UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049303 |
|---|---|
| Receipt number | R000056157 |
| Scientific Title | A retrospective study on technique associated with endoscopic retrograde cholangiopancreatography for abdominal injury |
| Date of disclosure of the study information | 2022/11/15 |
| Last modified on | 2025/01/11 22:56:30 |
* 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 retrospective study on technique associated with endoscopic retrograde cholangiopancreatography for abdominal injury
Acronym
ERCP for abdominal injury
Scientific Title
A retrospective study on technique associated with endoscopic retrograde cholangiopancreatography for abdominal injury
Scientific Title:Acronym
ERCP for abdominal injury
Region
| Japan |
Condition
Condition
Bile duct or pancreatic duct injury
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and risks of endoscopic retrograde cholangiopancreatography (ERCP)-related procedures for abdominal injuries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Length of hospital stay
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) A patient who underwent ERCP due to suspicion of biliary fistula.
2) Patients who underwent ERCP due to suspected pancreatic duct injury.
Key exclusion criteria
1) Patients undergoing palliative treatment for malignant disease
2) Patients who self-extracted the drain due to delirium, dementia, etc.
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
6938501
Address
89-1, Enya-cho, Izumo
TEL
0853202190
fnat98@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Fukuba |
Organization
Shimane University
Division name
Internal medcine II
Zip code
6938501
Address
89-1, Enya-cho, Izumo
TEL
0853202190
Homepage URL
fnat98@yahoo.co.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
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
| 2022 | Year | 11 | Month | 15 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Age and gender
2) Presence or absence of diabetes
3) Oral medication history (antithrombotic drugs)
4) Damaged site of bile duct or pancreatic duct
5) Date of bile duct injury or pancreatic duct injury
6) Date of endoscopic retrograde cholangiopancreatography
7) Number of endoscopic retrograde cholangiopancreatography
8) the procedure performed
9) Presence or absence of additional treatment
10) Presence or absence of complications due to endoscopic retrograde cholangiopancreatography and related therapeutic procedures
11) Drainage end date
12) Date of discharge at home
Management information
Registered date
| 2022 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056157
