UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001201 |
|---|---|
| Receipt number | R000001449 |
| Scientific Title | Evaluation of treatment safety and efficacy of Endoscopic Sphincterotomy by Endocut mode |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2015/08/30 10:17:17 |
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Basic information
Public title
Evaluation of treatment safety and efficacy of Endoscopic Sphincterotomy by Endocut mode
Acronym
Endocut, 2008
Scientific Title
Evaluation of treatment safety and efficacy of Endoscopic Sphincterotomy by Endocut mode
Scientific Title:Acronym
Endocut, 2008
Region
| Japan |
Condition
Condition
gallstone in the common bile duct and stricture of the bile duct
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment safety and efficacy of Endoscopic Sphincterotomy by Endocut mode
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety such as postoperative pancreatitis
Key secondary outcomes
Efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EST by Endocut mode
Interventions/Control_2
standard EST
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients with gallstone in the common bile duct and stricture of the bile duct that are indication for EST
Key exclusion criteria
the patients with known bleeding disorders including patients on anticoagulants
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma Universithy Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-15 Showa, Maebashi, Gunma, 371-8511, Japan
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-15 Showa, Maebashi, Gunma, 371-8511, Japan
TEL
027-220-8127
Homepage URL
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Gunma Gastroenterological Study Group
Institute
Department
Personal name
Funding Source
Organization
Gunma Gastroenterological Study Group
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
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 19 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
