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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004405
Receipt No. R000005131
Scientific Title The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction
Date of disclosure of the study information 2010/10/25
Last modified on 2013/01/09

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Basic information
Public title The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction
Acronym Inner coated ComVi stent for distal malignant biliary obstruction
Scientific Title The efficacy and safety of inner coated ComVi stent for management of distal malignant biliary obstruction
Scientific Title:Acronym Inner coated ComVi stent for distal malignant biliary obstruction
Region
Japan

Condition
Condition Cases of distal malignant biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The evaluation of the safety and efficacy of a newly designed metallic stent (inner ComVi stent)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Patency of Inner coated ComVi stent
Key secondary outcomes Compliation
Median survival period of cases

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
Device,equipment
Interventions/Control_1 Placement of inner coated ComVi stent for the cases of distal malignant 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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)The Case of distal malignant biliary obstruction
2)The level of total bilirubin is more than 3mg/dl.
3)The expected life expectancy for the patients is more than two months.
4)Written informed consent is obtained.
5)Activity of the case is considered as 0 to 2 by ECOG performance status score.
Key exclusion criteria 1) Ascites
2) Severe coexisting illness
3) Inaccessible to duodenal papilla due to post surgical status
4) Difficult cannulation to duodenal papilla
5) Intestinal or colonic obstruction
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3815-5411ext.33070
Email

Public contact
Name of contact person
1st name
Middle name
Last name Natsuyo Yamamoto
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3815-5411ext.33070
Homepage URL
Email natsuyo@tke.att.ne.jp

Sponsor
Institute The University of Tokyo,Department of Gastroenterology
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 東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 25 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
2010 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
2012 Year 11 Month 25 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 18 Day
Last modified on
2013 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005131

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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