UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053594 |
|---|---|
| Receipt number | R000061159 |
| Scientific Title | A retrospective study on endoscopic treatment of pancreaticojejunostomy stricture by double-balloon assisted endoscopic retrograde cholangiopancreatography |
| Date of disclosure of the study information | 2024/02/11 |
| Last modified on | 2024/02/10 23:33:06 |
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Basic information
Public title
A retrospective study on endoscopic treatment of pancreaticojejunostomy stricture by double-balloon assisted endoscopic retrograde cholangiopancreatography
Acronym
A retrospective study on endoscopic treatment of pancreaticojejunostomy stricture by double-balloon assisted endoscopic retrograde cholangiopancreatography
Scientific Title
A retrospective study on endoscopic treatment of pancreaticojejunostomy stricture by double-balloon assisted endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym
A retrospective study on endoscopic treatment of pancreaticojejunostomy stricture by double-balloon assisted endoscopic retrograde cholangiopancreatography
Region
| Japan |
Condition
Condition
pancreaticojejunostomy stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effectiveness and complications of endoscopic treatment using endoscopic retrograde cholangiopancreatography (ERCP) combined with double balloon enteroscopy for bile duct stones associated with pancreaticojejunostomy anastomotic stricture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, weight
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
1) Cases in which double balloon endoscope-assisted ERCP (BAE-ERCP) was performed for pancreaticojejunostomy between April 2012 and September 2023.
Key exclusion criteria
1) Fistula other than pancreaticojejunostomy
Target sample size
60
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
No
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 | 02 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 11 | 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
Independent factors include patient factors such as age, gender, presence or absence of diabetes mellitus before surgery for the primary disease, primary disease, final surgical method (including reconstruction method), and procedural factors such as maximum diameter of balloon dilatation, size and number of stents. do. On the other hand, HbA1c and body weight were collected as dependent variables, univariate analysis was performed for each independent factor, and each factor was compared using logistic regression analysis. Univariate analysis will also be performed on the success rate of the procedure and the frequency of adverse events using each independent factor.
Management information
Registered date
| 2024 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061159
| 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 |
