UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056774 |
|---|---|
| Receipt number | R000064417 |
| Scientific Title | Piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy: prospective observational study |
| Date of disclosure of the study information | 2025/01/21 |
| Last modified on | 2025/01/21 21:24:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy: prospective observational study
Acronym
Piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy
Scientific Title
Piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy: prospective observational study
Scientific Title:Acronym
Piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Diseases requiring pancreatoduodenectomy (e.g., pancreatic cancer, bile duct cancer)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of piperacillin-tazobactam for antimicrobial prophylaxis during pancreatoduodenectomy
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of postoperative SSI within 30 days.
Key secondary outcomes
30-day mortality, sepsis, septic shock, percutaneous drain placement, pneumonia, postoperative reintubation, prolonged ventilation, venous thromboembolism events, kidney failure, urinary tract infections, stroke, myocardial infarction, cardiac arrest, Clostridioides difficile colitis, hospital readmission, reoperation, and length of hospital stay, postoperative delayed gastric emptying, and pancreatic fistula grade B and grade C defined by International Study Group of Postoperative Pancreatic Fistula.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients for whom pancreatoduodenectomy is being planned
2. Patients must be 18 years of age or older at the time of enrollment
Key exclusion criteria
1. Inability to receive trial antibiotics due to allergy or medical issues
2. Active infection
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Uemura |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
7348551
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL
082-257-5216
umk@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Baba |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Surgery
Zip code
7348551
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
TEL
082-257-5216
Homepage URL
bbkenta@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital
Address
1-2-3,KASUMI, MINAMI-KU, Hiroshima, JAPAN
Tel
082-257-5907
iryo-sinsa@office.hiroshima-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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 21 | 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
| 2024 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not paticular
Management information
Registered date
| 2025 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064417
