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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030898
Receipt No. R000035281
Scientific Title The strategy of endoscopic intervention for pancreatic fluid collection
Date of disclosure of the study information 2018/01/19
Last modified on 2018/07/22

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Basic information
Public title The strategy of endoscopic intervention for pancreatic fluid collection
Acronym The strategy of endoscopic intervention for pancreatic fluid collection
Scientific Title The strategy of endoscopic intervention for pancreatic fluid collection
Scientific Title:Acronym The strategy of endoscopic intervention for pancreatic fluid collection
Region
Japan

Condition
Condition Pancreatic fluid collection after acute pancreatitis (Pancreatic pseudocyst; PPC, Walled-off necrosis; WON)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of EUS-guided transluminal drainage (EUS-TD) and step up approach for PPC or WON
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical success rate of EUS-TD and step up
approach
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patient with done EUS-TD for PPC/WON
Key exclusion criteria Patient with done EUS-TD for disease other than PPC/WON
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Shiomi
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Email hshiomi@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Shiomi
Organization Kobe University Graduate School of Medicine
Division name Division of Gastroenterology, Department of Internal medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-6305
Homepage URL
Email hshiomi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
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
2018 Year 01 Month 19 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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2018 Year 02 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 none

Management information
Registered date
2018 Year 01 Month 19 Day
Last modified on
2018 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035281

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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