Pancreatic SurgeryICADINCT07531420
Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy
An observational study of Pancreatic Surgery and Antibiotic Prophylaxis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Surgery, Antibiotic Prophylaxis, Surgical Site Infection (SSI)
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing pancreaticoduodenectomy for malignancy with preoperative biliary drainage at Nancy University Hospital between January 2022 and December 2025.
Who may be able to join
- Adult patients (> 18 yrs)
- Scheduled for pancreatic surgery
- Presence of preoperative biliary stent
- Postoperative admission to surgical ICU or intermediate care unit
Who cannot join
- decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Antibiotic Prophylaxis Modification on Surgical Site Infections Following Pancreaticoduodenectomy: The Role of Local Microbiological Ecology (ICADI Study)
Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. However, the relevance of this strategy may depend on local microbiological ecology.
This monocentric ambispective cohort study aims to compare SSI rates between two periods: before and after implementation of piperacillin/tazobactam prophylaxis. The study also evaluates microbiological profiles of bile cultures, antibiotic susceptibility, and postoperative antibiotic exposure.
The primary hypothesis is that adaptation of antibiotic prophylaxis to local ecology may optimize outcomes while limiting unnecessary exposure to broad-spectrum antibiotics.
- Conditions
- Pancreatic Surgery, Antibiotic Prophylaxis, Surgical Site Infection (SSI), Surgical Site Infection Prevention
- Keywords
- cefazolin, piperacillin/tazobactam
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Period 1 (2022 - 2023) | Adult patients scheduled for pancreatic surgery receiving cefazolin as antibiotic prophylaxis | |
| Period 2 (2024 - 202() | Adult patients scheduled for pancreatic surgery receiving piperacillin/taazobactam as antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
Measured: Day 30
Secondary outcomes (3)
Pancreatic fistula rate within 30 days after pancreaticoduodenectomy
Measured: Day 30
Postoperative carbapenem exposure
Measured: Day 30
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam isolated by the bile culture sampled during the pancreatic surgery
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic SurgeryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531420
- Sponsor's protocol ID
- 2024PI155
- Acronym
- ICADI
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Prophylaxis Modification on Surgical Site Infections Following Pancreaticoduodenectomy: The Role of Local Microbiological Ecology (ICADI Study)
- ClinicalTrials.gov ID
- NCT07531420
- Acronym / sponsor ID
- ICADI / 2024PI155
- Conditions
- Pancreatic Surgery, Antibiotic Prophylaxis, Surgical Site Infection (SSI), Surgical Site Infection Prevention
- Keywords
- cefazolin, piperacillin/tazobactam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. However, the relevance of this strategy may depend on local microbiological ecology.
This monocentric ambispective cohort study aims to compare SSI rates between two periods: before and after implementation of piperacillin/tazobactam prophylaxis. The study also evaluates microbiological profiles of bile cultures, antibiotic susceptibility, and postoperative antibiotic exposure.
The primary hypothesis is that adaptation of antibiotic prophylaxis to local ecology may optimize outcomes while limiting unnecessary exposure to broad-spectrum antibiotics.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 (2022 - 2023) | – | –Adult patients scheduled for pancreatic surgery receiving cefazolin as antibiotic prophylaxis |
| Period 2 (2024 - 202() | – | –Adult patients scheduled for pancreatic surgery receiving piperacillin/taazobactam as antibiotic prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing pancreaticoduodenectomy for malignancy with preoperative biliary drainage at Nancy University Hospital between January 2022 and December 2025.
Key inclusion criteria (4 listed)
- Adult patients (> 18 yrs)
- Scheduled for pancreatic surgery
- Presence of preoperative biliary stent
- Postoperative admission to surgical ICU or intermediate care unit
Key exclusion criteria (1 listed)
- decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
Time frame: Day 30
3 secondary outcomes
Pancreatic fistula rate within 30 days after pancreaticoduodenectomy
Time frame: Day 30
Postoperative carbapenem exposure
Time frame: Day 30
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Surgery and Antibiotic Prophylaxis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.