UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006779 |
|---|---|
| Receipt number | R000008023 |
| Scientific Title | Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction. A prospective phase II trial. |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2019/03/04 18:00:48 |
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Basic information
Public title
Plastic stent placement above the
sphincter of Oddi ("inside-stent") for
patients of malignant hilar biliary obstruction. A prospective phase II trial.
Acronym
Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant hilar biliary obstruction.
Scientific Title
Plastic stent placement above the
sphincter of Oddi ("inside-stent") for
patients of malignant hilar biliary obstruction. A prospective phase II trial.
Scientific Title:Acronym
Plastic stent placement above the sphincter of Oddi ("inside-stent") for patients of malignant 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 evaluate the efficancy and safety of plastic stent placement above the sphincter of Oddi for patients of malignant hilar biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to dysfunction
Key secondary outcomes
1.Dysfunction rate and substance
2.Complication rate and substance
3.Suvival time
4.Re-intervention rate and method
5.Operation time
6.success rate of operation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A plastic stent which is attached a nylon string is used. The plastic stent is placed endoscopically above the sphincter of Oddi for 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Unresectable malignant hilar biliary obstruction is proven by pathological or radiological diagnosis.
2.A stent placement is needed.
3.The therapy of a stent placement have never been performed.
4.Endoscopic stenting can be performed.
5.A stent can be placed above the sphincter of Oddi.
6.Written informed concent of the print.
Key exclusion criteria
1.The prognosis is considered within 3 months.
2.They have jaundice which can't be improved by stenting. For example, liver failure.
3.Decision of unsuitableness by principal investigator.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Sugimori |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
ycu.umin@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Ishii |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
tishii@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Gastroenterological Center
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学附属市民総合医療センター(神奈川県）
神奈川県立がんセンター（神奈川県）
昭和大学藤が丘病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008023
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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