UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054769 |
|---|---|
| Receipt number | R000062582 |
| Scientific Title | Study for building navigation for partial hepatectomy for liver tumors. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2025/01/21 11:04:48 |
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Basic information
Public title
Study for building navigation for partial hepatectomy for liver tumors.
Acronym
Study for building navigation for partial hepatectomy for liver tumors.
Scientific Title
Study for building navigation for partial hepatectomy for liver tumors.
Scientific Title:Acronym
Study for building navigation for partial hepatectomy for liver tumors.
Region
| Japan |
Condition
Condition
liver tumors
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In partial hepatectomy, marking just above the tumor, so that the point directly above the tumor determined using preoperative imaging can be confirmed during intraoperative manipulation, is useful for accurate tumor resection and can be performed safely.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Observation of the positional relationship between the fluorescently stained marking points and the tumor by ICG.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After induction of general anesthesia, percutaneous local injection of a mixture of 0.5 ml ICG and 0.5 ml anhydrous ethanol into a pre-determined point directly above the tumor using a CT-linked US navigation system before performing the procedure.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. preoperative imaging diagnosis of liver tumor and planned partial hepatectomy any histological type of biopsy tissue
2. Any histological type of biopsy tissue.
3. 18 years of age or older at the time of enrollment. No upper age limit is imposed. 4.
4. The subject must have received a written explanation of the study and must have given written consent.
Key exclusion criteria
1. pregnant women, those with a history of drug (iodine, ICG, ethanol) allergy, asthma, or hypersensitivity
2. those whose attending physician determines that participation in this study is inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Abe |
Organization
Keio University, School of Medicine
Division name
Department of Surgery (General and Gastroenterology)
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
yutaabe@keio.jp
Public contact
Name of contact person
| 1st name | Motonori |
| Middle name | |
| Last name | Edanami |
Organization
Keio University School of Medicine
Division name
Department of Surgery (General and Gastroenterology)
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
Homepage URL
edanami.keiomed@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2024 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062582
