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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036398
Receipt No. R000041467
Scientific Title Investigation for the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection for the treatment of esophageal and gastric neoplasms.
Date of disclosure of the study information 2019/04/03
Last modified on 2019/04/03

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Basic information
Public title Investigation for the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection for the treatment of esophageal and gastric neoplasms.
Acronym Investigation for the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection for the treatment of esophageal and gastric neoplasms.
Scientific Title Investigation for the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection for the treatment of esophageal and gastric neoplasms.
Scientific Title:Acronym Investigation for the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection for the treatment of esophageal and gastric neoplasms.
Region
Japan

Condition
Condition neoplasms in the esopagus and stomach
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of overtube to prevent aspiration pneumonia after endoscopic submucosal dissection(ESD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of aspiration pneumonia one day after ESD.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 a group with overtube
Interventions/Control_2 a group without overtube
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
80 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients over 80 years old who undertake upper gastrointesitnal ESD.
Key exclusion criteria Patients-
with lesion in cervical esophagsus.
who are expected to be difficult in placing overtube after radiation therapy in pharynx/larynx and neck region.
who develop delayed bleeding or perforation between ESD and obtaining CT.
Target sample size 216

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Araki
Organization Gifu University Hospital
Division name Gastroenterology
Zip code 501-1194
Address 1-1, Yanagido, Gifu
TEL 058-230-6308
Email araara2008@gmail.com

Public contact
Name of contact person
1st name Arao
Middle name
Last name Masamichi
Organization Gifu University Hospital
Division name Gastroenterolgoy
Zip code 501-1194
Address 1-1, Yanagido, Gifu
TEL 058-230-6308
Homepage URL
Email aryao_poor_boy@yahoo.co.jp

Sponsor
Institute Gifu University
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 Gifu University
Address 1-1, Yanagido
Tel 059-230-6308
Email arao@gifu-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
2019 Year 04 Month 03 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
2019 Year 04 Month 03 Day
Date of IRB
2018 Year 11 Month 21 Day
Anticipated trial start date
2019 Year 04 Month 03 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 03 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041467

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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