UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011533 |
|---|---|
| Receipt number | R000013479 |
| Scientific Title | Is newly modified endoscopic large balloon dilatation without endoscopic sphincterotomy effective for difficult bile duct stone removal? |
| Date of disclosure of the study information | 2013/08/20 |
| Last modified on | 2014/03/04 14:59:47 |
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Basic information
Public title
Is newly modified endoscopic large balloon dilatation without endoscopic sphincterotomy effective for difficult bile duct stone removal?
Acronym
non-EST+EPLBD Efficacy and safety
Scientific Title
Is newly modified endoscopic large balloon dilatation without endoscopic sphincterotomy effective for difficult bile duct stone removal?
Scientific Title:Acronym
non-EST+EPLBD Efficacy and safety
Region
| Japan |
Condition
Condition
Common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of non-EST and the minimum dilation in EPLBD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complete stone clearance
Key secondary outcomes
initial complete stone clearance, number of session,
application of mechanical lithotripsy, adverse events
disappeared waist vs not disappeared waist
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Sphincteroplasty
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Distal CBD diameter 11mm more
Maximum CBD stone diameter 10mm more
Key exclusion criteria
coagrapathy
need for precutting
acute cholangitis, acute pancreas
previous EST
distal CBD 21mm more
benign or malignant biliary stricture
not agreement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigefumi Omuta |
Organization
Toho university ohashi medical center
Division name
Gastroenterology and Hepatoplogy
Zip code
Address
2-17-6 ohashi meguro-ku
TEL
03-3468-1251
muta@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigefumi Omuta |
Organization
Toho university ohashi medical center
Division name
Gastroenterology and Hepatoplogy
Zip code
Address
2-17-6 Meguro-ku Ohashi
TEL
81-3-3468-1251
Homepage URL
muta@oha.toho-u.ac.jp
Sponsor or person
Institute
Toho university ohashi medical center, division of gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 30 | 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
| 2013 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013479
