UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055845 |
|---|---|
| Receipt number | R000063821 |
| Scientific Title | A retrospective study on the success rate of balloon endoscopy combined with endoscopic cholangiopancreatography for reconstructed intestine after duodenal preservation surgery |
| Date of disclosure of the study information | 2024/10/16 |
| Last modified on | 2025/11/08 11:34:38 |
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Basic information
Public title
A retrospective study on the success rate of balloon endoscopy combined with endoscopic cholangiopancreatography for reconstructed intestine after duodenal preservation surgery
Acronym
A retrospective study on the success rate of balloon endoscopy combined with endoscopic cholangiopancreatography for reconstructed intestine after duodenal preservation surgery
Scientific Title
A retrospective study on the success rate of balloon endoscopy combined with endoscopic cholangiopancreatography for reconstructed intestine after duodenal preservation surgery
Scientific Title:Acronym
A retrospective study on the success rate of balloon endoscopy combined with endoscopic cholangiopancreatography for reconstructed intestine after duodenal preservation surgery
Region
| Japan |
Condition
Condition
Biliary and pancreatic diseases with reconstructed intestine after duodenal preservation surgery
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the success rate and factors for success of endoscopic retrograde cholangiopancreatography combined with balloon endoscopy (BAE-ERCP) in cases of intestinal reconstruction after duodenal-preserving surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BAE-ERCP success 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases in which BAE-ERCP was performed for intestinal reconstruction after duodenum-preserving surgery between April 2012 and August 2024.
Key exclusion criteria
1) An endoscope can be inserted from the duodenal orifice.
2) There is a biliary-digestive fistula.
Target sample size
290
Research contact person
Name of lead principal investigator
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | FUKUBA |
Organization
Shimane University
Division name
Internal medicine II
Zip code
693-8501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
nfukuba@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | FUKUBA |
Organization
Shimane University
Division name
Internal medicine II
Zip code
693-8501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
Homepage URL
nfukuba@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee,Shimane University Faculty of Medicine
Address
89-1,Enya-cho, Izumo, Shimane,Japan
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | 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=R000063821
