UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042980 |
|---|---|
| Receipt number | R000049026 |
| Scientific Title | Mixed hepatocellular carcinoma and cholangiocarcinoma in liver transplantation: Prognostic factors for outcomes in Korea-Japan multicenter study |
| Date of disclosure of the study information | 2021/01/20 |
| Last modified on | 2023/07/20 17:09:15 |
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Basic information
Public title
Mixed hepatocellular carcinoma and cholangiocarcinoma in liver transplantation: Prognostic factors for outcomes in Korea-Japan multicenter study
Acronym
Mixed hepatocellular carcinoma and cholangiocarcinoma in liver transplantation: Prognostic factors for outcomes in Korea-Japan multicenter study
Scientific Title
Mixed hepatocellular carcinoma and cholangiocarcinoma in liver transplantation: Prognostic factors for outcomes in Korea-Japan multicenter study
Scientific Title:Acronym
Mixed hepatocellular carcinoma and cholangiocarcinoma in liver transplantation: Prognostic factors for outcomes in Korea-Japan multicenter study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Mixed hepatocellular carcinoma and cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the risk factors for tumor recurrence and patient survival in patients with mixed HCC-CC after liver transplantation
Basic objectives2
Others
Basic objectives -Others
The clinicopathological characteristics and post-transplant prognosis of mixed HCC-CC have not previously been reported in detail because of its rarity. Considering the favorable outcomes reported for patients with 1 or 2 mixed HCC-CCs 2.0 cm or less, this suggests that patients in the very early stage of mixed HCC-CC may be candidates for LT. Additionally, given that very early mixed HCC-CC demonstrated favorable posttransplant prognosis, less strict follow-up is necessary.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Risk factors for tumor recurrence and patient survival
Key secondary outcomes
Prediction of patients with mixed HCC-CC after liver transplantation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically proven mixed HCC-CC after liver transplantation. Liver transplantation was performed between January 2000 and December 2018.
Key exclusion criteria
Pathologically proven HCC or intrahepatic CCC after liver transplantation.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Yasutsugu |
| Middle name | |
| Last name | Takada |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Hepato-Biliary-Pancreatic and Breast Surgery
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
089-960-5327
takaday@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoharu |
| Middle name | |
| Last name | Yoshizumi |
Organization
Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5466
Homepage URL
yoshizumi.tomoharu.717@m.kyushu-u.ac.jp
Sponsor or person
Institute
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
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
Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-6254
ijkseimei@jimu.kyushu-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
| 2021 | Year | 01 | Month | 20 | 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
18
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative recipient/donor data
Operative data
Pathological data
Follow-up data
Management information
Registered date
| 2021 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049026
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
