UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018896 |
|---|---|
| Receipt number | R000020993 |
| Scientific Title | Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins after oral administration of 5-aminolevulinic acid. |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2021/06/15 18:05:50 |
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Basic information
Public title
Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins after oral administration of 5-aminolevulinic acid.
Acronym
Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins.
Scientific Title
Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins after oral administration of 5-aminolevulinic acid.
Scientific Title:Acronym
Differentiation between benign and malignant pancreaticobiliary lesion by measuring the bile levels of porphyrins.
Region
| Japan |
Condition
Condition
Patients who have abnormality in the bile on CT and/or MRI.
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the bile levels of porphyrin after oral administration of 5-aminolevulinic acid are potential markers for differentiating between benign and malignant pancreaticobiliary lesions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The bile levels of porphyrin after oral administration of 5-aminolevulinic acid in pancreaticobiliary lesions.
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
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
Oral administration of 5-aminolevulinic acid (1g/body) 3 hours before the collection of bile via ENBD tube.
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. Patients 20 years of age and older who have an abnormality in the bile on CT and/or MRI and undergo endoscopic naso-billiary drainage.
2. Patients who provide a written informed consent.
Key exclusion criteria
1. Patients with porphyria.
2. Patients with hypersensitivity to 5-aminolevulinic acid or porphyries.
3. Pregnant women, women who is breast-feeding, and women suspected of being pregnant.
4. Patients who doctors regards as inappropriate ones for the enrollment due to some reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Ikeura |
Organization
Kansai Medical University
Division name
The Third Department of Internal Medicine
Zip code
Address
2-5-1, Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
ikeurat@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa Ikeura |
Organization
Kansai Medical University
Division name
The Third Department of Internal Medicine
Zip code
Address
2-5-1, Shinmachi, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
ikeurat@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
SBI Pharmaceuticals Co., Ltd.
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
| 2015 | Year | 09 | Month | 10 | 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
| 2015 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020993
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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