UMIN-CTR Clinical Trial

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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