UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026868 |
|---|---|
| Receipt number | R000030396 |
| Scientific Title | Photodynamic diagnosis of gastroentelogical carcinoma by using spectroscope |
| Date of disclosure of the study information | 2017/04/06 |
| Last modified on | 2021/12/01 12:30:54 |
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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
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
yuma-ebi@wc4.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Gastroenterological Surgery II
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
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
| 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030396
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