UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Acronym	Efficacy and safety of cholangioscopy for biliary disease
Scientific Title	Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Scientific Title:Acronym	Efficacy and safety of cholangioscopy for biliary disease
Region	Japan

Condition
Condition	Biliary disease
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy and safety of peroral direct cholangioscopy with an ultrathin endoscope for biliary disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visibility of biliary lesion (using LCI and BLI)
Key secondary outcomes	1.Success rate of scope insertion to bile duct 2.Ability to procedure(forceps biopsy etc) 3.Procedure time 4.Adverse event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Patient need to examine the biliary lesion with cholangioscopy. 2. Possible to get written informed consent from patients. 3. Ages 20 and older.
Key exclusion criteria	1. The size of bile duct less than 8mm on ERC 2. Patients with performance status 3 or 4 3. Patients with severe complications to other organs. 4. Patients with severe coagulation dysfunction. 5. Patients without informed consent. 6. Patients judged inappropriate by chief medical examiner.
Target sample size	40

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

Public contact
Name of contact person	1st name Middle name Last name Kazuyuki Matsumoto
Organization	Okayama University Hospital
Division name	Department of Endoscopy
Zip code
Address	2-5-1 Shikata-cho,Kita-ku Okayama-city Okayama
TEL	086-235-7219
Homepage URL
Email	matsumotokazuyuki0227@yahoo.co.jp

Sponsor
Institute	Okayama university hospital
Institute
Department

Funding Source
Organization	Okayama university hospital
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	2018 Year 04 Month 09 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	9
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	2018 Year 03 Month 16 Day
Date of IRB	2018 Year 03 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry	2022 Year 01 Month 31 Day
Date trial data considered complete	2022 Year 01 Month 31 Day
Date analysis concluded	2022 Year 01 Month 31 Day

Other
Other related information	Primaly endopoint Visibility of biliary lesion (using LCI and BLI) Secondary endopoints 1.Success rate of scope insertion to bile duct 2.Ability to procedure(forceps biopsy etc) 3.Procedure time 4. Adverse event

Management information
Registered date	2018 Year 04 Month 08 Day
Last modified on	2022 Year 01 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036682