UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039752 |
|---|---|
| Receipt number | R000045338 |
| Scientific Title | Biliary decompression by new-type slim metal stents for unresectable malignant hilar biliary obstruction: multicenter prospective observational study |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2024/03/28 19:49:45 |
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Basic information
Public title
Biliary decompression
by new-type slim metal stents
for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Acronym
Biliary decompression by new-type slim metal stents
Scientific Title
Biliary decompression
by new-type slim metal stents
for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Scientific Title:Acronym
B-slim
Region
| Japan |
Condition
Condition
unresectable malignant hilar biliary obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the clinical outcomes of new-type biliary slim stents in unresctable malignant hilar biliary obstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patency of new-type stents 6 months after stent placetment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Unresctable malignant hilar obstruction
2) Total bilirubin of 2.0 mg/dL or more before initial biliary decompression
3) Without history of biliary stenting or with no dysfunction of previous biliary stent
4) Prognosis of 6 months or more survival
5) With 6-mm nowvel biliary metal stents intubated
6) Written informed consent
Key exclusion criteria
1) Upper gastrointestinal surgical reconstruction except for Billroth-I anastmosis
2) Scheduled for curative resection of malignant hilar biliary disease
3) After biliary stenting with unremovable biliary stent
4) Necessary for biliary stenting across the major papilla
5) ASA class 4 or more
6) Severe comorbidity/active infection/PSC/PBC/IgG4-SC
7) Judgement by the primary doctor or the medical team
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido 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
Hokkaido University Certified Review Board
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7934
crjimu@huhp.hokudai.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
| 2020 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
None.
Publication of results
Unpublished
Result
URL related to results and publications
None.
Number of participants that the trial has enrolled
14
Results
Thirteen of 14 patients were successfully implanted: 11 by side-by-side technique; 2 by stent-in-stent technique. During the observation period of 286 days (5-727 days), recurrent biliary obstruction (RBO) occurred in 69.2% of patients, and the median time to RBO was 177 days. Compared with previous reports, the results were generally comparable.
Results date posted
| 2024 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unresectable malignant hilar biliary obstruction
Participant flow
1) Confirmation that the patient has unresectable hilar biliary cancer and is eligible for endoscopic biliary stenting, 2) Obtaining informed consent, 3) Biliary stenting, 4) Post-stenting observation
Adverse events
None
Outcome measures
Recurrent biliary obstruction (RBO), the median time to RBO
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective multicenter study
Management information
Registered date
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045338
