Colonization of Bile Ducts and Infectious Complications in Cephalic Duodenopancreatectomy

Completed

• Conditions: Infection, Bacterial

• Registration Number: NCT04555252
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2020-07
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Primary Completion: 2021-03-28
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of preoperative Bile and postoperative infection sites microbiology results	from date of initial bile sample up to 30 days of postoperative period	bacterial count in log10 bacteria/ml and identification

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chru Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France