UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058662 |
|---|---|
| Receipt number | R000067082 |
| Scientific Title | The Third Nationwide Survey on Postoperative Complications and Outcomes of Living Liver Donors in Japan |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/08/07 14:44:39 |
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Basic information
Public title
The Third Nationwide Survey on Postoperative Complications and Outcomes of Living Liver Donors in Japan
Acronym
The Third Nationwide Survey of Living Liver Donors
Scientific Title
The Third Nationwide Survey on Postoperative Complications and Outcomes of Living Liver Donors in Japan
Scientific Title:Acronym
The Third Nationwide Survey of Living Liver Donors
Region
| Japan |
Condition
Condition
Living Liver Donor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the complication rate and outcomes of living liver donors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative incidents and postoperative complications
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Donors who provided living liver grafts at certified living donor liver transplantation centers in Japan between November 13, 1989, and December 31, 2024
Key exclusion criteria
1. Brain-dead donors
2. The first recipient in domino liver transplantation
3. Individuals deemed unsuitable as study subjects (participants) by the principal investigator
Target sample size
10700
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Soejima |
Organization
Shinshu University School of Medicine
Division name
Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery, Department of Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2654
ysoejima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Shimizu |
Organization
Department of Surgery, Shinshu University School of Medicine
Division name
Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2654
Homepage URL
ashimizu@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Life Science and Medicine, Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2025 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | 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
Participant background, sex, age, height, weight, preoperative comorbidities, graft type, intraoperative incidents, factors contributing to the incidents, management of the incidents, postoperative complications, timing of complication onset, factors contributing to the complications, management of the complications, postoperative hospital stay, presence or absence of sequelae, and outcomes.
Management information
Registered date
| 2025 | Year | 07 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067082
