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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000046702 |
Receipt No. | 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 | 2022/01/23 |
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 |
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Condition | ||
Condition | unresectable malignant hilar biliary obstruction | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Natioinal cancer center hospital
department of hepatobiliary and pancreatic oncology |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information | multicenter prospective observational study |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053279 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |