantation -Multicenter randomized controlled trial -
Scientific Title:Acronym
MRCT
Analysis of the efficacy of surgical microscope vs. surgical loupe for biliary reconstruction in living liver transplantation
Region
| Japan |
Condition
Condition
End-stage liver disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of biliary reconstruction with a surgical microscope in living-donor liver transplantation in a multicenter randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biliary complications (biliary stenosis or bile leak) within 52 weeks after transplantation
Key secondary outcomes
Duration of biliary reconstruction under microscope
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 considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Biliary reconstruction with a surgical microscope
Interventions/Control_2
Biliary reconstruction without a surgical microscope
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
Recipients undergoing duct-to-duct biliary anastomosis in living donor liver transplantation.
Key exclusion criteria
1. Recipients who require multiple biliary reconstructions
2. Not willing to participate in the project
Target sample size
158
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | Akihiko |
| Last name | Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Surgery
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki
TEL
0958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | Akihiko |
| Last name | Soyama |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of surgery
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki
TEL
0958197316
Homepage URL
soyama@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
Sakamoto 1-7-1, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2020 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047943
