UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021009 |
|---|---|
| Receipt number | R000024247 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2016/02/14 |
| Last modified on | 2016/04/23 18:04:17 |
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Basic information
Public title
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)
Acronym
computed virtual chromoendoscopy using i-scan versus white light in the evaluation of biliary tract lesions
Scientific Title
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)
Scientific Title:Acronym
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
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
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
| 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
Institute
Department
Personal name
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)
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
| 2016 | Year | 02 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024247
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
