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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024259
Receipt No. R000027929
Scientific Title Does oral care prevent post-ESD-pneumonia?
Date of disclosure of the study information 2016/10/10
Last modified on 2016/10/02

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Basic information
Public title Does oral care prevent post-ESD-pneumonia?
Acronym ESD oral care study
Scientific Title Does oral care prevent post-ESD-pneumonia?
Scientific Title:Acronym ESD oral care study
Region
Japan

Condition
Condition early gastric cancer/gastric adenoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We consider whether oral care is useful for post-ESD-pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post-ESD-pneumonia rate
Key secondary outcomes Post-ESD-fever, inflammatory reaction, hospitalization period and fee

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Oral care is performed.
Interventions/Control_2 Oral care is not performed.
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) Clinical diagnosis of Stage IA early gastric cancer or gastric adenoma, and suspicion for Stage IA early gastric cancer or gastric adenoma.
2) 20 years old or older.
3) Obtain patients consent
Key exclusion criteria Unsuitable patient
Target sample size 302

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Akazawa
Organization Nagasaki University Hospital
Division name Department of Pathology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7562
Email akazaway@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taro Akashi
Organization Nagasaki University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7481
Homepage URL
Email fuk_naga_ta23@yahoo.co.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Nagasaki University Hospital
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
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 長崎大学病院(長崎県)
JCHO諫早総合病院(長崎県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 10 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 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
2016 Year 10 Month 02 Day
Last modified on
2016 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027929

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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