UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005182 |
|---|---|
| Receipt number | R000006146 |
| Scientific Title | A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2015/03/05 15:37:28 |
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Basic information
Public title
A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture
Acronym
A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture
Scientific Title
A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture
Scientific Title:Acronym
A prospective randomized controlled multicenter study of unilateral drainage versus bilateral drainage for malignant hilar biliary stricture
Region
| Japan |
Condition
Condition
Advenced biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate stent patency and complication of unilateral drainage versus bilateral drainage with metallic stents for maliganat hilar biliary stricture
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
duration from stent deployment to re-intervention
Key secondary outcomes
1. over all survival
2. complication rate
3. rate of stent patency at death
4. rate of application of endoscopic re-intervention to first stent occlusion and success rate of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
unilateral drainage
Interventions/Control_2
bilateral drainage
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
1. The patients who have biliary tract carcionoma with type2, 3a, 3b, or 4 hilar biliary stricture according to Bismuth's classification and with abnormal liver function tests
2. The liver funstion tests improve after unirateral drainage with transpapillary endoscopic naso-biliary drainage using plastic stents within four weeks.
3. Biliary tract cancer which is histologically or cytologically proven malignancy
4. Atrophy of the liver is not found due to vascular invasion.
5. Unresectable biriary tract cancer over stage 2b according to TNM classification
6. Patients fully understand and are willing to give a written informed consent about participation.
Key exclusion criteria
1. Performance status is 4.
2. ASA calassification is over 3.
3. Informed consent is not achieved.
4. Patients considered ineligible for this study.
5. The prognosis is considered within three months.
6. Patients who recieved additional treatment after initial unilateral drainage with naso-biliary plastic stents
7. Left or right lobe is occupied by the tumor.
8. Transpapillary deployment of metallic stents is not achieved.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kawamoto |
Organization
Kawasaki Medical Hospital
Division name
General intermedicine 2
Zip code
Address
Matsushima 577, Kurashiki city, Okayama 701-0192, Japan
TEL
086-225-2111
h.kawamoto@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 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, Kitaku, Okayama 700-8558, Japan
TEL
086-235-7219
Homepage URL
drkatocha@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical 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
Other administrative information
Date of disclosure of the study information
| 2011 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 03 | Day |
Last modified on
| 2015 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006146
