UMIN-CTR Clinical Trial

Basic information
Public title	A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma
Acronym	A novel fluorescence diagnostic method of cholangiocarcinoma using 5-aminolevulinic acid
Scientific Title	A single-center, prospective pilot study to elucidate the fluorescence diagnostic ability of 5-aminolevulinic acid for cholangiocarcinoma
Scientific Title:Acronym	A novel fluorescence diagnostic method of cholangiocarcinoma using 5-aminolevulinic acid
Region	Japan

Condition
Condition	cholangiocarcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the diagnostic ability of evalating 5-ALA expression under direct cholangioscopy in cholangiocarcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy rate of diagnosis of cholangiocarcinoma by evalation of expression of protoporphyrinIX
Key secondary outcomes	1.Technical success rate 2.Comparison between normal light, NBI observation and fluorescence observation for evalation of mucosal cancerous extension 3.Rate of complication 4.Rate of drug-related adverse event

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Period of implementation: 3 days Maximum observation period: 12 months A single dose of 5-ALA (5-ALA 20 mg / kg dissolved in 200 ml of water; dosage approved as an intraoperative diagnostic for brain tumor)
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	1. Bile duct stenosis suspected of cholangiocarcinoma 2. Patients who obtained informed concent 3. 20 years of age or older
Key exclusion criteria	1. Cases in ECOG performance status 4 2. Cases with serious complications in other organs 3. Cases who have difficulty in endoscopic approach via the ampulla of Vater 4. Cases under 20 years of age 5. Cases who don't give informed consent 6. Cases with hypersensitivity porphyrin related substances or its previous history 7. Cases with porphyria 8. Pregnant women or cases who may be pregnant 9. Other cases that the research responsibility (share) person judged inappropriate as the research subject
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hironari Middle name Last name Kato
Organization	Okayama University Hospital
Division name	Departments of Gastroenterology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Muro
Organization	Okayama University Hospital
Division name	Depertment of Endoscopy
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	086-235-7219
Homepage URL
Email	shinm0416@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	SBI Pharmaceuticals Co.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
Tel	086-235-7218
Email	shinm0416@yahoo.co.jp

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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 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 29 Day
Date of IRB	2017 Year 03 Month 21 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029796