UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020613 |
|---|---|
| Receipt number | R000023797 |
| Scientific Title | The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/01/21 15:21:05 |
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Basic information
Public title
The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Acronym
The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Scientific Title
The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Scientific Title:Acronym
The efficacy and safety of balloon dilation and stent deployment for bilioenteric anastomotic stricture with surgically altered anatomy by double-balloon enteroscope
Region
| Japan |
Condition
Condition
bilioenteric anastomotic stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the efficacy and safety of balloon dilation and stent deployment for the biliary anastomotic stricture by double balloon enteroscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year biliary anastomotic stricture recurrence free rates
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who suspected to the bilioenteric anastomotic stricture
Key exclusion criteria
1)Patients with performance status 4
2)Age<20
3)Patients with a history of balloon dilation for the biliary anastomotic stricture
4)Patients with the biliary anastomotic stricture due to malignant disease
5)Patients after living-donor liver transplantation and deceased donor liver transplantaion
6)Patients without informed concent
7)patients who are judged inappropriate by chief medical examiner
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tomoda |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-4-1 Shikata-cho Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
tomotake79@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
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
Address
Tel
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
| 2016 | Year | 03 | Month | 01 | 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
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: prospective cohort study
Recruiting methods of objects: all the patients who conform to the criteria visiting to Okayama University Hospital and three other hospitals affiliated to the Okayama University between March 2016 and March 2020
Measuring item: Clinical signs and liver function were followed up at three months, six months and twelve months after treatment.
Management information
Registered date
| 2016 | Year | 01 | Month | 18 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023797
| 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 |
