UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025048 |
|---|---|
| Receipt number | R000028829 |
| Scientific Title | Utility of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for Difficult Common Bile Duct Stones |
| Date of disclosure of the study information | 2019/11/29 |
| Last modified on | 2021/06/22 21:16:00 |
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Basic information
Public title
Utility of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for Difficult Common Bile Duct Stones
Acronym
Utility of Direct POC Using a Multibending Ultraslim Endoscope for Difficult CBD Stones
Scientific Title
Utility of Direct Peroral Cholangioscopy Using a Multibending Ultraslim Endoscope for Difficult Common Bile Duct Stones
Scientific Title:Acronym
Utility of Direct POC Using a Multibending Ultraslim Endoscope for Difficult CBD stones
Region
| Asia(except Japan) |
Condition
Condition
Y
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the utility of direct POC for lithotripsy in patients with difficult bile duct stones using a newly developed MB ultraslim endoscope
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete ductal clearance
Key secondary outcomes
Technical success of direct POC
Technical success of direct POC-guided lithotripsy
Rate of additional ML use
Number of ERCP sessions for complete stone removal
Procedure time for direct POC-guided lithotripsy
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)Patients with bile duct stones in whom conventional endoscope stone removal, including mechanical lithotripsy (ML), had failed
2)Previous sphincteroplasty such as endoscopic sphincterotomy (EST) and/or endoscopic papillary balloon dilation (EPBD)
3) distal common bile duct (CBD) dilation more than 8 mm
Key exclusion criteria
1)Stricture of the distal CBD
2)Diagnosis of periampullary cancer
3)Presence of intrahepatic duct (IHD) stones
4)Bleeding tendency : platelet count < 60,000/mm3 or international normalized ratio > 1.5
5)Refusal to participate
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
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
yunnah@schmc.ac.kr
Sponsor or person
Institute
SoonChunHyang University School of Medicine
Institute
Department
Personal name
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
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
| 2021 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
