Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

Study Overview
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Brief Summary
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Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity. One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP). However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital.. Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs, The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications. The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy. The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.

Official Title
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Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study

Conditions
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Infection, Bacterial

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patient operated for a planned cephalic duodenopancreatectomy Post-operative hospitalisation in ICU Information leaflet given to the patient and the support person, with oral information, during the post-operative period Exclusion Criteria: Age < 18 years Emergency duodenopancreatectomy (surgical indication period less than 48 hours)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cephalic Duodenopancreatectomy<br>Patients who underwent scheduled cephalic duodenopancreatectomy and hospitalized in intensive care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of preoperative Bile and postoperative infection sites microbiology results | bacterial count in log10 bacteria/ml and identification | from date of initial bile sample up to 30 days of postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of prior biliary drainage on the intraoperative bile microbiological results bacteriological results obtained | bacterial count in log10 bacteria/ml and species identification | from date of initial bile sampling to date of surgery (up to 90 days) | 
| Microbial flora in clinical specimens obtained from different sites | bacterial count in log10 bacteria/ml and species identification | from date of initial bile sample up to 90 postoperative days | 
| Non infectious surgical complications using scores | Clavien-Dindo Classification, SOFA score | from date of surgery up to 30 postoperative days | 
| postoperative infectious complications as defined by the Centers for Disease Control and Prevention (Atlanta, Ga) | number of event occurence | During hospital stay (up to 90 days after surgery) | 
| Implication of bacteria found in biliculture as causative agent in post-operative infections | incidence in percentage | During hospital stay (up to 90 days after surg | 
| length of stay in intensive care and hospital | Number of days in ICU and hospital | During the ICU stay and hospital | 
| mortality rate | number of death at 28 days and 90 days | At day +28 and day +90 | 
| Description of nutrition assistance | Parenteral, enteral, oral feeding in days and calories | from date of initial bile sample up to 30 days of postoperative period | 
| Nutritional status measured by nutritional risk index (NRI) | Body mass index (BMI) and albuminemia computation | preoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile colonization, Cephalic Duodenopancreatectomy