UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005182
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email drkatocha@yahoo.co.jp

Sponsor
Institute Kawasaki Medical Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.