UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008275 |
|---|---|
| Receipt number | R000009694 |
| Scientific Title | A Multi-Center, Prospective Study of endoscopic shincterotomy combined with large balloon dilation for removal of difficult common bile duct stones |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2014/09/08 14:34:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multi-Center, Prospective Study of endoscopic shincterotomy combined with large balloon dilation for removal of difficult common bile duct stones
Acronym
ESLBD study
Scientific Title
A Multi-Center, Prospective Study of endoscopic shincterotomy combined with large balloon dilation for removal of difficult common bile duct stones
Scientific Title:Acronym
ESLBD study
Region
| Japan |
Condition
Condition
Difficult common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic sphincterotomy combined with large balloon dilation for removal of difficult common bile duct stones
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and successful rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who gives written informed consent.
2) 20 yeare old<=
3) Stone size 13mm<= or stone size 10mm and 3<=
4) Hospitalized patients
5) Use of balloon(5.5cm balloon)
Key exclusion criteria
1) Patients for whom endoscopic biliary drainage is difficult(Bil-2, R-Y).
2) Impossible of EST
3) Papilla in doverticulum
4) Diatal stricture of bile duct
5) Patients considered ineligible for this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio TSUYUGUCHI |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
sakai4754@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji SAKAI |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
sakai4754@yahoo.co.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
| 2012 | Year | 10 | 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
| 2012 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2012 | Year | 06 | Month | 27 | Day |
Last modified on
| 2014 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009694
