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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042011
Receipt No. 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

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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
Email 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
Email soyama@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047943

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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