UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049290 |
|---|---|
| Receipt number | R000056002 |
| Scientific Title | A retrospective study on the recurrence factors of stone removal by double-balloon assisted endoscopic retrograde cholangiopancreatography for bile duct stones associated with bile duct-jejunal anastomotic stenosis |
| Date of disclosure of the study information | 2022/10/22 |
| Last modified on | 2025/01/11 22:55:59 |
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Basic information
Public title
A retrospective study on the recurrence factors of stone removal by double-balloon assisted endoscopic retrograde cholangiopancreatography for bile duct stones associated with bile duct-jejunal anastomotic stenosis
Acronym
DB-ERCP for bile duct-jejunal anastomotic stenosis
Scientific Title
A retrospective study on the recurrence factors of stone removal by double-balloon assisted endoscopic retrograde cholangiopancreatography for bile duct stones associated with bile duct-jejunal anastomotic stenosis
Scientific Title:Acronym
DB-ERCP for bile duct-jejunal anastomotic stenosis
Region
| Japan |
Condition
Condition
bile duct stones associated with bile duct-jejunal anastomotic stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the recurrence factors of endoscopic retrograde cholangiopancreatography (ERCP) combined with double-balloon enteroscopy for choledocholithiasis associated with choledojejunostomy stricture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
non recurrence period
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DBERCP was performed at our hospital for bile duct-jejunal anastomosis between April 2012 and September 2022.
Key exclusion criteria
with malignant disease
with fistula other than bile duct jejunostomy
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Fukuba |
Organization
Shimane University
Division name
Faculty of Medicine, Internal medicine II
Zip code
6938501
Address
89-1, Enya-cho, Izumo
TEL
0853-20-2190
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
Faculty of Medicien, Internal medicine II
Zip code
6938501
Address
89-1,Enyacho, Izumo
TEL
0853-20-2190
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, Enyacho, 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 | 10 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | 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 (proton pump inhibitors, ursodeoxycholic acid)
4) Primary disease
5) Final surgery (reconstruction method)
6) Date of successful stone removal with DBERCP
7) DBERCP number of times before stone removal
8) Number of balloon dilatations performed before stone removal
9) Maximum diameter of balloon dilation before stone removal
10) Date of confirmation of cholangitis or recurrence of choledocholithiasis after stone removal
Management information
Registered date
| 2022 | Year | 10 | Month | 22 | 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=R000056002
