UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059506 |
|---|---|
| Receipt number | R000068026 |
| Scientific Title | A Prospective Observational Study on the Efficacy and Safety of Living Donor Liver Transplantation for Liver Metastases from Pancreatic and Gastrointestinal Neuroendocrine Tumors |
| Date of disclosure of the study information | 2025/10/25 |
| Last modified on | 2025/10/22 20:06:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Prospective Observational Study of Living Donor Liver Transplantation for Liver Metastases from Pancreatic and Gastrointestinal Neuroendocrine Tumors
Acronym
NET-LT
Scientific Title
A Prospective Observational Study on the Efficacy and Safety of Living Donor Liver Transplantation for Liver Metastases from Pancreatic and Gastrointestinal Neuroendocrine Tumors
Scientific Title:Acronym
NET-LT Study
Region
| Japan |
Condition
Condition
Liver metastases from pancreatic and gastrointestinal neuroendocrine tumors
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to establish a platform to evaluate the safety and efficacy of living donor liver transplantation for liver metastases from pancreatic and gastrointestinal neuroendocrine tumors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Survival
Key secondary outcomes
Disease-free survival, graft survival rate, postoperative complication rate, in-hospital mortality, and 90-day postoperative mortality
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Histologically confirmed pancreatic or gastrointestinal neuroendocrine tumor
2 Presence of synchronous or metachronous liver metastases that are deemed unresectable for one or more of the following reasons, Functionally unresectable, Technically unresectable, Oncologically unresectable
3 Absence of extrahepatic metastases confirmed by somatostatin receptor imaging.
4 Availability of an appropriate living donor candidate.
5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6 Adequate function of major organs
7 Age between 18 and 69 years
Key exclusion criteria
1. Histologically diagnosed neuroendocrine carcinoma or mixed neuroendocrine-non-neuroendocrine neoplasm.
2. Unknown primary site of the neuroendocrine tumor.
3. Presence of extrahepatic distant metastases.
4. Presence of active double cancers, concurrent malignancies requiring treatment.
5. Presence of active infections requiring treatment.
6. Pregnant or potentially pregnant women.
7. Presence of psychiatric disorders or symptoms that interfere with daily life and are considered to make participation in the study difficult.
8. Any other cases deemed ineligible for living donor liver transplantation under standard clinical practice.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757514323
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yamane |
Organization
Graduate School of Medicine and Faculty of Medicine Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
6068507
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
0757514323
Homepage URL
ykspirit@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
0753667618
ethcom@kuhp.kyoto-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 | 10 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068026
