UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011136 |
|---|---|
| Receipt number | R000010927 |
| Scientific Title | The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant liver tumor |
| Date of disclosure of the study information | 2013/07/06 |
| Last modified on | 2014/01/06 10:50:20 |
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Basic information
Public title
The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant liver tumor
Acronym
Five-aminolevulinic acid for fluorescence-guided resection of malignant liver tumor
Scientific Title
The study of fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant liver tumor
Scientific Title:Acronym
Five-aminolevulinic acid for fluorescence-guided resection of malignant liver tumor
Region
| Japan |
Condition
Condition
malignant liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study assess the feasibility of intraoperative 5-aminolevulinic acid (5-ALA) fluorescence guidance for resection of malignant liver tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resection rate
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
5ALA oral intake
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
Patients who meet all of the requirements described below are included.
1.Patients who are hospitalized at Kansai Medical university Hirakata hospital in order to undergo surgery.
2.Patients who are diagnosed with malignant liver tumor.
3.Patients who provide a written informed consent.
Key exclusion criteria
Patients who meet any of the conditions described below are excluded.
1.Patients with porphyria.
2.Patients with hypersensitivity to 5-ALA or porphyrins.
3.In cases of known or suspected pregnancy or woman who are breast-feeding.
4.In cases of hepatic insufficiency (total bilirubin >2.4mg/dL, AST>70U/L, ALT>70U/L) on post 1 and 7 days after taking 5-ALA before 2 weeks of surgery.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University Hirakata Hospital
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi Hirakata city, Osaka
TEL
072-804-0101
kaibori@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Matsui |
Organization
Kansai Medical University Hirakata Hospital
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi Hirakata city, Osaka
TEL
072-804-0101
Homepage URL
matsuik@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Surgery, Hirakata Hospital, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kansai Medical University
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
Address
Tel
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
関西医科大学付属枚方病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 06 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | 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
| 2013 | Year | 07 | Month | 06 | Day |
Last modified on
| 2014 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010927
