UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058935 |
|---|---|
| Receipt number | R000067402 |
| Scientific Title | The related factors of time to recurrent biliary obstruction after the self-expanded metallic stent placement for the distal malignant biliary obstruction. |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/29 20:55:30 |
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Basic information
Public title
The related factors of time to recurrent biliary obstruction after the self-expanded metallic stent placement for the distal malignant biliary obstruction.
Acronym
The related factors of TRBO after SEMS placement for the distal malignant biliary obstruction.
Scientific Title
The related factors of time to recurrent biliary obstruction after the self-expanded metallic stent placement for the distal malignant biliary obstruction.
Scientific Title:Acronym
The related factors of TRBO after SEMS placement for the distal malignant biliary obstruction.
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 related factors of TRBO of SEMS for the distal malignant biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the related factors of TRBO of SEMS for the distal malignant biliary obstruction.
Key secondary outcomes
The reason for recurrent biliary obstruction after SEMS placement.
The comparison of patients' characteristics, prognosis, and the rate of adverse events after SEMS placement with or without the related factor for TRBO of SEMS.
The effectiveness of secondary SEMS placement.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
>17-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
600
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunami General Hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, Gifu 501-6062, Japan
TEL
0583880111
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Matsunaimi general hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, Gifu 501-6062, Japan
TEL
058-388-0111
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Matsunami General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Matsunaimi general hospital
Address
Dendai 185-1, Kasamatsu-cho, Hashima-gun, Gifu 501-6062, Japan
Tel
058-388-0111
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
| 2025 | Year | 08 | Month | 29 | 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
Suspended
Date of protocol fixation
| 2022 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067402
