UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Photodynamic diagnosis by using 5-aminolevulinic acid in pancreaticobiliary neoplasm
Title of the study (Brief title)	Diagnosis using 5-aminolevulinic acid in pancreaticobiliary neoplasm
Region	Japan

Condition
Condition	Pancreaticobiliary tumor
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the diagnostic ability of 5-aminolevulinic acid in pancreaticobiliary neoplasm
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy of 5-aminolevulinic acid in pancreaticobiliary neoplasm
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Interventions/Control_1	A single oral administration of 5-aminolevulinic acid (1g)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who have an abnormality of biliary tree and/or pancreas. 2. Patients who provide a written informed consent.
Key exclusion criteria	1. Patients with porphyria. 2. Patients with hypersensitivity to 5-aminolevulinic acid or porphyrins. 3. In cases of known or suspected pregnancy or woman who are breast-feeding. 4. Patients who doctors regard as inappropriate ones for the enrollment due to some reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	Tsukasa Ikeura
Organization	Kansai Medical University
Division name	The Third Department of Internal Medicine
Address	2-5-1, Shinmachi, Hirakata, Osaka, Japan
TEL	072-804-0101
Email	ikeurat@hirakata.kmu.ac.jp

Public contact
Name of contact person	Tsukasa Ikeura
Organization	Kansai Medical University
Division name	The Third Department of Internal Medicine
Address	2-5-1, Shimachi, Hirakata
TEL	072-804-0101
Homepage URL
Email	ikeurat@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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 03 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 04 Day
Last modified on	2016 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000013429