臨床研究等提出・公開システム

Japanese

Date of registration	April. 19, 2023
Last modified on	April. 19, 2023
Trial ID	jRCT1040230010

Scientific Title	Development of proactive antimicrobial strategy using novel rapid test complex for microorganisms during pancreatoduodenectomy (DOREMI trial)
Public Title	Development of a novel antimicrobial strategy during pancreatoduodenectomy (DOREMI trial)

Contact for Scientific Queries	Name	Fujii Tsutomu
	Affiliation	University of Toyama
	Address	2630, Sugitani, Toyama
	Telephone	+81-76-434-7331
	E-mail	fjt@med.u-toyama.ac.jp
Contact for Public Queries	Name	Tanaka Haruyoshi
	Affiliation	University of Toyama
	Address	2630, Sugitani, Toyama
	Telephone	+81-76-434-7331
	E-mail	tanakaharu@med.nagoya-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 19, 2023
Actual date of first enrollment		Dec. 01, 2022
Target sample size		150
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	historical control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients are scheduled to undergo pancreaticoduodenectomy. Patients must be at least 20 years of age at the time of enrollment. ECOG PS status 0, 1, or 2 The patient's consent to participate in this study was obtained.
	Exclusion Criteria	History of serious drug hypersensitivity or drug allergy. Patients have obvious preoperative infection or inflammation (e.g., fever over 38.0 digree). Patient has a serious underlying disease (cardiac, pulmonary, metabolic, renal, cirrhosis, bowel obstruction, etc.) and is considered by the surgeon to be at high risk (more than 5%) of surgery-related mortality. Patients have dementia, psychosis, or psychiatric symptoms. Other conditions that make them unsuitable for the study as determined by the study investigator(s).
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		pancreatoduodenectomy
Intervention(s)		For the intervention group, a combined test (RMiX) of the following i-iii will be performed Tmm method: PCR of DNA from body fluids is performed to identify and quantify the initiating organisms by the pattern of Tm values. p16S-PCR method: Designs probe PCR primer and performs targeted determination of bacterial species. ATP-LST method: Susceptibility testing is performed using a reagent that emits luminescence due to the ATP enzyme reaction of bacteria. PAT: Based on the results of RMiX, a treatment plan is discussed.
Health Condition(s) Keyword		pancreatoduodenectomy
Health Condition(s) Code		D016577
Primary Outcome(s)		RMiX-PAT Treatment compliance rate
Secondary Outcome(s)		RMiX Target coverage

Primary Sponsor	University of Toyama

Source of Monetary Support / Secondary Sponsor	2020 President's Discretionary Expenses
Secondary Sponsor	Not applicable

Source of Monetary Support	University of Toyama
Secondary Sponsor	Not applicable

Source of Monetary Support	Kakenhi
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethics Committee, University of Toyama
Address	2630, Sugitani, Toyama, Toyama
Telephone	+81-76-415-8857
E-Mail	rinri@adm.u-toyama.ac.jp
Approval Status	Approval
Date of approval	Feb. 17, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none