UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Direct peroral cholangioscopic diagnosis of bile duct lesions by high definition ultraslim endoscopy combined with computed virtual chromoendoscopy using i-scan; a pilot study (with videos)
Title of the study (Brief title)	computed virtual chromoendoscopy using i-scan versus white light in the evaluation of biliary tract lesions
Region	Asia(except Japan)

Condition
Condition	biliary polypoid and elevated lesions
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of direct POC alone and in conjunction with NBIori-scan for the diagnosis of biliary polypoid and elevated lesions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic efficacy of direct POC with NBI or i-scan in biliary polypoid and elevated lesions.
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	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	DPOC with NBI
Interventions/Control_2	DPOC with i-scan
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	18 years-old <
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Intraductal bile duct mucosal lesion 2. Bile duct diameter >8mm 3. A previous sphincteroplasty such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP.
Key exclusion criteria	1. a bleeding tendency (international normalized ratio >1.5 or platelet count <50,000/mm3) 2. diffuse stricture of the distal CBD, evidence of pancreatic cancer or tumor at the ampulla of Vater 3. contraindications for endoscopic retrograde cholangiography
Target sample size	25

Research contact person
Name of lead principal investigator	Jong Ho Moon
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Address	Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 420-767, Korea
TEL	+82-32-621-5094
Email	jhmoon@schmc.ac.kr

Public contact
Name of contact person	Yun Nah Lee
Organization	Department of Internal Medicine, Soon Chun Hyang University School of Medicine
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Address	Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL	+82-32-621-5094
Homepage URL
Email	yunnah@schmc.ac.kr

Sponsor
Institute	SoonChunHyang 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	SoonChunHyang University
Organization
Division
Category of Funding Organization	Non profit foundation
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	2016 Year 02 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 09 Month 10 Day
Anticipated trial start date	2009 Year 09 Month 20 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	2016 Year 02 Month 13 Day
Last modified on	2016 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024247