UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046702 |
|---|---|
| Receipt number | R000053279 |
| Scientific Title | The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study |
| Date of disclosure of the study information | 2022/01/24 |
| Last modified on | 2025/08/10 09:46:08 |
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Basic information
Public title
The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Acronym
YABUSAME study
Scientific Title
The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Scientific Title:Acronym
YABUSAME 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 clinical outcome of patients who had malignant hilar biliary obstruction and placed YABUSAME, uncovered self expandable metallic stent, will be investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the non-recurrence rate of biliary obstruction at 6 months
Key secondary outcomes
technical success rate
clinical success rate
the non-recurrence rate of biliary obstruction at 3 months and 12 months
time to recurrence of biliary obstruction
overall survival time
adverse event
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
Patients with unresectable malignant hilar biliary obstruction who are judgeded the necessity of biliary drainage and planned to be placed YABUSAME.
Patients who are planned exchange the placed stent to YABUSAME.
P.S. (ECOG): 0, 1, 2
Age: 18 years or older
Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
Patients with unremovable SEMS at hilar portion who are planned additionally to be placed YABUSAME.
Patients who are planned to be placed YABUSAME via the EUS interventinal route.
Patients who do not have hilar obstruction.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Okusaka |
Organization
Natioinal cancer center hospital
Division name
department of hepatobiliary and pancreatic oncology
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tokusaka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Takeshita |
Organization
Natioinal cancer center hospital
Division name
department of hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ktakeshi@ncc.go.jp
Sponsor or person
Institute
Natioinal cancer center hospital
department of hepatobiliary and pancreatic oncology
Institute
Department
Personal name
Funding Source
Organization
Natioinal cancer center hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Natioinal cancer center hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-224
Org. issuing International ID_1
Natioinal cancer center hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学、埼玉医科大学総合医療センター、三重大学医学部附属病院、自治医大さいたま医療センター、大阪医科薬科大学、大阪国際がんセンター、筑波大学附属病院、帝京大学医学部附属溝口病院、北海道大学病院、国際医療福祉大学三田病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000053279
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/pmid/39971830/
Number of participants that the trial has enrolled
45
Results
Of 45 enrolled patients, 43 patients underwent biliary drainage, including 42 patients who underwent YABUSAME
placement. Technical and clinical success rates were 93.2% (41/45) and 79.1% (34/45), respectively. The incidence rate of early postprocedural adverse events was 2.2%. The stent patency rate at 6 months was 55.3%. The median time to RBO was 231 days. The median OS was 125 days.
Results date posted
| 2025 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The eligibility criteria included patients (1) with clinically and radiographically diagnosed inoperable MHBO, (2) who required biliary drainage with UCSEMS placement, (3) were more than 18 years of age, and (4) who provided written informed consent. The Bismuth classification was not con-
considered for eligibility, and type 1 was eligible.
Participant flow
Registered at multi-center after confirmation of eligibility criteria
Adverse events
No adverse events occurred during the procedure. One patient experienced an early adverse event of moderate nonobstructive cholangitis. No late adverse events other than RBO were observed.
Outcome measures
The stent patency rate at 6 months
RBO
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
multicenter prospective observational study
Management information
Registered date
| 2022 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053279
