Development of a novel antimicrobial strategy during pancreatoduodenectomy

JRCT ID: jRCT1040230010

Registered date:19/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatoduodenectomy
• Date of first enrollment: 01/12/2022
• Target sample size: 150
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: RMiX-PAT Treatment compliance rate
• Secondary Outcome: RMiX Target coverage

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Fujii Tsutomu
• Source(s) of Monetary Support: 2020 President's Discretionary Expenses,University of Toyama,Kakenhi