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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009394
Receipt No. R000011035
Scientific Title The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage
Date of disclosure of the study information 2012/11/27
Last modified on 2020/06/04

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Basic information
Public title The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage
Acronym Metallic stent for EUS-guided pseudocyst drainage
Scientific Title The safety and effectiveness of fully covered self-expanding metallic stent for EUS-guided transenteric pancreatic pseudocyst drainage
Scientific Title:Acronym Metallic stent for EUS-guided pseudocyst drainage
Region
Japan

Condition
Condition pancreatic pseudocyst which is required drainage
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of safety and efficacy of a fully covered metallic stent for enterocystostomy and related procedure in the treatment of pancreatic pseudocyst
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The rate ofsuccessful placement
Key secondary outcomes The rate ofcomplication and clinical success

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 metallic stent for transenteric pancreatic pseudocyst drainage
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 Pancreatic psedocyst which did not respond to convervative treatment.
Pseudocyst which is contact to stomach or duodenum
Informed consent is obtained
Key exclusion criteria Massive ascites
Multiple organ failure
Pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
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 03-3815-5411
Email natsuyo@tke.att.ne.jp

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 03-3815-5411
Homepage URL
Email natsuyo@tke.att.ne.jp

Sponsor
Institute Department of Gastroenterology,The University of Tokyo
Institute
Department

Funding Source
Organization Department of Gastroenterology,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
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
2012 Year 11 Month 27 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
2012 Year 08 Month 01 Day
Date of IRB
2012 Year 07 Month 02 Day
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2014 Year 07 Month 30 Day
Date of closure to data entry
2014 Year 12 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 25 Day
Last modified on
2020 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011035

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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