UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063332 |
|---|---|
| Receipt number | R000072487 |
| Scientific Title | The Role of Double bare stents for distal malignant biliary strictures: A Multicenter Retrospective Study |
| Date of disclosure of the study information | 2026/10/19 |
| Last modified on | 2026/10/18 20:08:22 |
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Basic information
Public title
The Role of Double bare stents for distal malignant biliary strictures: A Multicenter Retrospective Study
Acronym
The Role of Double bare stents for distal malignant biliary strictures
Scientific Title
The Role of Double bare stents for distal malignant biliary strictures: A Multicenter Retrospective Study
Scientific Title:Acronym
The Role of Double bare stents for distal malignant biliary strictures
Region
| Japan |
Condition
Condition
Distal malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the usefulness and safety of the EGIS biliary stent double bare type for unresectable distal malignant biliary strictures through a retrospective comparative study against fully covered self expandable metal stents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TRBO (Time to recurrent biliary obstruction), adverse events
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent biliary stent placement using DBS or FCSEMS for the diagnosis of distal malignant biliary stricture
Key exclusion criteria
Patients who have declined to participate in the study
Patients whose post-treatment progress cannot be tracked (e.g., due to transfer to another hospital immediately after treatment)
Patients for whom the data points required for analysis cannot be sufficiently extracted from their medical records
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo medical university
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi Prefecture
TEL
0282861111
sakuma-f@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Fumi |
| Middle name | |
| Last name | Sakuma |
Organization
Dokkyo medical university
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi Prefecture
TEL
0282861111
Homepage URL
sakuma-f@dokkyomed.ac.jp
Sponsor or person
Institute
Dokyyo medical university
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
Dokkyo medical university
Address
880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun, Tochigi Prefecture
Tel
0282861111
sakuma-f@dokkyomed.ac.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
| 2026 | Year | 10 | Month | 19 | 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
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study on the clinical outcome of patients who underwent biliary stent placement using either a DBS or an FCSEMS for the management of distal malignant biliary strictures.
Management information
Registered date
| 2026 | Year | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072487
