UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046862 |
|---|---|
| Receipt number | R000053464 |
| Scientific Title | The evaluation of the effectiveness of Ursodeoxycholic acid for the self-expanded metallic stent in the distal malignant biliary obstruction case. |
| Date of disclosure of the study information | 2022/02/10 |
| Last modified on | 2022/12/19 11:45:18 |
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Basic information
Public title
The evaluation of the effectiveness of Ursodeoxycholic acid for the self-expanded metallic stent in the distal malignant biliary obstruction case.
Acronym
The evaluation of the effectiveness of Ursodeoxycholic acid for the self-expanded metallic stent placement
Scientific Title
The evaluation of the effectiveness of Ursodeoxycholic acid for the self-expanded metallic stent in the distal malignant biliary obstruction case.
Scientific Title:Acronym
The evaluation of the effectiveness of Ursodeoxycholic acid for the self-expanded metallic stent placement
Region
| Japan |
Condition
Condition
The case of the distal malignant biliary obstruction with self-expanded metallic stent placement.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship of Ursodeoxycholic acid, self-expanded metallic stent placement and TRBO in the distal malignant biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the relationship of the self-expanded metallic stent placement with or without Ursodeoxycholic acid and TRBO.
Key secondary outcomes
The reason for recurrent biliary obstruction after SEMS placement.
The evaluation of the factors for the recurrent biliary obstruction and TRBO
Evaluation of the causative agent of cholangitis associated with stent occlusion
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
>20-years-old
The case of distal malignant biliary obstruction with SEMS placement.
Key exclusion criteria
The patients who are otherwise judged by the investigator to be ineligible to participate in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu Municipal Hospital
Division name
Department of Gastroenterology
Zip code
5008513
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
Department of Gastroenterology
Zip code
5008513
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
Department of Gastroenterology
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
岐阜市民病院、岐阜大学医学部附属病院、岐阜県総合医療センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 10 | 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 | 02 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2022 | 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
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053464
