UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020465 |
|---|---|
| Receipt number | 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 23:10:26 |
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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
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
yunnah@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023647
