UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025915 |
|---|---|
| Receipt number | R000029796 |
| Scientific Title | A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/09/24 18:48:31 |
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Basic information
Public title
A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma
Acronym
A novel fluorescence diagnostic method of cholangiocarcinoma using 5-aminolevulinic acid
Scientific Title
A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma
Scientific Title:Acronym
A novel fluorescence diagnostic method of cholangiocarcinoma using 5-aminolevulinic acid
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the diagnostic ability of evalating 5-ALA expression under direct cholangioscopy in cholangiocarcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy rate of diagnosis of cholangiocarcinoma by evalation of expression of protoporphyrinIX
Key secondary outcomes
1.Technical success rate
2.Comparison between normal light, NBI observation and fluorescence observation for evalation of mucosal cancerous extension
3.Rate of complication
4.Rate of drug-related adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Period of implementation: 3 days
Maximum observation period: 12 months
A single dose of 5-ALA (5-ALA 20 mg / kg dissolved in 200 ml of water; dosage approved as an intraoperative diagnostic for brain tumor)
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
1. Bile duct stenosis suspected of cholangiocarcinoma
2. Patients who obtained informed concent
3. 20 years of age or older
Key exclusion criteria
1. Cases in ECOG performance status 4
2. Cases with serious complications in other organs
3. Cases who have difficulty in endoscopic approach via the ampulla of Vater
4. Cases under 20 years of age
5. Cases who don't give informed consent 6. Cases with hypersensitivity porphyrin related substances or its previous history
7. Cases with porphyria
8. Pregnant women or cases who may be pregnant
9. Other cases that the research responsibility (share) person judged inappropriate as the research subject
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Departments of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Muro |
Organization
Okayama University Hospital
Division name
Depertment of Endoscopy
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7219
Homepage URL
shinm0416@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co.
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel
086-235-7218
shinm0416@yahoo.co.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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029796
