UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014111 |
|---|---|
| Receipt number | R000016427 |
| Scientific Title | Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction: Prospective,multicenter,single-arm study. |
| Date of disclosure of the study information | 2014/06/03 |
| Last modified on | 2014/11/29 23:38:35 |
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Basic information
Public title
Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction:
Prospective,multicenter,single-arm study.
Acronym
Inside stent study for preoperative biliary drainage.
Scientific Title
Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction:
Prospective,multicenter,single-arm study.
Scientific Title:Acronym
Inside stent study for preoperative biliary drainage.
Region
| Japan |
Condition
Condition
malignant hilar biliary obstruction.
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate Efficacy and Safety of inside stent for preoperative biliary drainage in patients with malignant hilar biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
preoperative complication rate
Key secondary outcomes
postoperative complication rate.
3 month postoperative mortality.
Technical success rate of endoscopic biliary stenting.
Clinical success rate of preoperative biliary drainage.
Patency of inside stent.
Success rate of re-intervention.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inside-stent placement for preoperative biliary drainage in patients with malignant hilar biliary obstruction.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Malignant hilar obstruction of cancer of the biliary tract with indication for operation.
Key exclusion criteria
ECOG Performance Status is 4.
ASA grade is 3-5.
Hilar obstruction of HCC or metastatic tumor.
Previous plastic stent placement across the sphincter of Oddi.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Hospital
Division name
Department of gastroenterology and hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Akimoto |
Organization
Okayama University Hospital
Division name
Department of gastroenterology and hepatology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558
TEL
086-235-7219
Homepage URL
qttsp974@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
Address
Tel
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
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 03 | 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
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 29 | Day |
Last modified on
| 2014 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016427
