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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011533
Receipt No. 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

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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
Email 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
Email muta@oha.toho-u.ac.jp

Sponsor
Institute Toho university ohashi medical center, division of gastroenterology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013479

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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