UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013181 |
|---|---|
| Receipt number | R000015358 |
| Scientific Title | Fluorescence detection of malignant liver tumors using 5-aminolevulinic acid-mediated photodynamic diagnosis |
| Date of disclosure of the study information | 2014/02/17 |
| Last modified on | 2014/02/17 21:05:07 |
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Basic information
Public title
Fluorescence detection of malignant liver tumors using 5-aminolevulinic acid-mediated photodynamic diagnosis
Acronym
Fluorescence detection using 5-ALA
Scientific Title
Fluorescence detection of malignant liver tumors using 5-aminolevulinic acid-mediated photodynamic diagnosis
Scientific Title:Acronym
Fluorescence detection using 5-ALA
Region
| Japan |
Condition
Condition
malignant tumors
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
a novel resection method using 5-ALA-mediated PDD as a primary treatment to completely remove malignant tumors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection of malignant tumor using 5-ALA fluorescent imaging
Key secondary outcomes
The detection of intra-operative bile leakage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Administration of 5-aminolevulinic acid
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
| 1 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with malignant tumors
Key exclusion criteria
the patient with porphilia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College Hospital
Division name
Departments of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka 569-8686, Japan
TEL
072-683-1221
uchi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Inoue |
Organization
Osaka Medical College Hospital
Division name
Departments of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
sur129@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of General and Gastroenterological Surgery,
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General and Gastroenterological Surgery,
Osaka Medical College Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 17 | 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
| 2013 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 17 | Day |
Last modified on
| 2014 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015358
| 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 |
