UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054931 |
|---|---|
| Receipt number | R000062648 |
| Scientific Title | Investigation of Factors Associated with Time to Obstruction or Migration of Self-Expandable Metallic Stents in Distal Malignant Biliary Obstruction |
| Date of disclosure of the study information | 2024/07/20 |
| Last modified on | 2024/07/10 19:12:33 |
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Basic information
Public title
Investigation of Factors Associated with Time to Obstruction or Migration of Self-Expandable Metallic Stents in Distal Malignant Biliary Obstruction
Acronym
Investigation of Factors of TRBO of SEMS in Distal Malignant Biliary Obstruction
Scientific Title
Investigation of Factors Associated with Time to Obstruction or Migration of Self-Expandable Metallic Stents in Distal Malignant Biliary Obstruction
Scientific Title:Acronym
Investigation of Factors of TRBO of SEMS in Distal Malignant Biliary Obstruction
Region
| Japan |
Condition
Condition
distal malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with distal malignant biliary obstruction (DMBO) often experience recurrent biliary obstruction (RBO) after self-expandable metallic stent (SEMS) placement. Factors related to the time to RBO (TRBO) vary across reports and are not well understood. This study aims to identify TRBO-related factors to inform stent treatment strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TRBO-related factors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study included patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for DMBO at our hospital from January 2016 to June 2023 and underwent their first SEMS placement.
Key exclusion criteria
Patients in whom SEMS were placed using percutaneous transhepatic biliary drainage or endoscopic ultrasound-guided biliary drainage were excluded.
Target sample size
119
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | Kumagai |
Organization
Kimitsu Chuo Hospital
Division name
Department of Gastroenterology
Zip code
2928535
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438361071
kuma920jun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | Kumagai |
Organization
Kimitsu Chuo Hospital
Division name
Department of Gastroenterology
Zip code
2928535
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438361071
Homepage URL
kuma920jun@yahoo.co.jp
Sponsor or person
Institute
Kimitsu Chuo 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
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu, Chiba
Tel
0438361071
kuma920jun@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
| 2024 | Year | 07 | 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
119
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 | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who underwent endoscopic retrograde cholangiopancreatography for distal malignant biliary obstruction and had their first transpapillary self-expandable metallic stent placement at our institution from January 2016 to June 2023 were retrospectively reviewed.
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062648
| 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 |
