Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy (ICADI)

April 9, 2026 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France
        • University Hospital of Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing pancreaticoduodenectomy for malignancy with preoperative biliary drainage at Nancy University Hospital between January 2022 and December 2025.

Description

Inclusion Criteria:

  • Adult patients (> 18 yrs)
  • Scheduled for pancreatic surgery
  • Presence of preoperative biliary stent
  • Postoperative admission to surgical ICU or intermediate care unit

Exclusion Criteria:

  • decline to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
Time Frame: Day 30
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic fistula rate within 30 days after pancreaticoduodenectomy
Time Frame: Day 30
Day 30
Postoperative carbapenem exposure
Time Frame: Day 30
Day 30
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam
Time Frame: Day 1
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam isolated by the bile culture sampled during the pancreatic surgery
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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