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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039052
Receipt No. R000044534
Scientific Title Prospective exploratory study about the cause of fever in the post EMR & ESD patients
Date of disclosure of the study information 2020/01/06
Last modified on 2020/01/15

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Basic information
Public title The study for the cause of fever in the post EMR & ESD patients
Acronym DEEP study
Scientific Title Prospective exploratory study about the cause of fever in the post EMR & ESD patients
Scientific Title:Acronym DEEP study
Region
Japan

Condition
Condition Digestive epithelial tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To unveil the cause of fever in the post EMR & ESD patients
Basic objectives2 Others
Basic objectives -Others Epidemiological surveillance of disease prevalence
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cause of fever after gastrointestinal tract ESD or duodenal EMR
Key secondary outcomes 1) The relationship between aspiration pneumonia and infused water volume, location, surgeon, age and operation time
2) The relationship between PECS (post-ESD coagulation syndrome)or mediastinitis and injected water volume, location, operator, age and operation time
3) The ratio and comparison of aspiration pneumonia by organ
4) The ratio and comparison of PECS or mediastinitis by organ

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing total gastrointestinal tract ESD or duodenal EMR at our hospital and providing written informed consent
Key exclusion criteria 1) Patients with multiple lesions
2) Patients with severe respiratory failure.
3) Patients with severe heart failure.
4) Patients with valvular disease.
5) Patients with uncompensated cirrhosis.
6) Patients on dialysis.
7) Patients with immunodeficiency or who taking continuous systemic administration of immunosuppressants.
8) Patients who taking antipyretic analgesics periodically.
9) Patients with perforation during procedure.
10) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Motohiko
Middle name
Last name Kato
Organization Keio University School of Medicine
Division name Gastroenterology / Cancer center
Zip code 160-8582
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-5363-3437
Email motohikokato@keio.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Mizutani
Organization Keio University School of Medicine
Division name Gastroenterology / Cancer center
Zip code 160-8582
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-5363-3437
Homepage URL
Email marimizutani6@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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 Keio University School of Medicine
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel 03-5363-3437
Email marimizutani6@keio.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 慶應義塾大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 06 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
2020 Year 01 Month 04 Day
Date of IRB
2018 Year 12 Month 08 Day
Anticipated trial start date
2020 Year 01 Month 04 Day
Last follow-up date
2021 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information When the patient has over 37.5 degrees fever after gastrointestinal tract ESD / duodenal EMR, we perform CT scam.

Management information
Registered date
2020 Year 01 Month 04 Day
Last modified on
2020 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044534

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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