UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036315 |
|---|---|
| Receipt number | R000041358 |
| Scientific Title | Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial- |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2021/06/03 23:39:27 |
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Basic information
Public title
Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial-
Acronym
Efficacy of inside stent placement for mmalignant hilar biliary obstruction
Scientific Title
Efficacy of inside plastic stent placement for malignant hilar biliary obstruction -multicenter, randomized control trial-
Scientific Title:Acronym
Efficacy of inside stent placement for mmalignant hilar biliary obstruction
Region
| Japan |
Condition
Condition
malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of inside plastic stent placement for malignant hilar biliary obstruction compared to across
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to recurrent biliary obstruction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Compare the methods of biliary stent placement
Across the papilla vs above the papilla
Interventions/Control_2
Above the papilla
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
1 Patients with malignant hilar biliary obstruction
2 Unresectable malignant tumor
3 The malignant tumor was confirmed by pathoological examination or obviously diagnosed by the images
4 Need to drainage for obstructive jaundice
Key exclusion criteria
1 Difficult to access the biliary duct by endoscopy
2 Patients have previously recieved upper GI reconstruction.
3 benign obstruction
4 pregnancy
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Isayama |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku Tokyo Japan
TEL
0358021060
h-isayama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Fujisawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku Tokyo Japan
TEL
0358021060
Homepage URL
t-fujisawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku Tokyo Japan
Tel
0338133111
kenkyu5858@juntendo.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
| 2019 | Year | 04 | Month | 01 | 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
| 2019 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041358
