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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025048
Receipt No. R000028829
Scientific Title Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones
Date of disclosure of the study information 2019/11/29
Last modified on 2016/11/29

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Basic information
Public title Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones
Acronym Usefulness of Direct POC Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones
Scientific Title Usefulness of Direct Peroral Cholangioscopy Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones
Scientific Title:Acronym Usefulness of Direct POC Using a Multibending Ultra-slim Endoscope After Removal of Bile Duct Stones
Region
Asia(except Japan)

Condition
Condition Y
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we evaluated the usefulness of evaluation for BD using a DPOC with a multibending ultraslim endoscope after stone removal.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic efficacy of direct POC for lesions difficult to be diagnosed by cholangiogram
Key secondary outcomes Risk factor for focal bile duct lesions difficult to be diagnosed by cholangiogram
Technical success rate of direct POC
Technical success rate of direct POC-guided biopsy
Diagnostic accuracy of direct POC-guided biopsy
Technical success rate of direct POC-guided stone removal
Total procedure time for direct POC
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Direct POC using a multibending ultra-slim endoscope
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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria 1)Bile duct stones with dilated distal common bile duct more than 8 mm
2)Patients received balloon-occluded cholangiography for confirmation of ductal clearance after stone extraction
3)Previous sphincteroplasty
Key exclusion criteria 1)Diffuse stricture on the distal common bile duct
2)Tumorous condition invading the bile duct or ampulla of Vater
3)Contraindication for ERCP
4)Bleeding tendency
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization Department of Internal Medicine, 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 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 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 SoonChunHyang University School of Medicine
Organization
Division
Category of Funding Organization Outside Japan
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
2019 Year 11 Month 29 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 05 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 11 Month 29 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028829

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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