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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004547
Receipt No. R000005417
Scientific Title The study of the usefulness of a continuous suction on the lower pharynx for preventing from aspiration during endoscopic submucosal dissection for gastric cancer and adenoma
Date of disclosure of the study information 2010/12/01
Last modified on 2014/06/25

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Basic information
Public title The study of the usefulness of a continuous suction on the lower pharynx for preventing from aspiration during endoscopic submucosal dissection for gastric cancer and adenoma
Acronym The study of the continuous suction on the lower pharynx during ESD for gastric cancer and adenoma
Scientific Title The study of the usefulness of a continuous suction on the lower pharynx for preventing from aspiration during endoscopic submucosal dissection for gastric cancer and adenoma
Scientific Title:Acronym The study of the continuous suction on the lower pharynx during ESD for gastric cancer and adenoma
Region
Japan

Condition
Condition Dysphagia, Gastric cancer and adenoma
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Study the usefulness of the continuous suction on the lower pharynx for preventing from aspiration during endoscopic submucosal dissection for gastric cancer and adenoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of the chest CT, body temperature, white blood counts, C reactive protein and SpO2.
Key secondary outcomes The suction volume of saliva during ESD.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Continuous suction on the lower pharynx.
Interventions/Control_2 Suction on the pharynx when it needs.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are performed ESD for gastric cancer in our hostpital.
Key exclusion criteria The patients who were performed tracheotomy.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoyoshi Izumi
Organization Machida municipal hospital
Division name Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo, Japan
TEL 042-722-2230
Email m.izumi@machida-city-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Tanida
Organization Machida municipal hospital
Division name Gastroenterology
Zip code
Address 2-15-41, Asahi-machi, Machida-city, Tokyo, Japan
TEL 042-722-2230
Homepage URL
Email e.tanida@machida-city-hp.jp

Sponsor
Institute Machida municipal hospital
Institute
Department

Funding Source
Organization Machida municipal hospital
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 町田市民病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 12 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005417

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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