UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037368 |
|---|---|
| Receipt number | R000042605 |
| Scientific Title | Development of surgical treatment for liver tumor using intraoperative MRI |
| Date of disclosure of the study information | 2019/07/15 |
| Last modified on | 2025/01/23 17:36:58 |
* 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
Development of surgical treatment for liver tumor using intraoperative MRI
Acronym
Development of surgical treatment for liver tumor using intraoperative MRI
Scientific Title
Development of surgical treatment for liver tumor using intraoperative MRI
Scientific Title:Acronym
Development of surgical treatment for liver tumor using intraoperative MRI
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of liver resection using intraoperative MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete tumor resection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
intraoperative MRI
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
Patients who meet all of the requirements described bellow are included.
1. Patients who undergo liver resection with intraoperative MRI.
2. Patients who provide a wittern informed consent.
Key exclusion criteria
Patients who meet any of the conditions described bellow are excluded.
1. Patients who can not undertake MRI.
2. Patients who are judged inappropriate by the doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ohdan |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5220
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5220
Homepage URL
tsukoba@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-5907
iryo-seisaku@office.hiroshima-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
| 2019 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC11213349/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11213349/
Number of participants that the trial has enrolled
23
Results
The complete resection rate for the tumor was 100%.
There were no adverse events related to intraoperative MRI.
Results date posted
| 2025 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the patients was 75 (range, 60-87) years, and 20 (87.0%) were males. among these patients, 11 (47.8%) were positive for hepatitis c virus antibody, 4 (17.3%) were positive for hepatitis b surface antigen, and 7 (30.4%) had cirrhosis. twenty-two (95.6%) and 15 (65.2%) patients had child-pugh grade a disease and a surgical history of hepatectomy, respectively. the median number of liver tumors was 2 (range, 1-4) The median size of the 25 target lesions was 9 (range, 5-15) mm.
Participant flow
During the study period from July 2019 to January 2022, 23 patients underwent intraoperative MRI-guided hepatectomy for 25 liver tumors measuring <20 mm, which were preoperatively identified using MRI and other modalities excluding US.
Adverse events
There were no adverse events related to the intraoperative MRI.
Outcome measures
The primary endpoint was the rate of complete tumor resection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 10 | 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
Management information
Registered date
| 2019 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042605
