UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050564 |
|---|---|
| Receipt number | R000057589 |
| Scientific Title | Evaluation of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction |
| Date of disclosure of the study information | 2023/03/12 |
| Last modified on | 2024/02/25 12:14:24 |
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Basic information
Public title
Evaluation of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Acronym
Evaluation of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Scientific Title
Evaluation of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Scientific Title:Acronym
Evaluation of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Region
| Japan |
Condition
Condition
The patients who received the biliary drainage for the unresectable malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent patency of each stent placement methods for unresectable malignant hilar biliary obstruction
Key secondary outcomes
The technical and clinical success rate of each stent placement
Adverse events
Overall survival
The technical and clinical success rate of endoscopic reintervention
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
more than 20-years-old
The patients who received the unilateral or bilateral inside plastic stent placement for unresectable malignant hilar biliary obstruction
Key exclusion criteria
The patients who are otherwise judged by the investigator to be ineligible to participate in the study.
The case of the malignant hilar biliary obstruction who conducted unilateral metallic stent placement
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu municipal hospital
Division name
Gastoroenterology
Zip code
500-8513
Address
7-1 Kasima-cho, Gifu city, Gifu
TEL
058-251-1101
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu municipal hospital
Division name
Gastoroenterology
Zip code
500-8513
Address
7-1 Kasima-cho, Gifu city, Gifu
TEL
058-251-1101
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Gifu municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu municipal hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu municipal hospital
Address
7-1 Kasima-cho, Gifu city, Gifu
Tel
058-251-1101
mkobdkl@yahoo.co.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
| 2023 | Year | 03 | Month | 12 | 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
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057589
