UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063087 |
|---|---|
| Receipt number | R000071924 |
| Scientific Title | Risk Factors for Early Recurrent Biliary Obstruction After Multiple Inside Plastic Stent Placement for Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Cohort Study |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 20:56:20 |
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Basic information
Public title
Risk Factors for Early Recurrent Biliary Obstruction After Multiple Inside Plastic Stent Placement for Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Cohort Study
Acronym
MIPS-RBO Study
Scientific Title
Risk Factors for Early Recurrent Biliary Obstruction After Multiple Inside Plastic Stent Placement for Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Cohort Study
Scientific Title:Acronym
MIPS-RBO Study
Region
| Japan |
Condition
Condition
Unresectable malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the cumulative incidence and risk factors for early recurrent biliary obstruction (RBO) in patients with unresectable malignant hilar biliary obstruction who underwent ERCP-guided placement of multiple inside plastic stents (iPS). These findings may help optimize the timing of scheduled stent exchanges and strategies for biliary drainage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of recurrent biliary obstruction (RBO) within 3 and 6 months after multiple inside plastic stent (iPS) placement and factors associated with RBO
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older
2. Patients who underwent multiple inside plastic stent (iPS) placement at the last planned endoscopic biliary drainage (LPEBD) during the initial planned endoscopic drainage for unresectable malignant hilar biliary obstruction between April 1, 2020 and March 31, 2026
Key exclusion criteria
1. Patients who declined the use of their clinical information through the opt-out process
2. Patients considered inappropriate for inclusion in the study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Uemura |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
ueshin550621@gmail.com
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kaneko |
Organization
Iwata City Hospital
Division name
Department of Gastroenterology
Zip code
4388550
Address
521, Ookubo, Iwata-shi, Shizuoka, Japan
TEL
08051319901
Homepage URL
meganerock10@gmail.com
Sponsor or person
Institute
First Department of Internal Medicine, Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
First Department of Internal Medicine, Gifu University Hospital
Address
1-1 Yanagido, Gifu
Tel
058-230-6308
ueshin550621@gmail.com
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
| 2026 | Year | 09 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2033 | Year | 03 | 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
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071924
