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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026868
Receipt No. R000030396
Scientific Title Photodynamic diagnosis of gastroentelogical carcinoma by using spectroscope
Date of disclosure of the study information 2017/04/06
Last modified on 2018/10/31

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Basic information
Public title Photodynamic diagnosis of gastroentelogical carcinoma by using spectroscope
Acronym Photodynamic diagnosis of gastroentelogical carcinoma
Scientific Title Photodynamic diagnosis of gastroentelogical carcinoma by using spectroscope
Scientific Title:Acronym Photodynamic diagnosis of gastroentelogical carcinoma
Region
Japan

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

Objectives
Narrative objectives1 The usability of the spectroscope for the lymph node metastasis of gastric and pancreatic cance by using 5-ALA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The accuracy of positive rate of the lymph node metastasis using the spectroscopy.
Key secondary outcomes We evaluate the lymph nodes, the main tumor and the other lesions suspected metastasis to the following items.
*The diagnosability by spectroscopy, fluorescent observation and white light observation.
*The relationship between histological type and spectrum.
*The relationship between tumor volume and spectrum.
*The appropriate cut off value of fluorescent intensity.
*The effectiveness of the spectroscope compared with VLD-EX(SBI Pharma).

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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 5-ALA is administrated 2-4 hours before operation orally.
We perform standard approach operation.
First, after removing the lymph nodes, we examine PDD with fluorescent observation.
Second, we randomly chose one of the lymph nodes which seems negative by the fluorescent observation.
And we diagnosis the metastasis using spectroscope which is developed through the collaborative research with Chitose Institute of Science and Technology.
We evaluate the accuracy of spectroscope based on the histopathological diagnosis.
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 Patients above 20 years old.
Patients have malignant tumor lesions in the stomach or pancreas.
Patients who provided signed informed consent.
Key exclusion criteria Patients with a history of hypersensitivity of 5-ALA or porphyrins
Porphyria
Patients taking drugs that may cause photosensitivity
Patients who is or might be pregnant
Patients who have liver dysfunction
Patients who have kidney dysfunction
Patients who have ischemic heart disease
Patients who are during lactation or hope becoming pregnant
Patients who is determined inappropriate to participate in the study by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirano
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery II
Zip code
Address North 15 West 7, Kita-Ku, Sapporo , Hokkaido, Japan
TEL 011-706-7714
Email satto@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuma Ebihara
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological Surgery II
Zip code
Address North 15 West 7, Kita-Ku, Sapporo , Hokkaido, Japan
TEL 011-706-7714
Homepage URL
Email yuma-ebi@wc4.so-net.ne.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Gastroenterological Surgery II
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 06 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
2017 Year 03 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 06 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
2017 Year 04 Month 05 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030396

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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