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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007549
Receipt No. R000008915
Scientific Title Covered metallic stent for biliary or pancreatic duct stricture in patients with chronic pancreatitis.
Date of disclosure of the study information 2012/03/21
Last modified on 2014/04/22

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Basic information
Public title Covered metallic stent for biliary or pancreatic duct stricture in patients with chronic pancreatitis.
Acronym Covered metallic stent for biliary or pancreatic duct stricture in patients with chronic pancreatitis.
Scientific Title Covered metallic stent for biliary or pancreatic duct stricture in patients with chronic pancreatitis.
Scientific Title:Acronym Covered metallic stent for biliary or pancreatic duct stricture in patients with chronic pancreatitis.
Region
Japan

Condition
Condition chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the safety and efficacy of covered metallic stent.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Recurrence rates after removal of covered metallic stent
Key secondary outcomes Complications of placement of covered metallic stent

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 Covered metallic 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 Refractory biliary or pancreatic duct stricture by classical endoscopic treatment with plastic stent
Key exclusion criteria poor general condition
inaccessable to papilla by endoscopy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Graduate school 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
Email isayama-2im@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Sasahira
Organization Graduate school 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
Email sasahira-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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
2012 Year 03 Month 21 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
2008 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 21 Day
Last modified on
2014 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008915

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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