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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000000738
Receipt No. R000000886
Scientific Title A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Date of disclosure of the study information 2007/06/11
Last modified on 2009/12/25

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Basic information
Public title A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Acronym A randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Scientific Title A prospective single blind randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Scientific Title:Acronym A randomized controlled trial of covered versus uncovered biliary metal stents for the management of distal malignant biliary obstruction.
Region
Japan

Condition
Condition Distal malignant biliary obstraction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the patency between covered metallic stents and uncovered metallic stents for the patients of distal malignant biliary obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Comparison of the duration of the stents patency
Key secondary outcomes comparison of the safty
comparison of the cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Insertion of covered self expandable metal stents
Interventions/Control_2 Insertion of uncovered self expandable metal stents
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, Patinets who are admitted in the International Medical Center of Japan (IMCJ).
2, Obstraction of the distal bile duct without hilar lesions because of tumor invasion or compression of metastatic lymph nodes.
3, The tumors are unresectable because of tumor progression and/or patient's complications.
4, Performance status (PS) are 0 to 3.
Key exclusion criteria 1, Patients with severe dysfunction of liver, kidney, heart, or lung.
2, Patients who are estimated to die within two months.
3,Patients with history of insertion of biliay metal stents
4, Patients with history of surgery of the common bile ducts.
5, Patients with stenosis of the hepatic ducts or the intra hepatic bile ducts.
6, Patients with stenosis of the duodenum which prevent passage of foods.
Target sample size 112

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Kobayakawa
Organization International Medical Center of Japan
Division name Department of gastroenterology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization International Medical Center of Japan
Division name Department of gastroenterology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
Email mkobaya@imcj.hosp.go.jp

Sponsor
Institute International Medical Center of Japan
Institute
Department

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
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
2007 Year 06 Month 11 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
2007 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2011 Year 09 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
2007 Year 06 Month 08 Day
Last modified on
2009 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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