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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009217
Receipt No. R000010825
Scientific Title Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Date of disclosure of the study information 2012/10/29
Last modified on 2012/10/29

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Basic information
Public title Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Acronym Photodynamic diagnosis of gastrointestinal cancer
Scientific Title Photodynamic diagnosis of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Scientific Title:Acronym Photodynamic diagnosis of gastrointestinal cancer
Region
Japan

Condition
Condition Gastrointestinal cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the value of the photodynamic diagnosis (PDD) of gastrointestinal cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) including safety and usefulness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results. The diagnostic capability of photodynamic diagnosis (PDD) using fluorescence (blue light) endoscopy was compared to that in conventional diagnostic method.
Key secondary outcomes Safety: The occurrence frequency and degree of adverse event were
investigated through the procedures.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment Maneuver
Interventions/Control_1 Two to two and half hours prior to endoscopy 1.5g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 8.4% sodium hydrogen carbonate (NaHCO3) solution was administrated orally (1.0g/50ml) or instilled intravesically (1.5g/50ml).
For fluorescence excitation a blue light source (D-LIGHT System, Karl Storz Endoscopy Japan K.K.) was used.
Under white and fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), tumor locations were recorded.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Patient who has primary and recurrent cancer of esophagus, stomach, colorectum, pancreas, liver, gallbladder and biliary tract.
Key exclusion criteria Patients who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Hanazaki
Organization Kochi Medical School
Division name Department of Surgery, Kochi Medical School
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Namikawa
Organization Kochi Medical School
Division name Department of Surgery, Kochi Medical School
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL +81-88-880-2370
Homepage URL http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
Email tsutomun@kochi-u.ac.jp

Sponsor
Institute Department of Surgery, Kochi Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ethical Review Boad of Kochi Medical School
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 高知大学医学部附属病院(高知県)
Kochi Medical School Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 29 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 30 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
2012 Year 10 Month 29 Day
Last modified on
2012 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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