UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057002 |
|---|---|
| Receipt number | R000064825 |
| Scientific Title | A Retrospective Observational Study on the Optimal Type and Duration of Prophylactic Antibiotics Following Pancreaticoduodenectomy with Preoperative Biliary Drainage |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/02/12 10:34:30 |
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Basic information
Public title
A Retrospective Observational Study on the Optimal Type and Duration of Prophylactic Antibiotics Following Pancreaticoduodenectomy with Preoperative Biliary Drainage
Acronym
A Study on the Type and Duration of Prophylactic Antibiotics After Pancreaticoduodenectomy
Scientific Title
A Retrospective Observational Study on the Optimal Type and Duration of Prophylactic Antibiotics Following Pancreaticoduodenectomy with Preoperative Biliary Drainage
Scientific Title:Acronym
A Retrospective Observational Study on the Optimal Type and Duration of Prophylactic Antibiotics Following Pancreaticoduodenectomy with Preoperative Biliary Drainage
Region
| Japan |
Condition
Condition
Patients Undergoing Pancreaticoduodenectomy with Preoperative Biliary Drainage
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pancreaticoduodenectomy (PD) is a highly complex surgical procedure for tumors in the pancreatic head region, with a complication rate of approximately 30%. In particular, patients with obstructive jaundice require preoperative biliary drainage, which has been reported as a risk factor for severe surgical site infections (SSI) postoperatively. While some reports suggest that prophylactic broad-spectrum antibiotics can reduce SSI, current guidelines recommend the use of first-generation cephalosporins only on the day of surgery.
Since 2014, our department has determined perioperative antibiotic regimens based on bile culture and sensitivity results obtained during preoperative biliary drainage. Additionally, given the particularly high risk of SSI in patients undergoing preoperative biliary drainage, we have implemented a treatment strategy of administering antibiotics until postoperative day 3.
The aim of this study is to retrospectively evaluate whether extending antibiotic administration until postoperative day 3 (since 2014) reduces SSI compared to administration only on the day of surgery (before 2013) in patients who underwent PD after preoperative biliary drainage at our institution. This study may provide a basis for proposing a new perioperative antibiotic strategy to prevent SSI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the incidence of postoperative infections, including surgical site infection (SSI), intra-abdominal infection, and pancreatic fistula.
Key secondary outcomes
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
Patients who underwent pancreaticoduodenectomy after preoperative biliary drainage at our institution between January 1, 2005, and December 31, 2023, and did not meet the exclusion criteria.
Key exclusion criteria
1. Patients who explicitly expressed their refusal to participate in this study.
2. Patients under the age of 18.
3.Patients deemed unsuitable as study subjects by the principal investigator for any other reason.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimidera, Wakayama City, Wakayama Prefecture, Japan
TEL
073-447-2300
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Matsumoto |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1 Kimidera, Wakayama City, Wakayama Prefecture, Japan
TEL
073-447-2300
Homepage URL
kyohei-m@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Wakayama Medical University School of Medicine
Address
811-1 Kimidera, Wakayama City, Wakayama Prefecture, Japan
Tel
073-447-2300
kyohei-m@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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
352
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study.
The study population includes patients who underwent pancreatoduodenectomy (PD) after preoperative biliary drainage between January 1, 2010, and December 31, 2013, or between January 1, 2014, and December 31, 2023.
Patient selection was conducted with approval from the Ethics Committee of Wakayama Medical University, and informed consent was obtained using an opt-out approach.
Patients in the earlier period (2010-2013) received cefazolin within 24 hours postoperatively for surgical infection prophylaxis, in accordance with clinical guidelines. In contrast, patients from 2014 onward were treated with a different strategy, in which antibiotics were selected based on the culture results and antibiotic susceptibility of the preoperative biliary drainage samples and administered for three days postoperatively.
This study retrospectively examines medical records to determine whether there is a difference in the incidence of surgical site infections (SSI) between these two antibiotic administration strategies.
Management information
Registered date
| 2025 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064825
