UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018275 |
|---|---|
| Receipt number | R000021150 |
| Scientific Title | Photodynamic therapy for bile duct carcinoma: Phase I / Phase II clinical trial. |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2016/02/12 10:17:59 |
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Basic information
Public title
Photodynamic therapy for bile duct carcinoma: Phase I / Phase II clinical trial.
Acronym
Photodynamic therapy for bile duct carcinoma: Phase I / Phase II clinical trial.
Scientific Title
Photodynamic therapy for bile duct carcinoma: Phase I / Phase II clinical trial.
Scientific Title:Acronym
Photodynamic therapy for bile duct carcinoma: Phase I / Phase II clinical trial.
Region
| Japan |
Condition
Condition
Bile duct carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of the treatment result of the cholangiocarcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood and urinary porphyrin density
Biochemical examination of blood
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
| Medicine | Device,equipment |
Interventions/Control_1
Laserphyrin 100 mg for injection; Porfimer sodium was intravenously injected at a dose of 2mg/kg body weight. An eximer dye pulsed laser with a wavelength of 630m Talaporfin sodium was intravenously injected at a dose of 40 mg/m2 4-6 hours prior to laser treatment and the laser apparatus used was a PDT semiconductor laser with a wavelength 50-100J/cm2
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
Cholangiocarcinoma
Key exclusion criteria
Non
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nanashima |
Organization
University of Miyazaki
Faculty of Medicine
Division name
Department of Surgery Division of Hepato- Biliary -Pancreatic Surgery
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692 JAPAN
TEL
+81-985-85-2905
a_nanashima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nanashima |
Organization
University of Miyazaki Faculty of Medicine
Division name
Department of Surgery Division of Hepato- Biliary -Pancreatic Surgery
Zip code
Address
5200 Kihara, Kiyotake, Miyazaki 889-1692 JAPAN
TEL
+81-985-85-2905
Homepage URL
a_nanashima@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University Hospital
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
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 | 08 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 11 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021150
| 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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