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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000020465
Receipt No. R000023647
Scientific Title SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study
Date of disclosure of the study information 2017/08/26
Last modified on 2016/01/06

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Basic information
Public title SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study
Acronym SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy for the Managing Biliary Lesions
Scientific Title SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy as a Single-Operator Peroral Cholangioscopy for the Managing Biliary Lesions: a Prospective Comparative Study
Scientific Title:Acronym SpyGlass Direct Visualization System vs. Direct Peroral Cholangioscopy for the Managing Biliary Lesions
Region
Asia(except Japan)

Condition
Condition Biliary diseases
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the procedure success rate of POC using SpyGlass DVS and Direct POC using a mutibending ultraslim endoscope for diagnosis and treatment of bile duct diseases
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure success rate
Key secondary outcomes Technical success rate
Procedure success rate according to the type of lesion
Success rate of diagnostic and therapeutic procedure
Total procedure time for SOCs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 SOC using SpyGlass DVS
Interventions/Control_2 SOC using direct POC
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Biliary diseases indicated for SOC
Previous sphincteroplasty (i.e. EST, EPBD)
Dilated distal CBD>8mm
Key exclusion criteria Diffuse stricture on the distal CBD
Periampullary cancer
Contraindication for endoscopic procedure
Bleeding tendency (INR>1.5 or platelet count < 60,000/mm3)
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name 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
Zip code
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 School of Medicine
Institute
Department

Funding Source
Organization none
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
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 08 Month 26 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 Suspended
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2016 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023647

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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