UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049785 |
|---|---|
| Receipt number | R000055661 |
| Scientific Title | Living donor liver transplantation for non-resectable colorectal liver metastases |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2024/08/31 17:11:21 |
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Basic information
Public title
Living donor liver transplantation for non-resectable colorectal liver metastases
Acronym
Living donor liver transplantation for non-resectable colorectal liver metastases
Scientific Title
Living donor liver transplantation for non-resectable colorectal liver metastases
Scientific Title:Acronym
Living donor liver transplantation for non-resectable colorectal liver metastases
Region
| Japan |
Condition
Condition
non-resectable colorectal liver metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Efficacy and safety of living donor liver transplantation for non-resectable colorectal liver metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3 year Overall survival
Key secondary outcomes
1. Short-term (from living donor liver transplantation to discharge from hospital) outcomes of living donor liver transplantation.
Operative time, blood loss, perioperative complications (type, severity, treatment details, date of occurrence, and outcomes), and in-hospital mortality rates.
2. Short-term (within 90 days of living donor liver transplantation) results of living donor liver transplantation
Survival rate at 30 days and 90 days after transplantation.
3. Tumour recurrence rate, type of recurrence, and type of treatment for the recurrence tumour
4. Adverse events other than tumour recurrence after transplantation
5. Two- and three-year recurrence-free survival rates and graft survival rates after transplantation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
living donor liver transplantation
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A: criteria for the disease
1. Histological evidence of colorectal adenocarcinoma
2. Genetic examination for RAS, BRAFV600E, MSI, and mismatch repair gene
3. Primary colorectal cancer was curatively resected.
4. Liver metastases from colorectal cancer were diagnosed as surgically non-resectable, including those after repeated hepatectomies. Non-resectable cases are associated with the risk of PHLF owing to insufficient remnant liver volume or function.
Non-resectable means the following cases (i) and (ii),
(i) Cases in which there is concern of liver failure due to anatomical inability to secure sufficient volume in the remaining liver.
Cases in which the residual liver volume does not allow approximately 30% of the total liver volume after resection, or in which tumor invasion of the major vessels makes it difficult to maintain blood flow to the residual liver.
(ii) When there is concern about liver failure due to inadequate function of the residual liver caused by liver dysfunction.
When the K-ICG value of the residual liver is less than 0.05 in the ICG test.
5. Based on the imaging diagnosis, the metastatic lesion was only present in the liver. Diagnostic imaging modalities include contrast-enhanced computed tomography, magnetic resonance imaging, and fluorodeoxyglucose-positron emission tomography.
6. No history of distant metastases, except in the liver. However, patients with no more than three lung metastases without recurrence for more than six months after treatment are eligible as exceptions.
7. medical therapy was administered more than three months before enrolment.
8. Patients who are at least 18 years old and give written consent to this study.
B. Conventional criteria for LDLT
1. Age is >18, <70
2. PS 0 or 1
3. Main organ function is maintained as follows,
- Neut: > 1,500/uL
- Plt: > 30,000/uL
- Hb: > 7.5 g/dL
- Cre: <1.5 mg/dL
- NYHA class II or lower.
- Hugh-Jones class II or lower.
Key exclusion criteria
1. Diagnosed as progressive disease after medical therapy evaluated using RESIST version 1.1.
2. An infectious disease requiring treatment
3. Pregnancy
4. Psychiatric disorder or psychiatric symptoms that interfere with daily life and make it difficult to participate in the study
5. Other cases considered as not eligible for living-donor liver transplantation at each participating institution.
Target sample size
23
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
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city
TEL
075-751-3242
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Fukumitsu |
Organization
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto city
TEL
075-751-3242
Homepage URL
tsurugi@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
Konoe-cho, Yoshida, Sakyo-ku, Kyoto-city
Tel
075-753-4680
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
| 2023 | Year | 04 | 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
| 2022 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2032 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055661
