UMIN-CTR Clinical Trial

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