UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019610 |
|---|---|
| Receipt number | R000022188 |
| Scientific Title | Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2022/11/08 09:08:44 |
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Basic information
Public title
Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Acronym
Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Scientific Title
Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Scientific Title:Acronym
Multicenter randomized controlled trial of endoscopic treatment for conventional bile duct stone:ordinary sphincterotomy vs.papillary balloon dilation with minor sphincterotomy
Region
| Japan |
Condition
Condition
Bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the utility and safety between the ordinary sphincterotomy and the minor sphincterotomy with balloon dilation in the ensoscopic treatment for common bile duct stones of <= 12 mm in diameter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The necessity of mechanical lithotripsy
Key secondary outcomes
Fluoroscopy time, procedure time, complete stome removal, and
complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ordinary sphincterotomy
Interventions/Control_2
papillary balloon dilation with minor sphincterotomy
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
1)Untreated Duodenum main
2)Bile duct stones of <= 12 mm
3)Written informed concent
Key exclusion criteria
1)Severe bleeding tendency
2)Post-operation of stomach, duodenum, bile duct
3)Non-adaptive case of endoscopic procedure
4)Other problem(s) in the opinion of the Investigator(s)
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Hisa |
Organization
Saku Central Hospital Advanced Care Center
Division name
Gastroenterology
Zip code
385-0051
Address
Nakagomi 3400-28, Saku, Nagano 385-0051 Japan
TEL
0267-62-8181
hisa.takeshi@sakuhp.or.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Niimi |
Organization
Saku Central Hospital Advanced Care Center
Division name
Clinical Research Center
Zip code
385-0051
Address
3400-28 Nakagomi, Saku, Nagano 385-0051 JAPAN
TEL
0267-62-8181
Homepage URL
ctroffice@sakuhp.or.jp
Sponsor or person
Institute
Saku Central Hospital Advanced Care Center
Institute
Department
Personal name
Funding Source
Organization
Shinshu Public Utility Foundation for Promotion of Medical Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saku Central Hospital Group Research Ethics Committee
Address
197 Usuda, Saku, Nagano,384-0393 JAPAN
Tel
0267-82-3131
irboffice@sakuhp.or.jp
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
帯広厚生病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 16 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022188
