UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007131 |
|---|---|
| Receipt number | R000008391 |
| Scientific Title | Safety and efficacy of Fully-covered WallFlex stent in patients with distal malignant biliary obstruction: a prospective multicenter study |
| Date of disclosure of the study information | 2012/01/24 |
| Last modified on | 2013/07/24 10:40:18 |
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Basic information
Public title
Safety and efficacy of Fully-covered WallFlex stent in patients with distal malignant biliary obstruction: a prospective multicenter study
Acronym
WATCH-2 study
Scientific Title
Safety and efficacy of Fully-covered WallFlex stent in patients with distal malignant biliary obstruction: a prospective multicenter study
Scientific Title:Acronym
WATCH-2 study
Region
| Japan |
Condition
Condition
Malignant biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the patency and safety of Fully-covered WallFlex stent for unresectable distal malignant biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Stent patency period
Key secondary outcomes
Time to dysfunction, Stent occlusion rate, Stent-related complication rate, Overall survival
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
Fully-covered WallFlex stent
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) Patients with unresectable distal malignant biliary obstruction, not limited to primary disease.
2) Patients with predictable prognosis of more than 2 months.
3) Patients with written informed consent.
4) Patients with performance status 0-2.
Key exclusion criteria
1) Patients with massive ascites.
2) Patients with severely impaired organ function.
3) Patients for whom endoscopic biliary drainage is difficult.
4) Patients with duodenal obstruction.
5) Patients considered ineligible for this study.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shomei Ryozawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-Chuo, Tsuzuki-ku, Yokohama
TEL
045-949-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Kogure |
Organization
Faculty of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, The University of Tokyo
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
| 2012 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2012 | Year | 01 | Month | 24 | Day |
Last modified on
| 2013 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008391
