UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030476 |
|---|---|
| Receipt number | R000034562 |
| Scientific Title | Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2024/01/10 18:41:36 |
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Basic information
Public title
Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study
Acronym
Usefulness and safety of EUS-BD for cases difficult to treat with ERCP in the community:prospective cohort study
Scientific Title
Usefulness and safety of EUS-BD for malignant bile duct obstruction difficult to treat with ERCP in the community;prospective cohort study
Scientific Title:Acronym
Usefulness and safety of EUS-BD for cases difficult to treat with ERCP in the community:prospective cohort study
Region
| Japan |
Condition
Condition
Patients with malignant biliary obstruction difficult to treat by ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
identify the usefulness and safety of EUS-BD regional collaboration system in patients with malignant biliary obstruction who are difficult to treat by ERCP at a regional hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Internal fistula rate of biliary stent
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
over 20 years old
Cases requiring biliary duct drainage
Cases with biliary obstruction by malignant tumor
Cases in which biliary drainage by ERCP was unsuccessful at regional hospitals
Key exclusion criteria
Cases which endoscopes can not be done
Informed consent can not be obtained
Cases scheduled for radical surgery
Cases judged by investigator as inappropriate as subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama city, Wakayama
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tamura |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama city, Wakayama
TEL
073-447-2300
Homepage URL
ttakashi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Research Ethics Committee of Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Wakayama
Tel
0734472300
wa-rinri@wakayama-med.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
| 2017 | Year | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Internal fistulization rate Clinical improvement rate
Treatment time
Frequency of adeverse event
Number of Re-intervention
Procedure success rate
Stent patent duration
Management information
Registered date
| 2017 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034562
