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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031756
Receipt No. R000036254
Scientific Title The efficacy and the safety of Interventional EUS; the retrospective study
Date of disclosure of the study information 2018/03/16
Last modified on 2019/03/17

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Basic information
Public title The efficacy and the safety of Interventional EUS; the retrospective study
Acronym The efficacy and the safety of Interventional EUS; the retrospective study
Scientific Title The efficacy and the safety of Interventional EUS; the retrospective study
Scientific Title:Acronym The efficacy and the safety of Interventional EUS; the retrospective study
Region
Japan

Condition
Condition Pancreatic fluid collection, Obstructive jaundice, Abdominal abscess, Obstructive pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of interventional EUS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events rate
Key secondary outcomes Technical success and clinical success

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 The patients who underwent interventional EUS
Key exclusion criteria The patients who want to opt out
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Hironari
Middle name
Last name Kato
Organization Okayama University Hospital
Division name Gastroenterology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Email yksk-tkhk@k8.dion.ne.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Uchida
Organization Okayama University Hospital
Division name Gastroenterology
Zip code 700-8558
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-7219
Homepage URL
Email d.uchida0309@gmail.com

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
Tel 086-235-6938
Email mae6605@adm.okayama-u.ac.jp

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 03 Month 16 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 Open public recruiting
Date of protocol fixation
2014 Year 10 Month 04 Day
Date of IRB
2014 Year 11 Month 26 Day
Anticipated trial start date
2014 Year 11 Month 27 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The 130 patients were registered and evaluated.

Management information
Registered date
2018 Year 03 Month 16 Day
Last modified on
2019 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036254

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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