UMIN-CTR Clinical Trial

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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