UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058625 |
|---|---|
| Receipt number | R000067037 |
| Scientific Title | Nationwide Survey on the Current Status of Ex Vivo Liver Resection in Japan |
| Date of disclosure of the study information | 2025/07/29 |
| Last modified on | 2025/07/29 03:32:59 |
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Basic information
Public title
A Nationwide Survey on the Current Status of Ex Vivo Liver Resection in Japan
Acronym
Survey on the Current Status of Ex Vivo Liver Resection
Scientific Title
Nationwide Survey on the Current Status of Ex Vivo Liver Resection in Japan
Scientific Title:Acronym
Survey on the Current Status of Ex Vivo Liver Resection
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the safety and efficacy of ex vivo liver resection by investigating current practices through a questionnaire survey of liver transplant centers in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication rate
Key secondary outcomes
Overall survival rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent extracorporeal liver resection at liver transplant centers in Japan during the study period.
2. No age restrictions were applied.
3. Both male and female patients were included; no gender-based exclusion criteria were applied.
4. No specific target disease was defined; all indications for extracorporeal liver resection were eligible.
5. All types of extracorporeal liver resection were included, regardless of the specific surgical technique used.
Key exclusion criteria
1. Patients who declined to participate in the study.
2. Patients who were considered inappropriate for inclusion by the principal investigator.
Target sample size
32
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
Asahi 3-1-1, Matsumoto
TEL
0263-37-2654
notake@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Notake |
Organization
Shinshu University School of Medicine
Division name
Division of Gastroenterological, Hepato-Biliary-Pancreatic, Transplantation and Pediatric Surgery
Zip code
390-8621
Address
Asahi 3-1-1, Matsumoto, 390-8621, Japan
TEL
0263-37-2654
Homepage URL
https://shinshu-surgery.jp/digestive/
notake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Hepato-Biliary-Pancreatic and Transplant Surgery, Kanazawa University
Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Asahikawa Medical University
Department of Pediatric Surgery, Kyushu University
Department of Surgery and Science, Kyushu University
Department of Transplantation and Gastroenterological Surgery, Nagasaki University
Department of Gastroenterological and Transplant Surgery, Hiroshima University
Department of Gastrointestinal and Oncological Surgery, Yokohama City University
Kashiwa Kosei General Hospital
Fukuyama City Hospital
Tokyo Medical University Hachioji Medical Center
Department of Hepato-Biliary-Pancreatic and Transplant Surgery, Kyoto University
Department of Gastroenterological Surgery, Akita University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Life Sciences and Medicine, Faculty of Medicine, Shinshu University
Address
Asahi 3-1-1, Matsumoto, 390-8621, Japan
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
金沢大学肝胆膵・移植外科
旭川医科大学外科学講座肝胆膵・移植外科学分野
九州大学小児外科
九州大学 消化器・総合外科
長崎大学 移植・消化器外科学
広島大学 消化器・移植外科学
横浜市立大学消化器・腫瘍外科
柏厚生総合病院
福山市民病院
東京医科大学八王子医療センター
京都大学肝胆膵・移植外科
秋田大学消化器外科学講座
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 29 | 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
| 2025 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
1. As a preliminary survey, we will first assess the eligibility of liver transplant centers in Japan to participate in this study. We will also obtain consent from those facilities to answer a questionnaire regarding the presence or absence of extracorporeal liver resection cases and the number of such cases performed between 1988 and May 2024.
2. In the secondary survey, case report forms (CRFs) will be distributed to facilities that reported having performed extracorporeal liver resection during the target period. Participating centers will complete the CRFs with anonymized case data and return them to Shinshu University.
3. Finally, all collected data will be analyzed and summarized by Shinshu University.
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067037
